ANALYTICAL SCIENTIST JOB DESCRIPTION

Analytical method development is precise work. When it is done poorly, drug substance release is delayed, stability data loses regulatory standing, and ICH submissions stall. The Analytical Scientist is the laboratory professional who prevents those outcomes, owning method development, validation, and transfer activities for APIs, excipients, and finished pharmaceutical products within a GMP-regulated environment. Work spans both small molecule and biologic modalities, interfacing with Quality, Regulatory, Formulations, and contract research organizations. The role demands scientific rigor and a working command of compendial testing standards.

As the Analytical Scientist, you will develop, validate, and transfer analytical methods that directly determine the release and stability standing of drug substances and finished pharmaceutical products under GMP and ICH regulatory frameworks. You will operate within a cross-functional laboratory team, collaborating with Quality Control, Regulatory Affairs, and external CRO partners across multiple product programs.

Career Impact: Analytical Scientists who build validated method portfolios across small molecule and biologic programs gain standing in the pharmaceutical development market that transfers across innovator, generic, and CDMO organizations.

Business Impact: Reliable release and stability data depend entirely on the accuracy of the methods this role owns — without validated, transfer-ready methods, product batches cannot be released and regulatory submissions cannot advance.

Growth Opportunity: Depth in ICH stability protocols, GMP documentation, and cross-modal analytical techniques positions the Analytical Scientist for Senior Scientist and Analytical Development Lead roles in pharmaceutical R and D.

• Develop and validate analytical methods for API, excipients, and finished pharmaceutical products to meet GMP and ICH regulatory requirements.
• Execute release and stability testing of drug substances and finished products in conformance with compendial and internally developed test methods.
• Design and implement method transfer protocols to Quality Control laboratories and external CRO partners, ensuring successful completion within project timelines.
• Perform in-process analysis of samples from cell culture, fermentation, or solid and liquid dose manufacturing processes to support ongoing product development.
• Review and approve analytical data, technical protocols, and regulatory documentation to maintain data integrity and documentation compliance.
• Monitor and troubleshoot chromatographic and spectroscopic instrumentation to sustain laboratory readiness and minimize downtime.
• Mentor junior analysts in method execution, interpretation of validation studies, and GMP documentation practices.
• Collaborate with Formulations, Quality Assurance, and Regulatory Affairs teams to define specifications and resolve analytical issues across assigned projects.

• Bachelor's degree in Analytical Chemistry, Biochemistry, Chemical Engineering, or a related discipline, or equivalent work experience.
• 5 or more years of analytical method development and validation experience in a GMP-regulated pharmaceutical or biotech environment, with demonstrated expertise in release and stability testing.
• Working knowledge of FDA regulations, ICH guidelines, and cGMP requirements as applied to analytical chemistry within drug development.
• Proficiency in chromatographic and spectroscopic analytical techniques including HPLC, GC, UV-Vis, and mass spectrometry-based methods.
• Demonstrated ability to develop, execute, and document method validation and transfer protocols in compliance with regulatory standards.
• Strong written and verbal communication skills, with ability to prepare technical reports and present data clearly to cross-functional audiences.
• Proven organizational ability to manage multiple projects simultaneously in a matrix environment and escalate issues in a timely manner.

• MS or PhD in Analytical Chemistry, Biochemistry, or a related discipline, with experience in both small molecule and large molecule characterization techniques.
• Experience with biologic-specific analytical methods including ELISA, capillary electrophoresis, or antibody characterization for drug substance programs.
• Familiarity with ICH stability study design and execution for respiratory, solid oral dose, or injectable pharmaceutical products.
• Knowledge of statistical tools such as design of experiments and data trend analysis as applied to analytical method development.

• Method validation cycle time, measured in days from initiation to approved protocol completion.
• Out-of-specification investigation rate per batch released, reflecting analytical method robustness and execution accuracy.
• Method transfer success rate across receiving laboratories or CRO partners without requiring revalidation.
• Stability study adherence rate, measuring on-time completion of ICH timepoint testing relative to protocol schedule.
• Documentation deviation count per quarter, tracking GMP compliance in laboratory records and analytical reports.
• Typical tools: Chromatography data systems (commonly Empower or equivalent); laboratory information management systems (commonly LIMS-based platforms)

• Base Salary Range: $75,000 to $105,000 annually, depending on experience and education level
• Bonus: 5 to 10 percent annual performance-based bonus, common in pharmaceutical settings
• Equity: stock options or RSUs available at mid-size biotech and publicly traded pharmaceutical employers
• Health Benefits: medical, dental, and vision coverage, typically employer-subsidized from date of hire
• PTO: 15 to 20 days annually, plus company holidays and sick leave
• Common Perks: Professional development funding, tuition reimbursement, laboratory safety training, and certification support

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

Accommodation requests for applicants with disabilities may be submitted at any stage of the recruitment process, and reasonable accommodations will be provided in accordance with applicable law. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected under federal, state, or local law. Employment in this role is contingent upon successful completion of a background check. Candidates must be authorized to work in the United States without requiring sponsorship now or in the future.

