ANALYTICAL ASSOCIATE JOB DESCRIPTION

A batch held for stability testing cannot ship until its data clears, and that clock starts the moment an Analytical Associate runs the assay. The role sits inside the quality and manufacturing support function of a GMP facility, executing release, stability, and characterization testing for drug substances and finished products. Method validation and transfer between sites, and sometimes between the company and external CROs, fall to this position rather than to QC inspection staff downstream. Deadlines tie directly to product release timelines, so testing throughput here affects when product can move to market.

The mandate of the Analytical Associate is to generate and document analytical data that proves a product meets its specifications before release. Working within a GMP laboratory, the associate reports to a Supervisor or Scientist and coordinates with manufacturing on testing schedules tied to release deadlines.

Career Impact: GMP method validation and transfer experience is a credential pharmaceutical employers screen for when filling QC and validation openings.

Business Impact: Accurate release and stability testing determines whether a batch of biologics or finished product can legally ship to patients on schedule.

Growth Opportunity: Associates who handle cross-site or CRO method transfers typically move toward Senior Associate or Validation Scientist roles with broader project ownership.

• Execute release, stability, and characterization testing for drug substances and finished products under GMP and GDP.
• Perform method validations and transfers across sites, including transfers to external CROs.
• Calibrate and maintain analytical instruments to support ongoing testing schedules.
• Author SOPs and method documentation to support manufacturing and release timelines.
• Review analytical data generated during testing to confirm compliance with specifications.
• Coordinate testing schedules with manufacturing to meet release deadlines.
• Support equipment qualification activities during laboratory or facility start-up phases.

• Bachelor's degree in analytical chemistry, biochemistry, or a related field, or equivalent work experience.
• 1 or more years of analytical testing experience in the pharmaceutical industry, with GMP exposure.
• Hands on experience with chromatography techniques such as HPLC or UPLC.
• Working knowledge of analytical instrumentation qualification procedures.
• Strong oral and written communication skills for technical documentation.
• Ability to work cross functionally with manufacturing and quality teams.
• Familiarity with method validation and transfer protocols.

• Advanced degree such as an MSc or PhD in a chemistry related discipline.
• Experience with mass spectrometry or capillary electrophoresis for large molecule characterization.
• Prior experience transferring methods to or from a contract research organization.
• Exposure to biologics testing in addition to small molecule products.

• On time release testing rate, reflecting how reliably batches clear for shipment on schedule.
• Method validation cycle time, measuring how quickly a transferred method becomes usable.
• Deviation rate per testing batch, tracking documentation and execution accuracy.
• Calibration compliance rate, showing whether instruments stay within qualified testing windows.
• Typical tools: Chromatography systems (commonly HPLC or UPLC); Laboratory information management systems (commonly LIMS).

• Base Salary Range: 55,000 to 75,000 dollars annually.
• Bonus: Small annual performance bonus, typically 3 to 6 percent.
• Equity: Rarely offered at this level.
• Health Benefits: Standard medical, dental, and vision coverage.
• PTO: 15 to 20 days annually, plus standard holidays.
• Common Perks: Lab safety training, tuition assistance for science coursework.

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

Employment in this role is contingent on successful completion of a background check, given the regulated nature of GMP laboratory work. Reasonable accommodations are available upon request for applicants and employees with disabilities. All qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, disability, or any other characteristic protected under federal, state, or local law. Candidates must be authorized to work in the United States.

The Analytical Associate Scientist owns method validations and transfers between sites and CROs, supporting drug substance release, stability, and characterization testing for biologics under GMP and GDP. Reporting to the Supervisor, the role contributes to equipment qualification, SOP authoring, and laboratory workflow establishment within a new laboratory facility.

Key Responsibilities

• Participate in the start-up of operations within the new laboratory facility which will include support of equipment qualification, documentation generation such as SOP's, Work instructions authoring and review as well as contributing to lab and process work flow establishment.
• Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
• Ability to execute testing schedules and adhere to deadlines.
• Execution of analytical method validations and transfers among different sites, and between the company and CROs.
• Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP and GDP.
• Support equipment maintenance, calibration and qualification work.
• Preparation of analytical methods, SOPs and other documents as required.
• Other analytical activities in consultation with the Supervisor.
• Works in accordance with applicable internal company regulations safety, health and environmental protection.

