ASSISTANT SCIENTIST JOB DESCRIPTION

GLP and GMP compliance frameworks govern every experiment an Assistant Scientist runs, not as a formality, but as the regulatory backbone that makes study data defensible in an IND or product submission. When those records slip, entire studies become unusable, and submission timelines collapse. Assistant Scientists in biotech and pharmaceutical settings own the execution layer: running validated bioanalytical and biochemical assays, maintaining GxP-compliant documentation, and supporting nonclinical and clinical programs from sample receipt through final report. They operate within regulated research or manufacturing environments, typically reporting to a Senior Scientist or Study Director. 

As the Assistant Scientist, you are accountable for the accurate execution and documentation of laboratory assays supporting product development, regulatory submissions, and GLP or GMP studies across discovery, stability, and release workflows. You work within a cross-functional research team spanning analytical, bioanalytical, and process development groups, with scope that may extend to method validation support and Study Director coverage on assigned GLP protocols.

Career Impact: Hands-on ownership of GLP study execution and method validation builds a technical record that opens pathways to Senior Scientist and Study Director roles within regulated biotech and pharma environments. 

Business Impact: The assay data you generate directly supports IND filings, product release decisions, and nonclinical study outcomes, outputs that determine whether a candidate program advances or stalls. 

Growth Opportunity: Exposure to BSL-2 containment work, flow cytometry, and GMP manufacturing environments expands your technical portfolio into areas that command increasing market value as pipelines mature.

• Execute GLP and GMP laboratory assays, including bioanalytical, spectroscopic, chromatographic, and immunological methods to support product release, stability, and nonclinical studies. 
• Develop, optimize, and validate analytical or bioanalytical methods to meet study plan specifications and regulatory standards. 
• Prepare biological samples, stock solutions, reference standards, and QC materials in compliance with applicable study protocols. 
• Document all laboratory work, experimental observations, and data in GxP-compliant notebooks and electronic systems with accuracy and traceability. 
• Serve as Study Director on assigned GLP studies, including protocol authorship, execution oversight, and final report preparation. 
• Monitor critical process parameters and instrument performance, performing routine preventive maintenance and calibration to ensure data integrity. 
• Coordinate with Sample Management, Study Leads, and cross-functional teams to schedule sample receipt, analysis, and timely delivery of results. 
• Review and contribute to SOPs, analytical method summaries, and technical reports to ensure procedural currency and compliance.

• Bachelor's degree in Chemistry, Biology, Biochemistry, or a related life sciences field, or equivalent work experience. 
• 3 or more years of laboratory experience in a GLP- or GMP-regulated environment, with demonstrated proficiency in bioanalytical or analytical assay execution. 
• Working knowledge of Good Laboratory Practice and Good Manufacturing Practice regulations and their application to study documentation and sample handling. 
• Ability to prepare, aliquot, and process biological matrices including plasma, cell culture media, or blood products following established safety and procedural standards. 
• Demonstrated competency in laboratory record-keeping, including accurate notebook documentation, SOP adherence, and data traceability practices. 
• Experience performing routine laboratory maintenance including pipette verification, instrument calibration, and glassware management. 
• Strong attention to detail with the ability to manage multiple concurrent study assignments under deadline pressure. 
• Effective verbal and written communication skills sufficient to present data and findings to study teams and project stakeholders.

• Master's degree in a life sciences discipline with prior industrial or contract research laboratory experience. 
• Hands-on experience with flow cytometry, viral enumeration assays, or BSL-2 containment procedures. 
• Familiarity with LIMS platforms for sample scheduling, worklist management, and bioanalytical data entry. 
• Experience serving as Study Director or co-investigator on GLP studies, including protocol development and final report authorship. 

• GLP study completion rate, measured as the percentage of assigned studies delivered on schedule without protocol deviations requiring rejection. 
• Method validation acceptance rate, tracking the proportion of assay validation runs that meet pre-defined acceptance criteria on first attempt. 
• Documentation error rate per audit cycle, reflecting compliance with GxP recordkeeping standards across notebooks and electronic systems. 
• Sample processing turnaround time against study plan commitments, measured in hours from receipt to analytical result. 
• Out-of-specification investigation closure time, tracking how quickly identified anomalies are documented and resolved per SOP. 
• Typical tools: Chromatography data systems (commonly Waters Empower or Agilent OpenLAB); LIMS platforms (commonly LabVantage or Watson LIMS); laboratory productivity suites (commonly Microsoft Office or Google Workspace). 

