BIOCHEMIST JOB DESCRIPTION

On a given week, a Biochemist in biopharmaceutical manufacturing executes conjugation runs against a production schedule and reviews completed batch records for documentation gaps before a lot ships. Those two activities sit at the center of a role that owns both bench execution and compliance traceability within a GMP-regulated facility. ISO 13485 and FDA 21 CFR requirements govern every step, from equipment qualification through CAPA closure. Without consistent, audit-ready output at this level, product investigations multiply and regulatory inspections expose gaps that upstream scientists cannot fix.

Biochemists in biotechnology and biopharmaceutical manufacturing are accountable for producing proteins, antibodies, and intermediate reagents to specification while maintaining full GMP and GDP documentation across every production run. The role sits within a manufacturing or process development team, typically reporting to a production supervisor or team lead, and interfaces directly with QA personnel on deviation investigations, change controls, and continuous improvement activities.

Career Impact: Hands-on mastery of conjugation, affinity chromatography, and ISO 13485-governed batch documentation gives manufacturing Biochemists a qualification profile that is valued across IVD, biologics, and vaccine production employers.

Business Impact: Every lot this role releases or flags for investigation directly determines product availability for clinical trials, diagnostic customers, and downstream manufacturing groups who cannot substitute the intermediate reagent.

Growth Opportunity: Demonstrated competency in process optimization and validation qualification opens a defined path toward Process Development Scientist and Manufacturing Lead roles with expanding cross-functional scope.

• Execute conjugation and purification runs for proteins, antibodies, and intermediate reagents to meet production schedule targets.
• Maintain batch records, log sheets, and laboratory notebooks in full compliance with GMP and GDP documentation standards.
• Perform quality testing on in-process, bulk, and finished samples, including endotoxin assays and concentration determinations.
• Monitor inventory status for raw materials and intermediate reagents, escalating shortfalls to area management before production is affected.
• Participate in equipment qualification activities including IQ/OQ/PQ, calibration scheduling, and preventive maintenance coordination.
• Support deviation investigations and CAPA closure by gathering data, documenting findings, and implementing corrective steps within defined timelines.
• Collaborate with QA personnel during internal and external audits to demonstrate process adherence and document readiness.
• Train junior manufacturing personnel on conjugation techniques, documentation requirements, and safety protocols.

• Bachelor's degree in Biochemistry, Biology, Chemistry, or a related life science field, or equivalent work experience.
• 2 or more years of hands-on laboratory experience in a GMP or GLP manufacturing environment, with direct exposure to conjugation or purification operations.
• Working knowledge of FDA 21 CFR, ISO 13485, and cGMP requirements as they apply to production documentation and quality systems.
• Demonstrated proficiency in protein or antibody purification techniques including affinity, ion exchange, or size exclusion chromatography.
• Ability to perform and interpret standard analytical assays such as ELISA, endotoxin testing, and concentration measurement by UV spectroscopy.
• Proven competency in maintaining accurate, audit-ready batch records, electronic laboratory notebooks, and equipment logs.
• Strong organizational and time management skills to manage concurrent production assignments against fixed due dates.

• Experience with lyophilization, formulation development, or IVD diagnostic product manufacturing in an FDA or ISO-regulated facility.
• Familiarity with ERP-based work order creation and material transfer processes in a production environment.
• Prior involvement in process validation activities including equipment qualification or change control project execution.
• Knowledge of hybridoma cell culture, antigen production, or recombinant protein expression methods in a manufacturing context.

• On-time lot completion rate, reflecting adherence to the production schedule across assigned conjugation runs.
• Batch record rejection rate, measuring documentation accuracy before QA review and release.
• CAPA closure time in days, tracking how quickly this individual resolves assigned corrective actions after deviation identification.
• Endotoxin and QC pass rate on first test, indicating conjugation yield consistency and technique control.
• Audit observation count attributable to this role's documentation or process execution, reviewed at each inspection cycle.
• Typical tools: Chromatography systems (commonly AKTA Pure or equivalent); laboratory information management systems (commonly ERP-integrated LIMS or equivalent).

• Base Salary Range: $55,000 to $80,000 per year depending on experience and location.
• Bonus: Annual performance bonus of 5 to 10 percent of base salary, where applicable.
• Equity: Not typical at this level; offered selectively at larger biotech employers.
• Health Benefits: Medical, dental, and vision coverage; employer contributes to premiums.
• PTO: 15 to 20 days per year plus standard federal holidays.
• Common Perks: Tuition reimbursement, safety certification support, and lab-coat or PPE allowance.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Background check completion, including employment history and, where applicable, drug screening, is required as a condition of employment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available to individuals with disabilities throughout the application and employment process upon request. Candidates must be authorized to work in the United States.

The Biochemist I owns independent execution of single and multiple-step conjugation processes, directly supporting laboratory productivity by completing assignments with good quality and yield on schedule. Reporting to the immediate supervisor and assisting with day-to-day operations, this Biochemist I enables consistent output across all conjugation formats within the team framework.

Key Responsibilities

• Perform different conjugation formats accurately and independently with a complete understanding of the techniques, theories and background involved.
• Maintain consistency in technique, documentation, data entry, labeling, aliquot of QC samples, and equipment operation.
• Meet production specifications with assignments and commit to due dates.
• Understand background and critical points to chemistry involved in making assignments through training and reading.
• Review and address issues during batch record and other document review to minimize business impact.
• Follow all departmental guidelines and procedures.
• Promote a safe work environment and participate in Environmental Health and Safety programs.
• Participate in addressing corrective actions whenever a hazard is identified and notify supervisor of unsafe work practices.
• Perform duties as assigned by supervisor and trainer, following their instructions.
• Participate in lab supply orders, reagent preparations, and equipment maintenance.

