Quality Control Chemistry Analyst II

Quality Control Chemistry Analyst II

Supporting the production of AAV Viral Vector Gene Therapy Drug Products, the analyst performs analytical and bioanalytical testing on starting materials, in‑process and finished drug products, stability samples, and engages in process characterization and development projects.

• Perform analytical and bioanalytical testing of starting materials, in‑process and finished drug products, and stability samples using analytical test methods, product and residual content assays, and compendial methods.
• Conduct product characterization assays to support product development and PPQ campaigns.
• Support method qualification, validation, and transfer to QC laboratories.
• Monitor lab equipment for instrumentation issues or calibration needs.
• Contribute to document revisions related to SOPs and Work Instructions.
• Troubleshoot and resolve method and instrument issues successfully.
• Independently contribute to Laboratory Investigations, OOS/OOT results, Deviations, CAPA, and Change Control record closure.
• Participate in cross‑functional teams for Operation Excellence, Root Cause analysis, and risk assessments.
• Provide training to department teammates on assays qualified to perform.
• Maintain Analytical laboratories in compliance and inspection readiness.
• Cross‑train in Quality Control sample receipt and Contract Testing Lab management functions.
• Maintain inventory of critical assay reagents and consumables.
• Adapt to unique manufacturing campaign testing requirements, including off‑hour and weekend work.

• Proficiency in quality control, analytical chemistry, and bioanalytical techniques.
• Experience with HPLC, CGE, Osmolality, CE, size exclusion chromatography, and GDP.
• Understanding of Good Manufacturing Practices (cGMP).
• Strong scientific knowledge and hands‑on lab experience with analytical methods, microscopy, and aseptic techniques.
• Excellent attention to detail and organizational skills.
• Proficient written and verbal communication skills in a team‑oriented environment.

• B.S. or A.S. in a Life Sciences discipline preferred.
• 2–4 years of relevant experience in a cGMP environment.
• Experience in cGMP Quality Control, preferably in a Biologics or CGT setting.
• Ability to independently perform experiments for assay development, product release, stability, and characterization.
• Knowledge and ability to apply basic scientific and regulatory principles.

This position requires adherence to federal and local regulations, laboratory health and safety procedures, and company SOPs. Lab work is conducted in a biosafety level 2 laboratory with exposure to chemicals, necessitating personal protective equipment. Employees must be able to lift and move up to 30 lbs and may need to stand for up to 4 hours in an 8‑hour workday.

Work is conducted in a shared laboratory environment.

Contract position based out of ROCKVILLE, MD. Final date to receive applications: anticipated to close on Jan 23 2026.

Pay range: $38.00 – $40.00 /hr. Eligible benefits for this temporary role may include:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom for other accommodation options.