• Base Salary Range: $52,000 – $72,000 annually, varying by seniority and region
• Bonus: 5–8% annual performance bonus, common in pharma and CRO settings
• Equity: Uncommon at this level; RSU grants occasionally offered at larger biotech firms
• Health Benefits: Medical, dental, and vision coverage; employer contribution standard
• PTO: 15–20 days annually plus recognized federal holidays
• Common Perks: Lab safety gear allowance, tuition reimbursement, professional development budget for scientific conferences

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

Employment contingent on successful completion of a background check and, where applicable, a drug screening consistent with laboratory safety standards. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations for applicants with disabilities are available upon request throughout the hiring process. Candidates must be authorized to work in the United States. 

The Assistant Scientist delivers assigned projects across formula development, stability evaluation, and margin improvement initiatives, working with Consumer Innovation Centers, global supply chain teams, and cross-functional partners including Quality, Regulatory, and Legal. Supporting both regional bundle implementation and technology transfer across manufacturing sites, this role shapes the product innovation pipeline and directly enables the division's Funding the Growth and simplification objectives.

Key Responsibilities

• Deliver assigned projects working with Consumer Innovation Centers, go-to-market teams, and Global Supply Chain.
• Support knowledge and technology transfer in manufacturing sites across regions and work as part of divisional Funding the Growth and simplification teams to develop and implement Margin Improvement Projects including formula, raw materials and process improvements.
• Interact with business partners such as Consumer Innovation Centers, Technology Innovation, local marketing, Quality, Regulatory, Environmental Affairs, Occupational Health and Safety (EOHS), Technology Insights, Legal, Supply Chain and Product Development.
• Submit and follow up on invention records and research reports.
• Working under general supervision, develop new technical leads, processes, methods, and services by applying the fundamentals of technology for assigned projects.
• Support the conceptualization, design, management, and data analysis of projects, including implementing new technologies and conducting clinical trials.
• Develop formulas, conduct stability evaluations, and communicate results with relevant functions.
• Deliver timely results against assigned grid projects.
• Develop, validate, and implement assigned regional and local bundles.
• Adapt and implement assigned global bundles through line extensions.
• Validate formula and process robustness and key release specifications with local raw materials and manufacturing.
• Implement divisional simplification and margin improvement projects.
• Suggest improvements to manufacturing processes, review supplier documentation and raw materials, and support experimental manufacturing orders, production start-ups, and resolution of quality issues.
• Provide local connections to consumer insights, competitive activity, and external visibility to regional scientific communities.
• Communicate learnings via research reports, invention records, patents, and presentations to internal business partners and senior management.
• Compile data required to ensure efficient technology transfer and anticipate, identify, and communicate potential issues.
• Ensure accurate documentation, including notebooks, standard operating procedures, claims dossiers, and bundle books.

Required Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, Materials Science, Biotechnology, or Cosmetic Science required.
• Master's degree in Chemistry, Chemical Engineering, Biochemistry, Materials Science, Biotechnology, or Cosmetic Science preferred.
• 1–3 years of relevant laboratory experience required with a Bachelor's degree
• 1 year preferred with a Master's degree.
• 1–2 years of experience in the consumer goods industry in R&D or manufacturing.
• Advanced proficiency in English.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) or Google Suite (Docs, Slides, Sheets).
• Experience with PDM and SAP.

Embedded within the Bacteriology department, the Assistant Scientist supports diagnosticians in identifying plant pathogenic bacteria across plant clinic samples and latent surveillance work, including screening for high-priority pathogens such as Xylella fastidiosa and Erwinia amylovora. Working closely with the broader plants programme team, this role builds the department's diagnostic capacity and directly safeguards the integrity of accredited detection and surveillance outputs.

Core Functions

• Assist diagnosticians in the identification of plant pathogenic bacteria on samples arriving in the plant clinic.
• Process latent surveillance samples, including screening river water for brown rot and plant samples for Xylella fastidiosa and Erwinia amylovora.
• Book in, core, and process ring rot and brown rot potato survey samples.
• Prepare and mail ring rot and brown rot coring kits.
• Prepare and label consumables used in bacterial survey work.
• Manage stock control and ordering of consumables used in diagnostic work.
• Assist in testing commercial potato samples for soft rot loading levels.
• Process seed samples to aid detection of specified plant pathogenic bacteria.
• Assist with immunofluorescence microscopy work.
• Assist in routine molecular screening work, including PCR, TaqMan, and sequencing preparation.
• Assist in the validation and implementation of improvements in diagnostic and detection methods.
• Help clean and maintain routinely used facilities and equipment.
• Carry out work in accordance with ISO 17025 and ISO 9001 quality accreditation standards.
• Carry out result entry through an electronic database as required.
• Provide support for other work in the plant's programme as required.