Required Qualifications

• Minimum Bachelor's degree in a biological or chemistry science discipline.
• 0-2 years of relevant experience.
• General knowledge of biology, biochemistry, or other related discipline.
• Familiarity with operation of routine laboratory instruments and applicable software.
• Demonstrated ability to follow established policies and procedures and keep neat, accurate, and complete records and logs.
• Excellent interpersonal, oral, and written communication skills.
• Effective analytical, problem-solving, organization, and planning skills.
• Flexibility and adaptability.
• Knowledge of general laboratory safety.

Embedded within a multidisciplinary clinical environment, the Biochemist collaborates with clinician leaders on best practices and standards of care while contributing to publications and presentations. Working closely with physicians, nurses, and laboratory scientist staff across all testing sites, this Biochemist advances diagnostic quality and regulatory readiness through expert interpretation, staff development, and continuous instrumentation evaluation.

Core Functions

• Guide interpretation and appropriateness of laboratory testing and results to physicians, nurses, and other medical personnel.
• Evaluate new procedures and instrumentation for technical feasibility, cost-effectiveness, and clinical application.
• Ensure thorough inservicing of all new procedures and instrumentation.
• Support specialty laboratory staff by reviewing completed work, evaluating performance, assessing competency, and providing guidance as needed.
• Review and validate abnormal test results by correlating data with physiological conditions or specific patient symptoms.
• Develop and maintain expertise in instrumentation and interpretation of clinical data.
• Direct all troubleshooting efforts relating to methodologies, instrumentation, and quality control issues at all testing sites.
• Lead educational activities at each laboratory site and direct medical laboratory scientist staff in appropriate course of action.
• Act as a resource in the development of chemistry-related Individual Quality Control Plans (IQCPs).
• Review regulatory requirements and ensure section preparedness for successful CAP and JCAHO inspections.

Qualifications and Experience

• PhD in Chemistry required.
• Three years of clinical experience, including some supervisory experience preferred.
• Clinical Chemistry expertise including theory of analytic techniques and practical expertise in complex procedures.
• Knowledge of quality control principles and statistical tools.
• Ability to evaluate new procedures from both technical and diagnostic viewpoints.
• Ability to communicate effectively with physicians and provide input on test interpretation.
• Analytical and problem-solving skills.
• Ability to learn new computer and state-of-the-art technologies.

Reporting to R&D, Engineering, and manufacturing leadership, the Biochemist develops and optimizes formulation processes for test kit development spanning in-house R&D, clinical trials, and customer use. Partnering with QA personnel and junior manufacturing staff, this Biochemist enables successful diagnostic product launches by aligning lyophilization, conjugation, and strip assembly components to cGMP and ISO 13485 standards.

Primary Duties

• Align critical product components including lyophilization, chemical formulation, conjugation, and strip assembly to achieve successful launch of robust diagnostic products.
• Optimize manufacturing components, processes, and formulations for performance and cost.
• Participate in day-to-day operations including process improvements, quality testing, inventory management, and labor accountability.
• Develop operating protocols and documents meeting ISO 13485 and cGMP standards.
• Support implementation of automation processes to improve manufacturing throughput.
• Work directly with QA personnel to support ISO 13485 and cGMP certification.
• Assist with developing capacity plans to support production requirements.
• Train junior manufacturing personnel to implement efficient manufacturing workflow.
• Manage equipment specifications, IQ/OQ/PQ, calibration, and preventive maintenance.

Skills and Qualifications

• Bachelor's in Molecular Biology, Biology, or similarly related field.
• 3+ years in an IVD industrial setting.
• Direct knowledge of manufacturing processes, lyophilization, conjugation, and formulation of IVD diagnostic products.
• Direct knowledge of PCR, DNA oligomer quantification, and PCR enzyme.
• Highly motivated, goal and milestone-driven with ability to work independently in a multidisciplinary team environment.
• Good presentation, writing, and communication skills.

Sitting at the intersection of biochemistry and biophysics, the Biochemist delivers SPR experiments and plate-based assays evaluating small molecule binding activity to RAS and related proteins in support of the FNL/NCI RAS Initiative. Operating across a highly collaborative team of chemists, structural biologists, and computational scientists, this Biochemist advances cancer drug discovery through rigorous data collection and informed by the latest findings in the field.

Technical Responsibilities

• Perform SPR experiments to evaluate small molecule binding activity to RAS and related proteins in collaboration with chemists, structural biologists, and computational scientists.
• Conduct plate-based biochemical assays such as alpha and trFRET assays to evaluate activity of small molecule inhibitors.
• Stay informed of the latest findings in biochemical and biophysical assay and cancer drug discovery.
• Work independently within a highly collaborative team environment.
• Document and report experimental results accurately and promptly.

Experience and Qualifications

• Doctorate degree in a field related to biomedical research from an accredited college or university.
• Working knowledge of biochemical and biophysical assays to measure protein-protein and protein-small molecule interactions.
• Experience with SPR to measure protein-small molecule interactions and plate-based protein binding assays.
• Experience with biochemical assays to measure small molecule activity on protein interactions.
• Familiarity with modern protein analytical technologies such as FPLC, Dynamic Light Scattering, and Circular Dichroism.
• Highly collaborative, self-motivated, team-oriented individual with excellent communication skills.
• Must be able to obtain and maintain a security clearance.

A key member of the biopharmaceutical quality function, the Biochemist performs quality testing and data review for in-process and bulk ingredients and finished products, including revising SOPs to maintain compliance. Collaborating across laboratory, regulatory, and safety teams, this Biochemist supports investigations, CAPA processes, and inspection readiness to protect product integrity and patient safety.