The Analytical Scientist owns the execution of technical strategies in analytical chemistry within a region or category, leading method development and validation activities while interfacing with partners in Formulations and Quality across the GSK network. The role delivers innovation by applying HPLC and GC expertise and builds scientific contribution through documentation, troubleshooting, and cross-functional communication.

Key Responsibilities

• Execute technical strategies in analytical chemistry within a region or category.
• Apply technical skills and functional knowledge to projects and assignments.
• Develop novel hypotheses and apply new ideas and knowledge to projects.
• Interface with internal and external partners such as Formulations and Quality.
• Assist in developing approaches to solving moderate scientific problems.
• Produce effective presentations and tailor written messages to appropriate audiences.
• Lead method development and validation activities with supervision.
• Follow documentation procedures and resolve documentation issues in a timely manner.
• Troubleshoot moderately difficult instrumentation issues.

Required Qualifications

• MS in Analytical Chemistry with a minimum of 5 years of experience, or BS with a minimum of 7 years of relevant experience.
• 5-7 years of experience in analytical sciences, preferably in Rx, OTC, or consumer products industry.
• Proven ability to assist in developing scientifically sound and robust methods for release and stability testing.
• Knowledge of cGMP requirements related to analytical chemistry within product development.
• Strong organizational ability and comfort with complexity and ambiguity in a matrix organization.
• Good communication skills in a matrix environment, with ability to convey problems clearly and concisely.

Embedded within the Sales, Marketing, Research, and Engineering environment, the Analytical Scientist develops new analytical methods and leads capability improvements for specialty gas phase products in Danbury, CT. Working closely with global internal and external customers, the role advances product quality by establishing detection limits, maintaining instrumentation, and delivering results through reports and training.

Core Functions

• Safely perform gas phase analysis to support current products, new product development, and customer requests.
• Develop new analytical methods for measuring trace and assay impurities in gas phase products.
• Improve existing analytical methods continuously to meet growing customer demand.
• Establish detection limits, accuracy, precision, and stability for analytical methods via MSA methodology.
• Support analytical development projects on a global scale for internal and external customer requirements.
• Design, set up, and execute experiments and communicate results via reports and presentations.
• Write and maintain Standard Operating Procedures, Work Instructions, reports, and audits including MSA and V and Q documentation.
• Maintain lab practices and documentation per ISO 17025 and 9001 requirements.
• Train team members on analytical instruments, methods, and SOPs.
• Maintain and troubleshoot instrumentation including FTIR, GC, CRDS, and RGA.

Qualifications and Experience

• BS in Chemistry or Chemical Engineering.
• Certifications or training in Six Sigma, Semi, or ISO are a plus.
• 4-5 years of working experience in a laboratory, or total working experience of 6 years or more.
• Experience in analytical instrument operation, data analysis, and method development.
• Experience interfacing with customers on technical issue resolution is a plus.
• Ability to perform SCBA or prior training and certification.
• Team player attitude with a desire for excellence and continuous improvement.
• Flexible with ability to rapidly respond to new situations and perform multiple tasks.

Reporting to the senior analytical science team, the Analytical Scientist initiates analytical testing for the characterization of biopharmaceuticals, vaccines, and polyclonal and monoclonal antibodies in a lab-based setting. Partnering with clinical and cross-functional groups, the role shapes data quality and project development by executing ELISA, cell-based bioassays, and serological assays.

Primary Duties

• Initiate analytical testing for characterization of biopharmaceuticals and vaccines.
• Support senior analytical scientists in developing analytical methods including ELISA and cell-based bioassays.
• Purify and characterize polyclonal and monoclonal antibodies.
• Perform a variety of serological and potency assays to provide clinical support to assigned projects.
• Prepare accurate and detailed documents of experimental designs, protocols, procedures, presentations, and reports.
• Provide cross-functional sharing of data to aid in project development.
• Analyze and interpret scientific data.