Qualifications & Experience

• 5 GCSEs at Grade C or above, including English and Maths or Science, or equivalent experience.
• Practical laboratory experience in molecular biology or plant pathology is desirable.
• Experience working with quarantine pathogens is desirable.
• Experience working to accredited standards such as ISO 17025 and ISO 9001 is desirable.
• Meticulous adherence to protocols and standard operating procedures.
• Ability to provide good customer service and prioritise work in a busy environment.
• Excellent team-working skills with a strong sense of responsibility for the quality of work.
• Excellent written and verbal communication skills with the ability to work in an organised manner and meet deadlines while maintaining high standards.
• Good IT skills, particularly using databases and Microsoft applications, including Outlook, Excel, and Word.
• Interest in plants and plant diseases is desirable.

Reporting to the scientific and study lead teams, the Assistant Scientist supports bioanalytical operations by preparing biological samples, conducting method development and validation, and maintaining GLP-compliant documentation across all assigned project work. Partnering with sample management and LC/MS/MS teams, this role ensures the accuracy and continuity of data workflows that underpin study delivery and regulatory compliance.

Primary Duties

• Prepare biological samples for quantitative and qualitative analysis.
• Assist with method development and validation.
• Prepare stock and working solutions, standards, and QC samples.
• Make and record observations, perform calculations, and collect and prepare data for evaluation.
• Document and comply with all project work according to GLP processes and procedures, as applicable.
• Perform pipette maintenance and verification, and other laboratory maintenance as required.
• Assist in maintaining adequate supplies and housekeeping standards for the work area.
• Interface with sample management to request and return study samples.
• Use the LIMS system to schedule samples, set up and edit worklists, and manage bioanalytical data.
• Clean glassware and sustain Six Sigma standards in wet laboratory areas.
• Perform peer review of wet laboratory preparations.
• Provide clear communication with scientific, study lead, and LC/MS/MS teams.

Skills & Qualifications

• High school diploma with 2 years of relevant laboratory experience.
• Bachelor's degree in Biology, Chemistry, or a related field, or an equivalent combination of education and training.
• Experience in a GLP analytical laboratory.
• Familiarity with Good Laboratory Practices (GLP).
• Basic knowledge of mathematics and chemistry.
• Basic mechanical skills.
• Familiarity with a variety of pipettes.
• Basic computer skills, including word processing, spreadsheets, and network navigation.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability and willingness to work with potentially hazardous chemicals and instrumentation.
• Ability to work with known infectious materials, radioactive materials, and analytes with a high occupational exposure band rating.

Sitting at the intersection of virology and immunological assay development, the Assistant Scientist executes experiments across BSL-2+ environments, including viral enumeration assays, T cell proliferation assays, and GLP studies involving blood products such as plasma, platelets, and RBC. Operating across independent and team-based research settings, this role advances product claims and regulatory submissions while mentoring junior personnel and serving as study director on GLP studies.

Duties

• Execute experiments, make observations, analyze data, and interpret results, either independently or as a team member, including experiments for product claims and regulatory submissions.
• Work with various viruses in BSL-2+ environments.
• Prepare and manipulate various blood products, including plasma, platelets, and RBC.
• Develop, optimize, and qualify or validate viral enumeration assays.
• Perform and analyze T cell proliferation assays utilizing flow cytometry.
• Participate in the validation of new methods.
• Analyze data and results for research experiments and GLP studies.
• Perform and appropriately document GLP and notebook studies in an accurate and timely manner.
• Prepare final reports, protocols, study plans, and other required documentation.
• Maintain laboratory instruments and serve as study director on GLP studies.
• Mentor or guide other personnel as needed.

Experience & Qualifications

• Bachelor's degree or equivalent certification in a scientific discipline.
• Minimum of 5 years of relevant experience, or a Master's degree with a minimum of 2 years of relevant experience.
• Experience culturing mammalian cell lines.
• Experience with flow cytometry, working with viruses, or working with human blood products is highly desirable.
• Experience working in a GLP or other regulated environment.
• Proficiency in writing reports and publications.
• Solid understanding of GLP and GMP requirements.
• Understanding of laboratory procedures, equipment, and computerized data handling.
• Strong attention to detail and accuracy with good analytical, problem-solving, and troubleshooting skills.
• Ability to work independently and in a team environment, with flexibility to adapt to changing priorities.
• Good communication skills, encompassing verbal, written, interpersonal, and listening abilities.
• Good time management skills, including scheduling, timelines, and task prioritization.