Duties

• Test, document, and report quality results of in-process, bulk substance, drug product, stability, utility, and cleaning samples.
• Support investigations according to established procedures and recommend corrective actions.
• Evaluate laboratory SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines.
• Develop or revise laboratory SOPs as required.
• Prepare laboratory reagents, standards, and solutions for test procedures and aid others in test procedures.
• Calibrate or verify laboratory equipment.
• Support regulatory inspections, lab investigations, change controls, and CAPAs.
• Ensure safety requirements are followed when performing lab testing and proactively identify potential unsafe hazards.

Requirements

• Bachelor's degree in a science field.
• At least two years of relevant work experience.
• Working knowledge of cGMP, CFR, and other regulations to assure laboratory compliance.
• Experience with ELISA, PCR, Bioassay, and SPR techniques and troubleshooting.
• Experience with Excel and Word.
• Good communication skills with ability to work well in a team and independently.
• Ability to make sound, compliant decisions when needed.

Impact-driven ADME characterization of new xenobiotics depends on the Biochemist, who conducts in vitro dermal absorption and metabolism studies using human skin, hepatocytes, microsomes, and S9 within a GLP-compliant framework. Based within a collaborative research team and working under the guidance of senior colleagues, this Biochemist enables informed safety and regulatory decisions through precise bioanalytical data generation.

Accountabilities

• Conduct in vitro dermal absorption studies using human skin.
• Conduct in vitro metabolism studies including metabolite profiling and metabolic stability using hepatocytes, microsomes, and S9.
• Prepare buffers and perform basic wet chemistry calculations and serial dilutions.
• Operate instruments including liquid scintillation counters, balances, pipettes, and UV/fluorescence plate readers.
• Write and maintain technical documents including lab SOPs and study protocols.
• Schedule equipment maintenance, order lab supplies, and conduct routine safety inspections.
• Perform work under GLP and other appropriate regulatory guidelines, including safe handling of radioisotopes (14C, 3H).

Education and Experience

• B.S. degree in Biochemistry, Chemistry, or related science field.
• 2 years of relevant experience.
• Ability to understand and perform basic wet chemistry calculations.
• Experience performing bioanalytical analysis using LC/MS/MS analytical instrumentation.
• Computer software skills including Microsoft Word and Excel.
• Strong attention to detail with ability to work independently and with minimal supervision.
• Good written and oral communication skills.

As the Biochemist, this role leads chromatography manufacturing support and facilitates in-house validations from Engineering and Technical Operations through to commercial use, representing Manufacturing within the Validation Process. The Manufacturing team relies on this work to ensure new equipment qualifications, Change Control Projects, and multi-functional validation deliverables are executed on time and to standard.

Scope of Work

• Lead multi-functional team meetings and represent Manufacturing within the Validation Process.
• Utilize project management skills to complete project deliverables including effective communication, leadership, and organizational skills.
• Lead and implement the qualification and validation of new equipment and raw materials within Manufacturing.
• Lead and implement Change Control Projects as appropriate.
• Communicate progress and outcomes to relevant stakeholders throughout the validation lifecycle.

Position Requirements

• Bachelor's degree in Project Management, Biology, Chemistry, Engineering, or other applicable science discipline.
• 3-5 years of work experience.
• Experience in immunoassay diagnostics or immunochemistry preferred.
• Technical background in manufacturing processes and chromatography is a plus.
• Proficient in Microsoft Office programs.
• Strong communication, organizational, and leadership skills with ability to provide guidance to others.

Biochemist produces proteins, conjugates, and antigens for downstream manufacturing, finished good catalog items, and custom orders in accordance with Quidel's Quality System Regulations. The work directly supports production continuity by training junior staff, assisting in rare reagent production, and contributing to validation and investigation activities under moderate supervision.

Key Deliverables

• Perform all duties of Protein Biochemist I with familiarity across most product families and their requirements.
• Assist in the production of critical rare reagents under the direction of management.
• Assist in validation processes for product design and improvement under the direction of management.
• Assist in product investigations for customer complaints and production issues under the direction of management.
• Perform assay analysis, propose assessment of results, and provide testing summaries for inclusion in reports.
• Participate in training of Protein Biochemist I by providing hands-on examples and auxiliary guidance on procedure requirements.

Background and Experience

• Bachelor's degree in Biology, Biochemistry, Chemistry, or other related science field with 2 years of specific laboratory experience outside coursework.
• Strong core competency in biochemistry, microbiology, and protein engineering and purification.
• Mastered skills in single-step antibody purifications, small-scale and single-step conjugations, and hybridoma cell culture.
• Knowledge of methods and techniques to support process improvement and product development with focus on yield improvement and cost reduction.
• Ability to set up custom spreadsheets and analysis templates in data analysis or equipment software for daily examination and trend identification.
• Compliance with FDA, ISO, and export country regulatory requirements.
• Proficient communication with supervisor and cross-functional teams on production progress and key project initiatives.
• Expertise in project organization and time management.
• Ability to work under moderate to minimal supervision.

The Biochemist owns the establishment and leadership of plant metabolite analysis at the Innovation Center in Beijing, developing and validating quantitative methods for seed and product composition across corn, soybean, and other crops. Reporting into the Crop Trait Discovery team and providing scientific leadership to cross-functional groups in plant molecular biology, genetics, and phenotyping, this Biochemist enables the organization to achieve higher performance standards and deliver on R&D accountabilities.