Skills and Qualifications

• BS or BA in chemistry, biochemistry, biological sciences, veterinary science, or related discipline with a minimum of 5 years of demonstrated work experience.
• MS in chemistry, biochemistry, biological sciences, or veterinary science with 2 years of experience in analytical development, preferably in an industrial research setting, is preferred.
• Thorough understanding of biochemistry and immunology with proven ability to develop analytical assays.
• Demonstrated experience in ELISA development.
• Experience with ELISA assays and cell culture.
• Knowledge of automated workstation equipment such as Biomek 4000, Biomek NXp, and plate washer, and HPLC or CGE is desirable.
• Working knowledge of antibody purification and sterile laboratory technique for cell culture.
• Strong computer, scientific, and organizational skills with excellent attention to detail.
• Ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.

Sitting at the intersection of process development and analytical quality assurance, the Analytical Scientist establishes and maintains in-process analytical methods for cell culture and microbial fermentation samples within the Upstream Process Sciences Group. Operating across geographies and internal maintenance teams, the role ensures data integrity, equipment functionality, and staff capability in support of large-molecule biologic product quality.

Duties

• Collaborate with colleagues across geographies to ensure an aligned strategic approach toward developing in-process analytical methods for product quality analysis.
• Establish analytical methods for in-process analysis of samples from cell culture and microbial fermentation processes.
• Ensure all methods are fit for intended use through development, optimization, and application of fit-for-purpose criteria.
• Support the development of high throughput sample purification methods to enable sample analysis.
• Maintain and improve quality systems to ensure sound data integrity principles and documentation practices.
• Provide routine in-process analysis and training in analytical methods to other staff members.
• Ensure maintenance and functionality of all analytical equipment in collaboration with internal maintenance teams.

Experience and Qualifications

• PhD in Biochemical Engineering, cellular biology, biochemistry, or related discipline with several years of industrial experience, or equivalent.
• Experience in method development and method validation in a GMP environment is preferred.
• Proven aptitude for laboratory work with practical experience in HPLC, UPLC, and other equipment for product quality analysis of large biologic molecules.
• Experience with Empower software and electronic lab notebooks is preferred.
• Knowledge of high throughput purification methods using Tecan platforms.
• Ability to troubleshoot technical issues using rational thought processes and respond in a controlled manner.
• Ability to interpret and assess data, draw conclusions critically, and propose future work.

A key member of the Product Team, the Analytical Scientist builds and applies analytical capabilities to identify, isolate, and quantify flavour and aroma molecules that enhance pork belly and bacon cultivated meat products. Collaborating across cell scientists, food scientists, and external testing houses, the role delivers improvements to flavour profiles, product specifications, and regulatory compliance through innovative method development.

Key Deliverables

• Build analytical capabilities by outsourcing to external testing houses and managing close working relationships with them.
• Work closely with cell scientists to achieve high-quality pork belly and bacon products with improved meat flavour profiles.
• Develop and apply new methods to enhance key characteristics such as flavour, mouthfeel, aftertaste, and tenderness.
• Plan and implement analytical methods for the identification, isolation, and quantification of flavour and aroma molecules.
• Generate and review SOPs for complex methods including existing and tailored analytical procedures.
• Conduct characterisation of ingredients and components such as flavour compounds, proteins, fats, nutrients, and colours.
• Conduct quantitative analysis and report on product specifications including nutritional profiling, regulatory clearance, and shelf-life longevity.
• Design experiments and transfer knowledge and data between cell teams and food scientists to improve product formulations.
• Support the creation of new product recipes by advising on experiments and providing expertise in flavour molecule characterisation.
• Stay current with innovation and novel developments in flavour and analytical sciences.

Background and Experience

• Appropriate qualification in Chemistry or a related discipline.
• Professional membership such as the Royal Society of Chemistry is a plus.
• Relevant experience in analytical chemistry and flavours, particularly in meat flavours within the alternative protein sector.
• Experience with GC and MS and HPLC and a strong understanding of state-of-the-art analytical methods.
• Extensive chemistry expertise with experience in isolating flavour compounds and molecules.
• Good understanding of the commercial and manufacturing implications of raw material selection.
• Ability to develop a comprehensive understanding of complex biological processes and cell biology techniques.
• Excellent analytical, organisational, and multi-tasking skills with an innovative mindset.
• Fluent in English, both written and spoken.