Required Qualifications

• BSc in analytical chemistry, biochemistry or related field or BA with a minimum of 1-2 years of experience in the Pharmaceutical Industry.
• An advance degree (MSc or PhD) qualification is desirable.
• Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, Mass Spectrometry or other large molecule characterization technique.
• Analytical Instrumentation Qualification.
• Strong oral and written communication skills.
• Ability to work in a team environment with cross-functional interactions is essential.
• GMP working experience.
• Experience on analytical method qualification and transfers.

Embedded within the quality and manufacturing support function, the Analytical Associate analyzes raw materials, in-process samples, and drug product release and stability samples under cGMP conditions, performing tests such as HPLC and dissolution to ensure each product meets predetermined specifications. Working closely with manufacturing and product release teams, the role supports technical writing and data review to keep release timelines on track.

Core Functions

• Analysis of raw materials, in-process samples, and drug product release and stability samples under cGMP conditions.
• Review of analytical data.
• Technical writing in support of analytical activities related to manufacturing and product release time lines.
• Performing various analytical tests to ensure that each product meets predetermined material specifications.
• Calibration of various analytical instruments as needed.
• Occasional method validation and transfer activities.
• Testing of raw materials, in-process and finished products.
• HPLC, Dissolution, TOC, Particle size analysis, Viscosity, UV-Vis, etc.
• Maintaining the lab and inventory.

Skills & Qualifications

• College degree in chemistry or a related scientific discipline.
• Client services approach and mindset (internal and external).
• Ability to work in a fast-paced environment.
• Highly organized and detail focused.
• Strong clerical skills including data entry and document organization.
• Strong work ethic.
• Problem solving and risk mitigation skills.
• Fluent English language skills required (both written and spoken).

Reporting to the Sr. Scientist, Analytical Development, the Analytical Associate II/III leads analytical testing and qualification of flow cytometry, cell-based, and molecular assays assessing the purity, identity, function, and safety of engineered iPSC-derived NK and macrophage cell therapies. Partnering with Process Development and MSAT teams, the role contributes to assay development for cell phenotype, potency, and residual bioprocess impurity assessment in support of allogeneic, off-the-shelf cell therapy products.

Primary Duties

• Execute analytical SOPs to support process optimization and development, product release and stability, and general product characterization.
• Perform, troubleshoot, and optimize assays to support Process Development and MSAT experimentation and design of experiment projects.
• Maintain detailed experimental records, analyze and interpret data, author SOPs, and write reports.
• Perform all functions to support analytical testing and qualification in accordance with good documentation practices.
• Culture, maintain and generate well-documented banks of cell lines and primary cells required for assay development and execution.
• Order and maintain stocks of lab reagents and samples.

Knowledge Skills & Abilities

• S. or M.S. degree with a minimum of 2 years relevant lab experience in flow cytometry, cell-based, and/or molecular assays.
• Flow cytometry experience, as well as experience analyzing flow cytometry data with FlowJo software is preferred.
• Experience performing a range of analytical assays (qPCR, ddPCR, ELISA, MSD, automated cell counters) is a plus.
• Working knowledge of statistical and analytical tools.
• Experience with cell culture, aseptic technique, as well as execution of bioassays, is strongly preferred.
• Excellent communication, time management, record keeping, presentation, and data analysis skills are required.
• Experience in a GxP environment is preferred.
• Familiarity with ICH and USP guidelines for analytical method development is desirable.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Sitting at the intersection of analytical testing and project management, the Industrial Lead Analytical Associate provides expertise to projects such as new regulation implementation and stability study coordination supporting process changes within the biopharmaceutical analytical testing field. Operating across departmental and cross-product activities, the role connects with QC laboratories and operations to implement analytical lifecycle plans and integrated analytical solutions.

Operational Focus

• Providing support and expertise to specific projects led by your team or stakeholders (e.g. implementation of a new regulations, coordination of stability studies to support a process change, …).
• Implementing analytical lifecycle plans or integrated analytical solutions through Project Management.
• Being responsible for one or more cross-products activities or business processes (in full or a part of it) within the remit of your department.
• Supporting ILA's for operational activities within the remit of the department.
• Connecting with people to develop and maintain interfaces with operations (e.g. QC laboratories).

Position Requirements

• Master's Degree in Analytical Chemistry.
• At least 2 to 3 years of industrial experience in the analytical testing field of biopharmaceutical products.
• Exposure to GMP, Regulatory Affairs and Quality applied to analytical.
• Fluent in English (both written and spoken), French is a plus.
• Proven Project Management skills including planning, monitoring, issue resolution, risk mitigation and reporting.
• Show-off your energy and dynamism to evolve in a complex matrix environment.
• Work in autonomy with a problem solving and pragmatic mindset.
• Customer and results oriented.