Strategic Responsibilities

• Develop, validate, and implement quantitative methods for evaluation of seed and product composition in corn, soybean, and other crops.
• Provide scientific leadership to the group and to cross-functional teams in plant molecular biology, genetics, physiology, and phenotyping.
• Lead multiple multi-disciplinary projects and programs within and across functions.
• Develop innovative phenotyping methods at the molecular, biochemical, tissue, plant, and population level for corn, soy, cereals, and other key crops.
• Develop and implement changes that enable the organization to deliver on current accountabilities and meet higher performance standards.
• Support wet-lab work of team members to develop proxy assays for key quality traits.
• Seek out, identify, and communicate best practices from internal and external sources of information.

Professional Experience

• PhD in Chemistry, Biochemistry, or Biology.
• 15+ years of experience conducting experiments in wet lab, controlled growth, and field environments.
• 15+ years of experience applying state-of-the-art measurement technologies to characterize plant metabolites.
• Development experience in lab-, bench-, pilot-, and full-scale environments with scale-up and scale-down knowledge.
• Demonstrated ability to implement automation and programming solutions to increase throughput and efficiency of data delivery.
• Demonstrated expertise creating LIMS systems and integrating them with instrumentation to facilitate accurate and reliable data capture.
• Experience with R&D pipelines and constraints associated with material quantities and turnaround times.
• Advanced expertise in analytical chemistry instrumentation and principles.
• Experience in cross-functional and multi-cultural project management.
• Bilingual in Mandarin and English.

Embedded within the Validation and Function group of the Novartis Biologics Center in Cambridge, MA, the Biochemist refines understanding of in vitro effects of protein coding variants derived from genetic and clinical databases spanning hundreds of thousands of human subjects. Working closely with project teams and senior scientists, this Biochemist advances target validation for biologics-based therapies by doubling clinical success through human genetic validation.

Role Responsibilities

• Design and perform experiments related to soluble and membrane protein biochemistry including site-directed mutagenesis, protein expression, liquid chromatography, liposome-based protein purification, Western blotting, and ELISAs.
• Design and execute protein-based stability and functional assays.
• Work collaboratively with project team members and communicate directly to design, execute, and present experimental results.
• Generate hypotheses, troubleshoot issues, and design next experiments with input from senior team members or manager.
• Document results in an electronic laboratory journal and internal databases.
• Contribute to report writing, publications, and working project team meetings.

Minimum Qualifications

• MS in molecular or cell biology, biochemistry, or related field with 1+ year of relevant experience, or BS with 4+ years of relevant experience.
• Proficiency in modern techniques related to protein expression and purification from mammalian and microbial-based host cell systems.
• Ability to use bioinformatics for in silico prediction of variant impact on protein stability and function including conservation analysis and structural modeling.
• Familiarity with large-scale human genetics databases such as UK Biobank and gnomAD.
• Track record of accomplishment in protein biochemistry.
• Strong written and oral communication skills with ability to work collaboratively and independently with strong attention to detail.

Reporting to the Analytical Services team, the Biochemist develops and executes biopharma assays for customer samples while liaising with customers and consultancy-project experts from sample receipt through report delivery. Partnering with global sales, channel partners, and internal stakeholders, this Biochemist strengthens customer relationships and supports GLP standards implementation to grow analytical service capability.

Job Functions

• Provide technical support and advice in the biopharma field to the Analytical Services team and to customers as necessary.
• Liaise with consultancy-project experts to clarify testing requirements, interpret results, and agree on next steps.
• Design and execute appropriate Biopharma Analytical Service assays for customer samples.
• Prepare and check analytical reports in a timely manner and ensure sample information is provided and stored.
• Prepare relevant documentation to support Analytical Service operations including SOPs, protocols, and admin documentation.
• Support the global sales effort with customer meetings, demonstrations, and internal and external training courses.
• Maintain awareness of relevant developments in biopharma analytical science and contribute to safe laboratory operations.

Knowledge Skills and Abilities

• Undergraduate degree in Biochemistry or Biology required; 1-year Experimental Master's degree is a plus.
• 1+ year of experience working in industry, preferably in a pharmaceutical company.
• Experience with HPLC and knowledge of physicochemical drug properties preferred.
• Proficiency with MS Office.
• Excellent written and oral communication skills with strong customer service skills.
• Excellent teamwork, strong attention to detail, and planning and organizational skills.
• Ability to work in a fast-paced environment and manage multiple priorities.

The Biochemist advances structural biology activities on soluble and membrane protein targets and complexes to drive structure-based drug design efforts, performing high-throughput purification of recombinant proteins using affinity, ion exchange, and size exclusion chromatography. Based within a diverse team of scientists and working closely with cross-functional drug discovery colleagues, this Biochemist enables generation of appropriate target proteins that accelerate crystallization and biochemical assay programs.

Day-to-Day Responsibilities

• Perform high-throughput purification of recombinant proteins for structural studies and biochemical assays using standard chromatographic methods and automated parallel processing systems.
• Lyse prokaryotic and eukaryotic cell pellets and clarify lysates by centrifugation.
• Purify proteins by affinity, ion exchange, and size exclusion chromatography.
• Analyze protein purity using SDS-PAGE gel electrophoresis and quantify protein concentration by Bradford assay and UV spectroscopy.
• Enter all experimental data accurately and timely into a LIMS and laboratory notebooks.
• Work closely with cross-functional colleagues and project teams to generate appropriate target proteins for drug discovery.
• Manage storage, retrieval, and shipping of protein samples using Microsoft Excel, barcodes, and LIMS.