Advanced process control across CMC depends on the Analytical Scientist, who leads spectroscopy-based PAT development using FTIR, NIR, Raman, UV, and NMR as in-line and online methods for intermediates, API, and drug products. Based within a multi-disciplinary team spanning Process Chemistry, Analytical Development, and Drug Product Development, the role delivers chemometric models and innovation projects that enable next-generation process understanding.

Strategic Responsibilities

• Lead spectroscopy-based process analytical technology development such as FTIR, NIR, Raman, UV, and NMR as in-line and online methods for intermediates, API, and drug products.
• Apply chemometrics tools to develop chemometric models using spectroscopic data for real-time in-process control.
• Support orthogonal quantitative and offline analytics.
• Support autonomous method developments and model generation using PAT methodologies for synthetic molecules and modality smart applications.
• Work closely with a multi-disciplinary team from Process Chemistry, Analytical Development, and Drug Product Development functions.
• Lead or support targeted innovation and development projects ensuring timely delivery of results.
• Evaluate new analytical technologies to support advanced process control.

Technical Qualifications

• PhD in Analytical Sciences or related discipline with a minimum of 3-5 years of relevant postdoctoral or industry experience, or MS with 6-8 years, or BS with 8-10 years of relevant industry experience.
• Expertise in spectroscopy technologies such as FTIR, NIR, Raman, UV, and NMR and their in-line and online use.
• Expertise in chemometrics tools such as Unscrambler, Matlab, PLS Toolbox, or SIMCA for multivariate analysis and model calibration.
• Experience in off-line analytical method development including chromatographic and orthogonal quantitative methods is preferred.
• Knowledge in analytical methodologies for modality smart applications is advantageous.
• Ability to discuss and understand process chemistry, chemical engineering, and formulation processes.
• Proven ability to collaborate and influence key stakeholders and external partners.
• Excellence in communication, including presenting at meetings, publishing in peer-reviewed journals, and training cross-functional members.

As the Analytical Scientist, this role validates new analytical methods with minimal supervision and serves as a technical resource for Quality Control, Quality Assurance, and International Business within a GMP-regulated pharmaceutical or nutraceutical environment. The Analytical Chemistry team relies on this work to ensure the timely release of raw materials, finished products, and stability samples while maintaining full compliance with FDA and ICH guidelines.

Areas of Ownership

• Validate new analytical methods with minimum to no supervision and provide technical support to Quality Control, Quality Assurance, and International Business.
• Design and execute method transfer protocols for timely product release by the QC department.
• Assess testing methodologies and evaluate testing results from contract laboratories.
• Prepare, review, and approve technical documentation in a timely manner.
• Maintain current knowledge of latest technological and scientific trends and serve as an analytical science resource for the group.
• Mentor and train chemists in the proper execution and interpretation of validation studies.
• Assist with routine testing of raw materials, stability samples, finished products, and out-of-specification investigations.
• Communicate effectively with other departments and function within a team environment.

Education and Experience

• Bachelor's degree with 7 years of experience in validation of analytical methods for nutraceuticals and or pharmaceutical samples in a GMP environment, or Master's degree with a minimum of 3 years of technical experience.
• Degree in analytical chemistry, biochemistry, chemical engineering, or related fields is strongly preferred.
• Thorough working knowledge of FDA and ICH guidelines and experience implementing GLP and GMP adherence in pharmaceutical or nutritional supplement environments.
• Proficient in laboratory instrumentation such as FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, and HPTLC.
• Proficient in Empower Software and other laboratory software used in QC environments for chromatographic and spectroscopic methods.
• Knowledge of statistical techniques such as data trend analysis and design of experiments is highly desirable.
• Demonstrated aptitude to function in a dynamic and fast-paced environment.

Analytical Scientist delivers comprehensive analytical support across the full workflow from intermediate and product specification definition through in-process and QC analysis, with primary focus on NMR spectroscopy for organometallic catalyst development in Cambridge. The work directly supports development and manufacturing teams, QA, Product Managers, and external suppliers by advancing method development and ensuring equipment reliability.

Role Responsibilities

• Provide high-quality analytical support from definition of intermediates and product specifications to in-process and QC analysis.
• Prepare and analyse analytical samples.
• Provide high-calibre NMR expertise for routine and QC analysis, identification and quantification of impurities, and in-process analysis.
• Support chromatographic analytical techniques including HPLC, UPLC, GC, and MS method development and qualitative and quantitative analysis.
• Develop LC, GC, SFC, and NMR analytical methods for QC analysis of intermediates and products.
• Write procedures and technical documentation and promote quality and compliance actively.
• Ensure adequate maintenance of assigned analytical equipment and coordinate engineer visits.