A key member of the production and laboratory team, the Assistant Scientist owns campaign documentation, in-process analytical method development, and process optimization for fermentation operations at production scale, including work with GC, HPLC, and bio-analyser instrumentation. Collaborating across engineering, quality, and manufacturing functions, this role enables cost, quality, and safety improvements that support efficient scale-up and technology transfer.

What You'll Do

• Prepare production and laboratory documentation, consolidate and interpret production data such as DeltaV historical trends, mass balance, and in-process analysis, and summarize findings in campaign reports.
• Perform SAP inventory transactions related to assigned production campaigns.
• Assess process variability and establish critical process parameters.
• Develop in-process analytical methods, establish specifications for monitoring production processes, and provide operator training for in-process laboratory analyses.
• Conduct chemical and microbiological laboratory procedures independently, covering planning, execution, documentation, and conclusion.
• Start up production-scale fermentation inoculums in the 20-L fermentor.
• Propose and develop process optimization to improve cost, quality, and safety.
• Assist in receiving process transfers by replicating processes at laboratory scale and serving as the local technical expert for production scale-up.
• Develop and maintain chemical and microbiological procedures and laboratory SOPs, and participate in assigned process reviews and maintain production operating procedures.
• Maintain and repair assigned laboratory instruments, including GC, HPLC, and bio-analyser.
• Purchase and maintain inventory of laboratory consumables.
• Maintain technical knowledge of all relevant chemical processes and equipment and develop expertise in departmental technologies.

Education & Experience

• Bachelor's or Master's degree in a Biological, Chemical, or Chemical Engineering Science.
• Minimum 3 years of experience in a laboratory environment.
• Basic knowledge of microbiology, biotechnology, biochemistry, or chemistry.
• Basic knowledge of gas and liquid chromatography analytical techniques.
• Understanding of aseptic techniques, media preparation, cryo-preservation, and sterilization.
• Operational knowledge of general laboratory apparatus and instruments.
• Knowledge of SAP is a plus.
• Highly motivated, well-organized, and able to work independently and safely while multitasking to meet production deadlines.

Continuous monitoring of ongoing experiments, data collection, and media preparation under the supervision of the Senior Scientist depends on the Assistant Scientist, who supports key technical aspects of inter-divisional projects spanning method development, validation, and procedural compliance. Based within a collaborative team setting, this role ensures the quality of practical laboratory work and the integrity of scientific documentation that enables project progression and reporting to internal partners.

Day-to-Day Responsibilities

• Perform laboratory activities in support of key experiments and ensure the execution of high-quality practical work and method development.
• Identify problems, analyze possible causes, and suggest improvements in methods, techniques, and equipment.
• Participate in data interpretation and assist in the incremental improvement of current procedures and protocols.
• Participate in the development and validation of new scientific methods and procedures where appropriate.
• Document procedures, maintain a lab notebook, deliver concise reports on finished projects, and organize their distribution as needed.
• Ensure compliance with all health, safety, and environmental procedures and proactively propose improvements.
• Maintain a clean and well-organized laboratory workspace.
• Use all internal tools for data collection, recording, and administration independently and efficiently.
• Provide administrative support to the technical team.

Background & Experience

• Bachelor's degree in Chemistry, Biology, Microbiology, Molecular Biology, Food Science, or a relevant field from an accredited college or university.
• Technical knowledge in biology and bioanalysis.
• Excellent record-keeping skills with strong attention to detail.
• Able to work on multiple projects simultaneously and adapt to a dynamic work environment, including changing priorities and quick-turnaround projects.
• Effective verbal and written communication skills with the ability to present ideas understandably to both technical and non-technical audiences.
• Able to work in a team and on a flexible schedule.

As the Assistant Scientist, this role supports the strategic direction of R&D pipeline projects by applying expertise in pharmaceutical dosage form formulation, translational science, and product development activities under supervisory guidance. The R&D function relies on this work to advance novel science addressing consumer and HCP unmet needs, maintaining standards and procedures that strengthen the organization's product development capabilities.