Technical Qualifications

• Broad experience with protein biochemistry and hands-on execution of protein purifications.
• Experience in membrane protein biochemistry and use of ultrafiltration and diafiltration tangential flow filtration devices.
• Familiarity with AKTA chromatography systems.
• Proficiency in Microsoft Excel and LIMS platforms.
• Strong interpersonal, written, and verbal communication skills with strong digital literacy.
• Organized and effective at multi-tasking with ability to run several purification experiments simultaneously.
• Attention to detail, ability to keep accurate records, and strong work ethic.
• Flexibility to work in an environment with constantly evolving priorities and timelines.

Biochemist executes formulation and stability studies for vaccine and biotherapeutic candidates at the National Institutes of Health in Gaithersburg, MD, independently generating and analyzing samples using spectroscopic and calorimetric instrumentation. The work directly supports NIH development teams by producing technical reports, coordinating external service providers, and advancing assay development for vaccine and biotherapeutic characterization.

Work Activities

• Execute studies for evaluation and development of stable formulations for vaccine and biotherapeutic candidates in collaboration with development teams.
• Generate samples for analysis independently using standard laboratory techniques including buffer prep, dialysis, and dilution.
• Analyze samples employing spectroscopic, calorimetric, or other instrumentation and collate data to support assay development for vaccine and biotherapeutic characterization.
• Write and review technical reports and protocols documenting formulation, stability, and method development studies.
• Present data in small group and department settings.
• Coordinate formulation and stability studies, oversee external service providers, and manage maintenance and troubleshooting for one or more pieces of laboratory instrumentation.

Education and Experience

• B.S. or M.S. in Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
• 1-2 years of industry, government, or equivalent experience in protein analytics, formulation, or a related field.
• Knowledge of structural properties of proteins and familiarity with classic protein biochemistry sample handling and analysis including buffer preparation, dialysis, and SDS-PAGE.
• Hands-on experience with one or more of the following: UV-visible, fluorescence, Circular Dichroism, or IR spectroscopy, Differential Scanning Calorimetry, or particle characterization techniques.
• Familiarity with data analysis software such as Excel, Prism, or SigmaPlot.
• Proficiency with Microsoft Word and PowerPoint.
• Good written and oral communication skills with the ability to work independently and manage time effectively.

The Biochemist delivers purification of mono, polyclonal, and recombinant antibodies for studies in precision medicine, oncology, immunology, neuroscience, and stem cell research, reporting to a team lead within a biotechnology manufacturing environment. Collaborating across the production team on column chromatography, troubleshooting, and methodology improvement, this Biochemist ensures the highest quality of finalized antibody products.

Operational Focus

• Follow SOPs and batch records for purification of mono, polyclonal, and recombinant antibodies.
• Operate, maintain, and troubleshoot lab equipment from UV monitor to AKTA Pure.
• Prepare buffers and dilutions and perform dialysis, centrifugation, and column chromatography.
• Perform basic math calculations to determine antibody amounts and concentrations.
• Conduct endotoxin tests and assist with troubleshooting purifications.
• Advance multiple projects simultaneously and collaborate with team members to ensure high productivity.
• Accomplish goals under strict timelines with excellent organizational and multitasking skills.

Experience and Qualifications

• Associate's degree in Biochemistry, Chemistry, or related area, Biotech certification.
• 2 years of experience in biotech product development or manufacturing.
• Bachelor of Science in Biology, Chemistry, or related area with less than 1 year of related experience.
• Experience in using UV Monitor and working with conjugated antibodies.
• Experience manufacturing under ISO and GMP environments.
• Demonstrated ability to be detail-oriented, organized, and work well in a group setting.
• Proficient in MS Office, Outlook, and other computer-based software.

Embedded within a GMP manufacturing team covering Bio production, Purifications, Immunochemistry, or Customs, the Biochemist I manufactures product under direct supervision while adhering to GMP and GDP practices and client quality imperatives. Working closely with lead associates and cross-functional department teams, this Biochemist I supports safe, compliant production operations and contributes to client company initiatives within a structured team framework.

Areas of Ownership

• Responsible for the manufacture of product under direct supervision in one of the following areas: Bio production, Purifications, Immunochemistry, or Customs while adhering to GMP and GDP practices and client Quality imperatives.
• Manufacture product following GMP and GDP practices under guidance of lead associate.
• Perform basic lab practices such as pipetting, conductivity and pH measurements.
• Maintain lab equipment and perform laboratory responsibilities such as inventory management and cleaning.
• Support client company and departmental initiatives within a team framework.
• Promote a safe work environment, participate in Environmental Health and Safety programs, and notify supervisor of all observed hazardous conditions or unsafe work practices.

Background and Experience

• Associate's degree with 2 years of manufacturing experience, or 4-5 years of experience in a life science related manufacturing environment.
• Basic knowledge of GMP and GLP practices.
• Conjugation experience and column experience.
• Direct lab experience testing antibodies with experience in pipetting, conductivity, and pH measurements.
• Unit conversion calculations and SAP experience.
• Working knowledge of Word, Excel, PowerPoint, and Visio.
• Effective written and oral communication skills with analytical, technical, organizational, and problem-solving skills.
• Ability to work with direct supervision in a team environment with minimal critical decision making.

As the Biochemist, this role designs and compounds Multichem Control products to desired specifications while coordinating production schedules and monitoring finished goods inventory across a regulated manufacturing environment. The quality and compliance team relies on this work to ensure ongoing product stability, new product introductions, and adherence to ISO 9001, ISO 13485, IMB, and FDA regulatory requirements.

Functions

• Manufacture Multichem Control products to desired specifications through designing and calculating additions for compounding of control products.
• Assist in coordinating schedules and inventory requirements for control production.
• Implement systems to support generation and analysis of product performance data to monitor ongoing performance and stability of control products.
• Assist in troubleshooting product problems and work with Technical Director to resolve, correct, and improve product lines.
• Liaise with sales staff on production requirements regarding analyte composition and targeting in all control products and assist in monitoring inventory of finished goods.
• Provide technical support on introduction of new products and assist in execution of QC testing.
• Ensure adherence to regulatory and GMP requirements.