Knowledge Skills and Abilities

• BSc or equivalent in Chemistry or a related scientific discipline, or equivalent industrial experience.
• Extensive knowledge and experience of 1H-NMR and 13C-NMR with knowledge or experience of HPLC, GC, MS, SFC, polarimetry, and KF is advantageous.
• Strong trouble-shooting skills with ability to implement innovative and practical solutions.
• Effective communicator with excellent verbal and written skills, able to convey technical information to a diverse audience.
• Attention to detail with excellent analytical, reporting, and presentation skills.
• Ability to foster productive and inspiring working relationships with peers and across the organisation.

The Analytical Scientist owns bench-level chemical and physical product analyses supporting new product development, plant improvements, and customer requests for a leading specialty ingredient solutions producer. The role delivers results across chromatography, thermal analysis, physical testing, and elemental analysis equipment while ensuring full compliance with safety policies and accurate data reporting to the technology team.

What You'll Do

• Operate and maintain analytical equipment including validations and calibration.
• Follow experimental procedures accurately and work safely in a laboratory environment with appropriate PPE.
• Perform hands-on benchtop analysis such as titrations, pH, conductivity, solution preparation, and dilutions.
• Carry out routine data analysis using analytical software and Excel.
• Present data generated to the technology team.
• Comply with all safety policies, practices, and procedures.

Minimum Qualifications

• Bachelor's or Master's degree in a science is preferred, or Associate's degree with significant relevant experience.
• At least 3 years of experience operating and maintaining analytical equipment.
• Experience with chromatography such as IC, LC, GC, and or HPLC is highly desirable.
• Experience with ICP-OES, thermal methods, XRD, USP and FCC monograph methods, and physical testing methods is desirable.
• Proficiency in Microsoft Office Programs including Excel, Word, and PowerPoint.
• Very good verbal and written communications with strong presentation skills.

Embedded within the Biologics Analytical Research and Development department, the Analytical Scientist executes daily laboratory activities including drug substance release, stability testing, and characterization of biologic products under GMP and GDP standards. Working closely with CROs and cross-functional teams across multiple sites, the role advances method validation and transfer programs while supporting new facility start-up operations.

Day-to-Day Responsibilities

• Support equipment qualification, SOP and work instruction authoring and review, and lab and process workflow establishment during facility start-up.
• Execute analytical method validations and transfers among different sites and between internal teams and CROs, and write technical protocols and reports.
• Execute analytical testing of drug substance release, stability, and characterization for biologics under GMP and GDP.
• Support equipment maintenance, calibration, and qualification work.
• Prepare analytical methods, SOPs, and other documents as required.
• Train new analysts and work in accordance with applicable safety, health, and environmental regulations.

Professional Experience

• MS in analytical chemistry, biochemistry, or related field, or BA with a minimum of 3 years of experience in the pharmaceutical industry.
• Experience with analytical method qualification and transfers.
• Experience with UPLC, HPLC, Capillary Electrophoresis, Mass Spectrometry, or other large molecule characterization techniques.
• Strong oral and written communication skills.
• Ability to work in a team environment with cross-functional interactions.

Reporting to process research and development leadership, the Senior Analytical Scientist acts as Analytical Lead on customer projects, taking personal responsibility for the quality, integrity, and delivery of science while developing LC and GC-MS methods for small molecule APIs and intermediates. Partnering with multidisciplinary PR and D colleagues, the role accelerates client timelines and strengthens process understanding through digital tools, problem-solving, and laboratory administration.

Leadership Responsibilities

• Act as Analytical Lead on customer projects, taking personal responsibility for quality, integrity, communication, and delivery of science, and maintaining strong operational relationships with customers.
• Develop analytical methods for small molecule API and intermediates such as LC and GC-MS and novel solutions that accelerate process research and development.
• Apply digital tools and approaches to deliver fast and efficient process understanding for clients.
• Perform analytical problem solving and troubleshooting as one team with other members of process research and development.
• Act as Laboratory Administrator.