Scope of Work

• Collaborate with commercial partners to understand consumer and HCP unmet needs for continued pipeline development, including concept creation.
• Provide input to the strategic direction of projects, initiatives, and scientific disciplines in support of organizational strategies.
• Apply diversified expertise in technical principles and assess the implications of product and technology outcomes on the broader function and organization.
• Advance novel science and develop products that are translational to applicable need states, offering superior efficacy, safety, or consumer experience.
• Maintain and create standards, guidelines, and procedures for diverse R&D activities.

Requirements

• Bachelor's degree required, with preference for a science- or technical-related field such as Chemical Engineering, Pharmacy, Chemistry, or Biology.
• 0–24 months of relevant experience.
• Previous experience in industry via co-op, internship, or employment is preferred.
• Ability to perform limited formulation of pharmaceutical dosage forms.
• Ability to perform product development and process development activities with direction from a supervisor.
• Basic understanding of GMPs, GLPs, ICH, CFR, and regulatory requirements.
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint, with strong oral and written communication skills.
• Detail-oriented, highly organized, and able to manage multiple tasks and work both independently and as part of a team.

Assistant Scientist leads laboratory and field study support across sample extraction, analytical instrumentation operation, including HPLC, and GLP-compliant data entry and results reporting under the direction of study directors. The work directly supports aquatic science research and environmental study delivery by maintaining accurate written and computer records and ensuring all procedures meet required quality standards.

Job Functions

• Maintain responsibility for laboratory facilities, including daily equipment checks, instrument maintenance, and general laboratory housekeeping.
• Conduct work in compliance with the Good Laboratory Practice system and standard operating procedures.
• Perform laboratory procedures using standard laboratory equipment.
• Assist others in all aspects of laboratory and field studies in compliance with relevant study plans and methods.
• Conduct sample extraction and clean-up using a variety of wet chemistry techniques.
• Operate analytical instrumentation, such as HPLC.
• Maintain written and computer records and perform data entry and checking for study directors.
• Calculate and report results.

Position Requirements

• Science-related qualifications or equivalent experience, with laboratory experience preferred.
• Experience or exposure to working within a quality system is desirable.
• Experience or exposure to aquatic science or working with fish is desirable.
• Ability to keep clear and accurate written records of experimental work to a high standard.
• Practical IT skills in Microsoft Word and Excel.
• Ability to work within a team and independently under supervision.
• Ability to organise, prioritise, and complete work to required standards and tight deadlines.

The Assistant Scientist produces formula designs and coating system developments for microwavable products, translating consumer insights and customer requirements into new product concepts through independent design and supplier collaboration. Supporting cross-functional teams in product development and plant operations, this role advances the company's new product pipeline by delivering high-quality outputs within time-sensitive project timelines.

Accountabilities

• Support new product and concept development based on strategic and customer requirements.
• Manage and assist all new product procedures, delivering high quality, customer satisfaction, and continuous performance improvement.
• Translate consumer insights into formula design with execution agility and creativity.
• Design and update product formulas independently based on customer requirements.
• Develop and apply new coating systems and technologies suitable for microwavable products, including emulsion coating systems used as batter or glaze.
• Communicate with current suppliers to fulfill product development projects and introduce new suppliers with cost-saving and emerging technology considerations.
• Assist with preparation of raw meat and accessories according to product formula, complete pretreatment, and provide product standards according to the process.
• Screen and introduce new suppliers and accessory materials suitable for microwavable products.
• Record and process data relating to product development activities.

Professional Experience

• Bachelor's degree or above in Food Science, Food Engineering, or a related field.
• CET-4 certification.
• At least 2–3 years of experience in new product development or operations.
• Prior experience in product development and plant operations.
• Experience with innovation and ideation processes.
• Project management experience in a time-sensitive environment.
• Strong innovation and new product development capabilities.
• Strong communication and cross-functional communication skills.

Embedded within the Culture Development R&D team, the Assistant Scientist advances product and technology development through independent research on microbial cultures for the fermented food industry, applying microbiological methods and food fermentation approaches in support of business-directed projects. Working closely with upstream research, culture applications, and manufacturing teams across local and global functions, this role develops new products and foundational knowledge that directly enable the organization's culture development strategy.

Key Deliverables

• Conduct product development research on microbial cultures for the fermented food industry.
• Independently conduct research on business-directed projects through the application of microbiological methods and food fermentation approaches to develop new products and technology.
• Develop project plans in conjunction with the group manager.
• Independently execute research plans, including experimental design and documentation.
• Interpret results and formulate future research actions or alternative technical solutions.
• Communicate research findings internally and externally.
• Serve as a technical expert, resource, and mentor in food microbiology, food fermentation, and functionality analysis.