Qualifications and Experience

• Degree in Biochemistry or equivalent with a good understanding of clinical biochemistry.
• Minimum 2-3 years of experience in a Biotechnology, Pharmaceutical, or Medical Device environment.
• Experience in production operations and quality assurance in an ISO 9001, ISO 13485, IMB, or FDA regulated environment.
• Functional knowledge of interactions between proteins, enzymes, hormones, and peptides in human serum matrices with regards to commutability and stability.
• Proven ability in optimizing production processes.
• Strong project management skills with ability to prioritize multiple tasks and projects.

The Biochemist shapes the expression, purification, and characterization of integral membrane proteins for structural biology and biophysics experiments at Vertex Pharmaceuticals, using affinity, size exclusion, and ion exchange chromatography to deliver high-quality, homogeneous protein. Reporting into the Protein Sciences group and collaborating with research laboratory colleagues, this Biochemist enables structural biology and biophysical programs by ensuring consistent delivery against challenging purification targets.

Delivery Expectations

• Express, purify, and characterize integral membrane proteins for structural biology and biophysical experiments.
• Design and implement protein purification protocols to generate high-quality, homogeneous protein using affinity, size exclusion, and ion exchange chromatography methods.
• Proactively troubleshoot expression and purification of challenging targets to ensure consistent delivery of high-quality protein.
• Characterize stability and homogeneity of purified proteins using techniques such as FPLC, HPLC, SDS-PAGE, and LC-MS.
• Learn new techniques as needed to support the Protein Sciences group.

Skills and Qualifications

• Bachelor's or Master's degree in Biochemistry, Molecular Biology, or a related field with a minimum of 2 years of experience in a research laboratory; industry experience highly desired.
• Proven record and expertise in molecular biology and protein chemistry techniques.
• Demonstrated ability to produce and analyze data and communicate results effectively.
• Excellent organizational and documentation practices.
• Team-oriented with ability to work effectively in a fast-paced, timeline-driven environment.

Reporting to laboratory management, the Biochemist maintains mammalian cell lines and conducts protein, DNA, and RNA purification experiments alongside molecular biology and immunology assays including ELISA and Western Blot in an R&D setting. Partnering with the broader laboratory team, this Biochemist contributes precise, well-documented results that inform ongoing research programs through a high level of independence and rigorous record keeping.

Core Responsibilities

• Maintain mammalian cell lines and conduct experiments with cell lines and tissues using sterile techniques.
• Conduct protein, DNA, and RNA purification and related assays.
• Conduct molecular biology and immunology assays including ELISA, Western Blot, and BCA.
• Keep accurate records in an electronic laboratory notebook.
• Perform lab maintenance, housekeeping, and ordering of lab supplies.
• Utilize Microsoft Office and other software to process and present data.

Education and Experience

• Minimum Bachelor's degree in Biology, Microbiology, Biochemistry, or a related discipline.
• Experience in a molecular biology, cell culture, or microbiology lab strongly preferred.
• Proficiency in mammalian cell culture, tissue processing, and sterile techniques with excellent aseptic technique.
• Proficiency in Microsoft Office and other software preferred.
• Good time management and organizational skills with a high level of independence and effective verbal and written communication.

Sitting at the intersection of protein biochemistry and biologics discovery, the Biochemist creates high-quality proteins through AKTA-based column chromatography for immunizations, crystallography, and in vitro or in vivo antibody applications. Operating across a multidisciplinary biologics discovery team within a project-timeline-driven environment, this Biochemist generates characterized protein samples that advance structure-activity and drug discovery programs.

Key Responsibilities

• Purify proteins using column chromatography including affinity, ion exchange, and size exclusion using AKTA systems from cell cultures (293/CHO).
• Characterize and analyze proteins using standard methods such as SDS-PAGE, CE-SDS, AnSEC, endotoxin, and LC/MS.
• Perform compound management of purified protein samples including aliquoting, labeling, and deposit.
• Perform experiments with strong attention to detail and documentation.
• Accomplish goals under project team timelines while working effectively in a multidisciplinary biologics discovery team.

Required Qualifications

• BS degree with 4+ years of industry experience, or MS degree with 1+ years of industry experience in Biochemistry, Biophysics, Molecular and Cell Biology, or a similar field.
• Independent ability and experience in generation and characterization of high-quality proteins for immunizations, crystallography, or equivalent purposes.
• Strong expertise in antibody purification and characterization for in vitro or in vivo uses.
• Experience and knowledge of molecular biology and expression preferred.
• Excellent time management and organizational skills.
• Excellent written and oral communication skills.

A key member of the Biology Department, the Biochemist executes biochemical screening strategies supporting Entos' oncology drug discovery programs by developing assays, generating structure-activity relationship data, and managing CRO-based screening from target validation through IND submission. Collaborating across internal project teams and external CRO partners, this Biochemist advances a preclinical pipeline of novel small molecule inhibitors through rigorous high-throughput automation and actionable data delivery.

Strategic Initiatives

• Develop relevant assays to inform structure-activity relationship analysis and perform in vitro mechanism of drug action studies.
• Generate data to drive drug discovery decisions and enable project teams to progress from target validation to clinical candidate selection.
• Ensure timely delivery of biochemical data that guides drug discovery strategy.
• Manage biochemical assays at CROs including sample registration, logistics, data communication, presentation, and troubleshooting.
• Lead efforts to leverage outsourced screening capabilities to facilitate timely data delivery to drug discovery projects.
• Communicate scientific strategies effectively in internal and external settings.