Qualifications and Experience

• BSc in Chemistry or a related subject with significant experience in analytical chemistry.
• Broad experience in analytical science with expertise applied to the development of pharmaceutical products.
• Proven ability to develop scientifically sound and robust methods of analysis using HPLC, GC, and other related techniques.
• Experience in Labware LIMS and Shimadzu Labsolutions software.
• Ability to recognise atypical data in chromatographic and spectroscopic results and resolve those issues.
• An appreciation of or expertise in synthetic chemistry, physical organic chemistry, and or catalysis is advantageous.
• Well-developed data management and visualisation skills with good knowledge of applicable standards and HSSE.

A key member of the analytical project team, the Analytical Scientist designs, performs, and documents experiments that drive method development and validation for excipient, API, and respiratory finished products in a GMP environment. Collaborating across all involved partners as the key analytical contact, the role defines and supervises ICH stability studies and specifications that enable compliant respiratory product development.

Scope of Work

• Design, plan, perform, and document scientific experiments and analyse and interpret results to drive analytical method development and validation for excipient, API.
• Respiratory finished products in a GMP environment.
• Define, supervise, and report ICH stability studies for API and respiratory finished products.
• Act as key contact for all analytical issues within assigned projects and ensure proper communication with all involved partners.
• Define and present specifications for packaging material, excipient, API, and finished products.
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Position Requirements

• Degree in a technical or scientific subject, ideally chemistry or pharmacy, or minimum 5 years of experience in Respiratory Analytical Laboratory testing.
• Experience in development functions, preferably in the pharmaceutical industry.
• Strong knowledge of GMP and regulatory guidelines.
• Good understanding of analytical methods and technologies for respiratory product development.
• Independent way of working with excellent team player skills.

Sitting at the intersection of analytical science and commercial manufacturing, the Senior Analytical Scientist leads technical expertise in characterisation technologies supporting solid and liquid oral dose product development, reformulation, and tech transfer within Pfizer's Small Molecule Organisation. Operating across Quality, Regulatory, network Analytical groups, and third-party partners, the role shapes strategic direction, champions new technologies, and ensures laboratory compliance with health, safety, and environmental regulations.

Ownership Areas

• Manage activities associated with analytical support for process development, reformulation programs, and commercial manufacturing technical support.
• Coordinate characterisation of API, excipients, solid oral dose and liquid intermediates, finished products, nitrosamine, and TiO2 reformulation.
• Provide technical subject matter expertise to Quality, Regulatory, and site operation groups during investigations, tech transfers, regulatory submissions, and new process introductions.
• Represent the team in cross-functional teams supporting commercial and Tech Transfer products.
• Identify and champion implementation of technical programs related to improving methods, laboratory operations, and new technologies for in-process, characterisation, and release testing.
• Participate with Analytical Sciences Leadership in long-term strategic planning to support process development and reformulation programs.
• Represent the Analytical Sciences team at inter-company meetings, third-party partner meetings, and regulatory and scientific industry meetings.
• Develop, implement, and maintain internal training programs for the Small Molecule Organisation.
• Collaborate with the Quality Control team to ensure all Analytical laboratories comply with Health and Safety and Environmental regulations.

Education and Experience

• Bachelor's degree in Analytical Chemistry, pharmaceutical, or allied sciences, or postgraduate MSc or PhD in a relevant field.
• 7 or more years of experience.
• Expertise in spectroscopy and chromatography including LC-MS, MS, NIR, Raman, UV-vis, HPLC, GC, and XRD, with knowledge of microbiology and drug stability studies.
• Experience in all aspects of analytical development and product characterisation for solid oral and liquid formulations.
• Experience in analytical method development, qualification, and validation activities.
• Strong working knowledge of Quality, GMP, ICH, and compliance systems of the pharmaceutical industry.
• Experience in regulatory dossier compilation and developing CMC responses.
• Proficient with problem-solving, risk analysis, and statistical tools.

The Analytical Scientist delivers routine chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples, participating in test method validation under strict GMP, GLP, and SOP compliance. The role supports a quality-regulated pharmaceutical environment by maintaining instrumentation, accurately documenting results, and applying HPLC, GC, LC-MS, and dissolution techniques.

Performance Expectations

• Conduct routine chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples by internally developed and compendial test methods.
• Verify and process analytical data and record and report results in accordance with prescribed lab procedures and systems.
• Participate in the validation of test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution.
• Maintain and troubleshoot analytical instrumentation as needed.
• Maintain and organise work area, instrumentation, and testing materials.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.