Minimum Qualifications

• Master's degree or above in Microbiology, Food Science, or a related field.
• Minimum of 5 years of industrial or equivalent research experience in bacterial physiology, application, or starter culture development.
• Experience in fermented food functionality analysis, including texture and flavor, especially in fresh fermented dairy products.
• Demonstrated ability to independently design, manage, and perform multi-task projects to a successful result.
• Experience in leading research projects.
• Excellent oral and written communication skills in both Chinese and English for presenting scientific concepts and results to internal and external audiences.
• Experience in molecular biology is a plus.
• Experience in basic biochemical analysis, including HPLC and GC, is a plus.

Reporting to the scientific leadership team, the Assistant Scientist refines NGS-related sample preparation workflows and contributes to product validation, quality control testing, and technical documentation across contract research and product development projects. Partnering with customers, manufacturing, and laboratory personnel, this role strengthens the organization's molecular biology and immunology capabilities and ensures the delivery of reproducible, high-standard results to internal and external clients.

Work Activities

• Participate in next-generation sequencing-related sample preparation and tests, including PCR and library construction, and produce competent, reproducible results to a high technical standard.
• Contribute to product improvements and perform quality control testing, including organizing and performing product validation by following appropriate laboratory and technical procedures.
• Assist in the preparation of documentation for products, including technical reports, summaries, protocols, and data analyses, and ensure product knowledge is kept up to date.
• Liaise between customers and manufacturing for entry-level issues regarding antibodies.
• Verify and prepare contract research project deliverables for clients.
• Support laboratory and production operations, including training laboratory personnel and providing related guidance.

Technical Qualifications

• Master's degree in the life sciences with at least 1 year of additional research laboratory experience.
• Bachelor's degree in the life sciences with 6–9 years of research laboratory experience.
• Background in molecular biology and immunology with experience in ELISA, PCR, DNA sequencing, and the application of biochemical reagents and kits in life sciences research.
• Laboratory experience in multiple major applications, particularly PCR and next-generation sequencing.
• Epigenetic research experience.
• Experienced and comfortable using computers, with working knowledge of Excel, Word, and Outlook.
• Excellent verbal and written communication skills.
• Outstanding organisation and time-management skills with the ability to multitask.
• Strong troubleshooting and problem-solving skills.
• Friendly, positive, self-motivated, and a collaborative team player.

Sitting at the intersection of analytical chemistry and biopharmaceutical product development, the Assistant Scientist develops and qualifies or validates bioanalytical assays using spectroscopic, chromatographic, and immunological approaches to support GMP- and GLP-compliant testing for product release, stability studies, and nonclinical and clinical programs. Operating across discovery, formulation, and regulatory support functions, this role enables product characterization and licensure by maintaining laboratory records, performing preventative maintenance, and upholding all GxP documentation and safety requirements.

Operational Focus

• Develop and qualify or validate analytical or bioanalytical assays using spectroscopic, chromatographic, electrophoretic, immunological, in-vitro bioassay, or related novel approaches to support sample analysis for various functions.
• Perform GMP- or GLP-compliant testing to support product release and stability or nonclinical and clinical studies.
• Perform testing to support product discovery, proof-of-concept studies, and candidate selection.
• Characterize products and impurities to support process and product development, licensure, and product investigations.
• Characterize and develop drug product formulations.
• Execute experiment protocols, receive and test samples, and document laboratory work consistent with GxP requirements.
• Maintain laboratory records and inventory for supplies and reagents.
• Perform preventative maintenance on laboratory equipment and maintain a clean and sanitary work area in accordance with standard laboratory practice.
• Adhere to all effective SOPs and safety requirements.

Knowledge, Skills & Abilities

• University degree or technical diploma in Chemistry, Biology, or a related field.
• Training in GLP regulations is required before participating in a GLP study.
• Familiarity with a wide variety of analytical, laboratory, and scientific methodologies and techniques.
• Competence in laboratory safety and generally accepted laboratory practice, including maintaining adequate written laboratory records.
• Basic knowledge of Microsoft Office, including Word and Excel.
• Knowledge of laboratory techniques and safety precautions, including WHMIS and biohazard safety awareness.
• Ability to communicate and articulate information in both written and verbal forms.
• Strong organisational and interpersonal skills with the ability to work collaboratively with others.