Technical Qualifications

• PhD or MS degree in Biochemistry or related field.
• Broad and deep experience in biochemical analysis of small molecule inhibitors or agonists.
• Development and mechanism of action analysis using platforms such as Caliper MSA, AssayQuant, ADP-Glo, Kinase-Glo, Radiometric, Kinome-scan, HTFR/TR-FRET, ITC, DSF, AlphaScreen, and Fluorescence Polarization.
• Proven expertise in assay automation using platforms such as Biomek FX and TECAN.
• Proven experience in high throughput automation and rigorous data analysis to generate high-quality, robust datasets.
• Basic understanding of structure-activity relationships to enable communication with project teams.
• Demonstrated experience writing and following SOPs and performing regimented data QC and uploading to electronic databases.
• Deep experience in oncology small molecule drug discovery with strong scientific and technical expertise.

The Biochemist oversees manufacturing of in-process and intermediate reagents for the Molecular Manufacturing group, maintaining production schedules and performing all processes in accordance with QSOPs and batch records. Based within the Operations facility and reporting to the area Manager, this Biochemist enables finished goods production by managing ERP work orders, troubleshooting equipment, and supporting continuous improvement and CAPA systems.

Accountabilities

• Maintain the production schedule as determined by area management and perform all processes in accordance with required QSOPs and batch records.
• Maintain appropriate inventory status for intermediate reagents, raw materials, and lab supplies.
• Record daily production on batch records, log sheets, and other production documentation.
• Transfer materials and create work orders and associated item lots within the ERP system.
• Troubleshoot and help maintain equipment within the Molecular Manufacturing area.
• Maintain lab notebook for appropriate processes including Maxi Preps and quantifying concentrations.
• Aid in production of validation lots for new products and participate in continuous improvement and CAPA systems.
• Ensure a safe and clean work environment and provide the Manager with information on day-to-day activities within the department.
• Monitor personal daily production, communicate problems to the Manager, and provide assistance across multiple departments to promote a teamwork environment.

Experience and Qualifications

• Bachelor of Science in Biology or other natural science related field with 2-4 years of industry experience or equivalent combination of education and experience.
• Experience with GMP and GLP requirements, FDA and ISO 13485 standards, and other regulatory bodies preferred.
• Technical competence in production, testing, and troubleshooting activities relating to reagents.
• Experience with laboratory techniques such as aseptic methods and dilution preferred.
• Equipment experience with common laboratory instruments including microscopes, pipettes, centrifuges, and balances.
• Computer experience with Microsoft Excel, Microsoft Word, and a records management system.
• Excellent documentation and record keeping skills with basic algebra skills.
• Ability to read, understand, and comply with required work instructions.

The Biochemist advances molecular biology and biochemistry experimentation in target enrichment, whole genome sequencing, and multi-omics sample preparation methodology, performing gel electrophoresis, quantitative PCR, and nucleic acid quantification with support from senior team members. Collaborating with bioinformaticians, chemists, and protein engineers across local and global project teams, this Biochemist generates data that drives important decisions about project goals.

Core Functions

• Perform molecular biology and biochemistry experiments including gel electrophoresis, quantitative PCR, and nucleic acid quantification with the support of senior team members.
• Operate state-of-the-art equipment including Illumina sequencers and liquid handling robotics.
• Communicate and present results to local and global project teams.
• Record and document procedures and results accurately.
• Handle biological hazards in a safe environment.
• Collaborate with scientists including bioinformaticians, chemists, and protein engineers.

Professional Experience

• Bachelor's or advanced degree in a relevant scientific field.
• 4-6 years of laboratory experience in academia, a research institute, or a biotech company.
• Experience in molecular biology and handling of nucleic acids.
• Experience in using liquid handling robotics is desirable.
• Experience in biochemical and biophysical protein characterization is desirable.
• Strong laboratory skills and solid understanding of relevant scientific principles.
• Evidence of ability to follow and implement complex protocols.
• Strong communication, record keeping, and presentation skills.

Reporting to manufacturing leadership, the Biochemist maintains mammalian and insect cell cultures and purifies recombinant proteins and antibodies by affinity chromatography to support production runs across multiple concurrent projects. Partnering with cross-functional departments internally and externally, this Biochemist trains and leads junior team members while ensuring ISO 13485:2016-compliant batch records underpin every production cycle.

Primary Duties

• Maintain mammalian and insect cell cultures and transfect or transduce cells to manage production runs.
• Purify recombinant proteins and antibodies by affinity chromatography.
• Prepare various buffers and reagents for experiments while maintaining general upkeep of the lab.
• Maintain batch records and other documentation in compliance with ISO 13485:2016.
• Plan production runs, harvest and process cultures, and troubleshoot as needed.
• Work effectively both independently and collaboratively in a fast-paced environment across multiple projects.

Qualifications and Experience

• Bachelor's degree in Biology, Biochemistry, Chemistry, or other related area.
• 2+ years of recombinant protein and antibody production experience in a manufacturing setting.
• Ability to culture and maintain mammalian or insect cells.
• Experience in troubleshooting and determining root cause analysis.
• Proven ability to train and lead junior members of the team.
• Demonstrated ability to be detail-oriented, organized, and work well in small work groups.
• Capable of working cross-functionally with other departments and coordinating projects internally and externally.

The Biochemist leads recombinant protein expression, purification, and characterization in support of novel crop protection compound discovery within FMC's Chemical Genomics Group, developing functional assays and molecular analysis tools including metabolite profiling and proteomics. Collaborating internally and externally while managing multiple projects, this Biochemist enables identification of new crop protection leads through target-based methods and cross-functional scientific partnerships.