Skills and Qualifications

• Bachelor's degree in physical science, preferably in Chemistry or Biology, or equivalent combinations of education, training, and relevant work experience.
• Preferably 1-2 years of experience performing chemical tests with chromatographic, spectroscopic, or analytical techniques.
• Good knowledge of qualitative and quantitative chemical analysis and analytical instrumental technologies.
• Good understanding of quality and regulatory requirements in the pharmaceutical industry including GMPs and descriptive organic chemistry.
• Good proficiency with HPLC, GC, LC and MS, and Dissolution techniques.
• Ability to read, analyse, and interpret technical procedures and governmental regulations, and write standard operating procedures and policy manuals.
• Good interpersonal and communication skills, both oral and written.
• Good problem-solving skills and logical approach to solving scientific problems.

As the Analytical Scientist, this role applies advanced NMR methodologies and develops experimental plans to deliver high-quality, data-driven analytical solutions across multidisciplinary research and business technology platforms at the Experimental Station in Wilmington, Delaware. The broader research team relies on this work to advance omics capability, mentor junior scientists, and maintain a safe laboratory in support of both current and emerging programs.

Key Responsibilities

• Apply advanced NMR methodologies to support new and current research and business technology platforms.
• Develop, implement, and perform sample preparation of a broad variety of novel materials.
• Design NMR experimental plans and develop methods that produce timely, high-quality, and data-driven solutions to contribute to research and business program success.
• Collaborate with multidisciplinary analytical and project teams to provide analytical solutions to complex problems.
• Summarise and communicate results in discussions, presentations to project teams, and formal reports.
• Advance NMR offerings by implementing new NMR technologies identified from literature, conferences, and vendor interactions.
• Mentor junior colleagues and collaborate with peers in a team-based environment focused on skill development and professional growth.
• Maintain a safe laboratory and participate in audits and documentation preparation.

Required Qualifications

• PhD in Chemistry, Analytical Chemistry, or Biochemistry with 3 or more years of hands-on experience in solution NMR spectroscopy, industrial experience preferred.
• Experience with protein dynamics and omics approaches, specifically metabolomics and or proteomics, is preferred.
• Knowledge of theoretical aspects of NMR and experimental design with demonstrated experience in parameter optimisation for data collection and processing.
• Hands-on skills in parameter optimisation for Bruker NMR Spectrometers and Topspin software, with experience in new pulse sequences and or solid-state NMR as a plus.
• Knowledge in complementary analytical methodologies such as MS, HPLC, and SEC is a plus.
• Ability to manage multiple concurrent projects and changing priorities.
• Demonstrated written and oral communication skills with ability to promote a collaborative environment.

Embedded within the Chemistry discovery and development team, the Analytical Scientist performs LC-MS characterisation of ADCs, antibodies, and small molecule drugs using techniques spanning intact mass analysis, peptide mapping, PTM profiling, and native MS. Working closely with protein engineers, chemists, and biologists, the role refines LC-MS and HPLC capabilities, integrates emerging technologies, and supports laboratory infrastructure to advance therapeutic development.

Core Responsibilities

• Identify metabolites of ADC from in vivo or in vitro samples with LC-MS technology.
• Characterise ADC and antibody using HPLC methodology including SEC, HIC, IEX, and RP, and perform method development.
• Prepare samples from various sources including purified protein products and biological matrices such as plasma, serum, and tissues.
• Present written and oral reports to multidisciplinary teams and enter all data into electronic laboratory notebooks daily.
• Identify and integrate technologies that improve LC-MS and HPLC analysis capabilities by working with teammates, collaborators, and vendors.
• Contribute to laboratory build-out and upkeep by maintaining shared equipment and developing processes for improving workflow efficiency.

Technical Qualifications

• PhD in Chemistry, Biochemistry, or a relevant scientific discipline with 1 or more year of postdoctoral or industry experience, or Master's with 3 or more years of industry experience.
• Technical expertise in LC-MS analysis of proteins or small molecules including protein characterisation, bioanalytical quantitation, or proteomics.
• Hands-on experience in sample preparation such as deglycosylation, reduction, and digestion, LC-MS operation, basic maintenance, and HPLC techniques.
• Knowledge of extraction and enrichment techniques such as Affinity Capture, SPE, and Protein Precipitation, and experience with CE-SDS, cIEF, DLS, DSC, and SDS-PAGE is advantageous.
• Strong problem-solving and troubleshooting skills with a track record of innovation and scientific rigor.
• Good verbal and written communication skills with enthusiasm for collaborating with multidisciplinary teams.