Engineering Responsibilities

• Express, purify, and characterize recombinant proteins and enzymes for crop protection research.
• Develop functional assays capable of reporting on the efficacy of synthetic small molecule effectors.
• Develop molecular analysis tools to understand mechanisms of new small molecules including metabolite profiling and proteomics.
• Establish target-based methods for efficient discovery of novel crop protection leads.
• Collaborate internally and externally to develop new capabilities and manage multiple projects in a fast-paced research environment.

Technical Qualifications

• PhD in Biochemistry, Biophysics, Enzymology, or a related field with 3+ years of postdoctoral or industrial laboratory experience.
• Demonstrated success in recombinant protein production and assay development; some experience with membrane proteins preferred.
• Experience with multiple biochemical and biophysical assay methods such as UV-Vis, Fluorescence, SPR, thermal shift, and ITC.
• Experience with liquid chromatography-mass spectrometry based techniques for enzyme assays, metabolomic profiling, and proteomic analysis.
• Experience with in silico methods of virtual screening and molecule design preferred.
• Ability to demonstrate strong technical leadership on cross-functional projects and independently acquire necessary technical expertise.

Sitting at the intersection of structural biology and medicinal chemistry, the Biochemist purifies challenging GPCR and membrane protein complexes and uses biochemical, biophysical, and computational approaches to generate high-quality reagents for crystallization and CryoEM studies. Operating across multidisciplinary teams of structural biologists, biophysicists, and medicinal chemists at Lilly Research Laboratories, this Biochemist advances drug discovery for innovative projects targeting GPCRs and membrane proteins.

Ownership Areas

• Purify challenging GPCR and membrane protein complexes as well as soluble protein complexes for structural biology and drug discovery efforts.
• Use state-of-the-art biochemical, biophysical, and computational approaches to accelerate generation of high-quality reagents for crystallization and CryoEM studies.
• Partner closely with structural biologists, biophysicists, protein biochemists, and medicinal chemists.
• Develop integrative approaches to address specific project needs and challenges.
• Collaborate on multidisciplinary teams designing novel therapeutics and present scientific data in support of drug discovery projects.

Required Qualifications

• PhD degree, or BS or MS with 10+ years of experience, in Structural Biology, Biophysics, Biochemistry, Chemistry, or other relevant field.
• Prior industry experience with a strong publication record highly preferred.
• Experience in both X-ray crystallography and cryo-EM is advantageous.
• Comprehensive experience in membrane protein manipulation in detergent-free environments such as nanodiscs and amphipols is a plus.
• Familiarity with other biophysical methods such as MS, bioNMR, SPR, and BLI is helpful.
• Flexibility to work in an environment with constantly evolving priorities with strong interpersonal, written, and verbal communication and problem-solving skills.
• Strong capability to collaborate with scientists in multiple fields.

A key member of the R&D team, the Biochemist designs enzyme libraries and builds multi-enzyme pathways by applying biochemistry, enzymology, and molecular biology knowledge to develop and validate enzyme assay methods and commercial formulations. Collaborating across projects and operating ELN and automated purification systems, this Biochemist enables delivery of high-throughput enzyme characterization and immobilized biocatalyst solutions for biotechnology applications.

Key Responsibilities

• Apply biochemistry, enzymology, and molecular biology knowledge to study enzymes and design enzyme libraries.
• Build and optimize multi-enzyme pathways.
• Develop, conduct, and validate enzyme assay methods and prepare assay SOPs and protocols.
• Conduct high-throughput enzyme characterization and assay.
• Design, study, and develop commercial enzyme formulations and immobilized biocatalysts.
• Operate purification and enzyme activity assay automated systems.
• Record and document all stages of R&D work and operate lab information and knowledge management systems such as ELN.
• Prepare reports and presentations and provide enzymology perspectives and support to projects.

Qualifications and Experience

• PhD in Enzymology, Biochemistry, Biotechnology, or related field with 3+ years of industry experience, or MS with 6+ years of significant experience.
• Applied knowledge in structural and mechanistic enzymology, enzyme kinetics, formulation, immobilization, bioorganic chemistry, and organic synthesis.
• Experience with enzymatic activity assay methodology development and validation.
• Understanding of modern molecular biology and enzyme engineering techniques and protein expression optimization methods.
• Practical experience in metabolic pathways, protein design, directed evolution, automation, and bioinformatics is a plus.
• Ability to utilize bioinformatics for novel enzyme discovery and screening preferred.

The Biochemist delivers laboratory support for vaccine production and development by utilizing HPLC, SDS-PAGE, ELISA, Gel Electrophoresis, and UV-VIS to perform quality and compliance testing within a pharmaceutical manufacturing environment. The work directly supports regulatory compliance and process improvement through deviation investigations, OOS analysis, and assay validation activities.

Day-to-Day Responsibilities

• Utilize HPLC, SDS-PAGE, ELISA, Gel Electrophoresis, and UV-VIS skills to assist in the production and development of vaccines.
• Assist with endotoxin testing within the lab.
• Support process improvement projects including standardization and execution of test methods and assay validation and qualification.
• Perform deviation and OOS investigations and carry out experiments in support of these investigations.
• Ensure compliance with regulations, guidelines, and procedures.

Education and Experience

• Bachelor's degree in Biochemistry or related field.
• Minimum 2 years of experience in development or manufacturing of pharmaceutical products.
• Hands-on experience with HPLC using Empower and Gel Electrophoresis.
• Technical writing experience preferred.
• Fluency in English and knowledge of other languages.