The Senior Analytical Scientist produces LC-MS and LC-MS-MS assays and quality control outputs in direct support of Oncology R and D drug discovery programs, working with high-potency compounds in glovebox conditions. The work directly supports compound purification, data interpretation, and timely reporting aligned with AstraZeneca safety, environmental, and Code of Conduct policies.

Executive Functions

• Support Oncology R and D drug discovery programs by accurately weighing and solubilising high potency compounds in a glovebox for analyses.
• Develop analytical assays such as LC-MS and LC-MS-MS methods and conduct LC-MS quality control and HRMS data analysis and reporting.
• Collect, analyse, and interpret data, recognise aberrant results, and run follow-up experiments.
• Deliver quality results efficiently and prepare summaries of work for presentations and reports.
• Assist in the chromatographic purification of compounds.
• Stay up to date with innovations in analytical chemistry and advances in instrumentation.
• Act in accordance with all company policies on personnel, safety, health, environment, best laboratory practice, and Code of Conduct.

Qualifications and Experience

• PhD or MS with 3 or more years of experience in analytical chemistry, chemistry, or a related field.
• Experience running LCMS single-quad, triple quad, and high-resolution MS instrumentation.
• Experience in developing and qualifying reverse-phase and HILIC assays, and with chiral and achiral separations.
• Experience troubleshooting HPLC, UHPLC, and MS instrumentation and performing basic repairs.
• Experience with Waters and Agilent hardware and MassLynx and MassHunter software.
• Experience with glovebox techniques such as weighing and solubilising compounds, and analysing compounds in biological fluids.
• Excellent written and oral communication skills.
• Strong multi-tasking, time management, and organisational skills with strong interpersonal skills.

A key member of the global Lonza analytical network, the Analytical Scientist executes laboratory work supporting analytical testing of antibodies and therapeutic recombinant proteins using capillary electrophoresis, HPLC, UPLC, spectrophotometry, and ELISAs. Collaborating across QC, QA, and global project teams in Singapore and beyond, the role coordinates multiple projects and ensures outstanding customer communication throughout product stability and reference standard activities.

Accountabilities

• Execute laboratory work supporting analytical testing on antibodies and other therapeutic recombinant proteins using techniques including capillary electrophoresis, HPLC and UPLC, spectrophotometry, and ELISAs.
• Collaborate within functional analytical teams by contributing to analytical Product Stability and Reference Standard activities, method validation studies, and Process Analytics.
• Contribute to customer projects by generating and interpreting scientific data from experimental work.
• Coordinate multiple projects and ensure timely delivery of project work stages as part of a site and global project team.
• Facilitate communication between other departments in Singapore and across the global Lonza network.
• Deliver high-quality communication to ensure an outstanding customer experience.

Background and Experience

• Degree in a relevant Science field or equivalent.
• Practical laboratory experience in analytical testing for antibodies or proteins.
• Understanding of theory and application of protein production, purification, and analysis.
• Experience working within a formal Quality Management System such as cGxP and ISO.
• Excellent problem-solving and analytical skills.
• Excellent communication skills, both verbal and written, and strong team working skills.

Analytical Scientist performs routine and non-routine laboratory experiments with supervision, supporting multiple projects simultaneously within a highly matrixed R and D analytical environment. Success in the position means designing, executing, interpreting, and reporting technical data in full conformance with applicable GxP regulations while troubleshooting experimental procedures and maintaining equipment independently.

Work Activities

• Perform routine lab duties and design and execute non-routine experiments with supervision.
• Perform all work in conformance with applicable regulations and in a safe manner.
• Conduct routine maintenance of laboratory equipment and design, execute, interpret, and complete projects in a timely manner.
• Work in a highly matrixed environment and support multiple projects simultaneously.
• Troubleshoot experimental procedures independently and prepare technical reports as needed.

Experience and Qualifications

• Master's degree in a scientific discipline, or Bachelor's degree with 3 or more years of experience in a related scientific discipline.
• Industry experience with GxP regulations is preferred.
• Knowledge and experience in chromatographic techniques and conducting analytical experiments.
• Knowledge and experience in Waters Empower software is preferred.
• Practical familiarity with Excel and PowerPoint.
• Demonstrated written and verbal communication skills.
• Good understanding of established SOPs with ability to plan, conduct, evaluate, interpret, and report technical data.