Quality Control Chemistry Senior Analyst

Job Description

Job Description

Job Title: Quality Control Chemistry Senior Analyst

Job Description

The Quality Control Chemistry Senior Analyst supports the manufacture of AAV viral vector drug products by performing complex analytical and bioanalytical testing across the product lifecycle. This role focuses on testing starting materials, in-process and finished drug products, and stability samples, while also contributing to process characterization and development projects. The position offers the opportunity to build or deepen experience in cell and gene therapy within a positive, fast-paced environment focused on treatments for pediatric rare diseases.

Responsibilities

• Perform analytical and bioanalytical testing of starting materials, in-process and finished drug products, and stability samples using validated analytical methods, product and residual content assays, and applicable compendial methods.
• Execute product characterization assays to support product development activities and process performance qualification (PPQ) campaigns.
• Support method qualification, validation, and transfer into Quality Control laboratories, ensuring methods are robust, compliant, and suitable for routine use.
• Monitor laboratory equipment to identify instrumentation issues or calibration needs and coordinate timely resolution or maintenance.
• Author and revise documentation, including Standard Operating Procedures (SOPs) and Work Instructions, to ensure clarity, accuracy, and regulatory compliance.
• Troubleshoot and resolve analytical methods and instrument issues, driving them to successful resolution with appropriate documentation.
• Independently contribute to laboratory investigations, including out-of-specification (OOS) and out-of-trend (OOT) results, deviations, corrective and preventive actions (CAPA), and change control records.
• Participate in cross-functional teams focused on operational excellence, root cause analysis, and risk assessments to improve processes and systems.
• Provide training and mentorship to teammates on assays and methods for which you are qualified, promoting consistency and technical excellence across the team.
• Maintain analytical laboratories in a constant state of inspection readiness and compliance with cGMP and internal quality standards.
• Cross-train to perform Quality Control sample receipt activities and manage testing performed by contract testing laboratories.
• Maintain inventory of critical assay reagents, reference standards, and consumables to ensure uninterrupted laboratory operations.
• Perform sample management activities as part of the analytical team, including labeling, storage, tracking, and chain-of-custody documentation.
• Independently perform experiments to support assay development, product release, stability testing, and product characterization with minimal supervision.
• Apply Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in all laboratory activities and records.
• Adhere to all applicable regulations, laboratory health and safety procedures, and internal SOPs, policies, and guidelines.
• Work flexibly to support unique manufacturing campaign testing requirements, including off-hour and weekend work on a three-week rotation, and adjust start times as needed to support late testing.

Essential Skills

• Bachelor’s degree (B.S.) preferred or Associate’s degree (A.S.) in a Life Sciences discipline.
• At least 6–8 years of relevant experience working in a cGMP environment, with a preference for approximately 8 years of experience.
• Demonstrated experience working in cGMP Quality Control, preferably within biologics or cell and gene therapy (CGT) settings.
• Strong hands-on laboratory experience with analytical chemistry methods and bioanalytical techniques.
• Proficiency with High-Performance Liquid Chromatography (HPLC), with substantial practical experience.
• Experience with Capillary Gel Electrophoresis (CGE) and Capillary Electrophoresis (CE).
• Experience with size exclusion chromatography and related analytical techniques.
• Familiarity with compendial testing and compendial methods.
• Experience with biologics and cell therapy analytical testing.
• Demonstrated use of aseptic technique in laboratory settings.
• Experience with product release, stability testing, and product characterization assays.
• Experience in assay development and execution of analytical methods.
• Knowledge and application of Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDP).
• Ability to independently perform experiments and analytical testing with minimal supervision.
• Strong attention to detail and excellent organizational skills to manage multiple testing activities and documentation.
• Proficient written and verbal communication skills in a team-oriented environment.
• Ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.
• Quality Control background is required, particularly with emphasis on HPLC and CGE.
• Flexibility to work off-hours and weekends on a rotational basis to support manufacturing campaigns.

Additional Skills & Qualifications

• Experience in a Quality Control role within biologics or cell and gene therapy environments is highly desirable.
• Hands-on experience with microscopy in a laboratory setting.
• Experience supporting method qualification, validation, and method transfer activities.
• Experience authoring and managing quality records, including deviations, investigations, CAPA, and change control.
• Experience participating in operational excellence initiatives, root cause analysis, and risk assessments.
• Prior involvement in managing contract testing laboratories and coordinating external testing.
• Demonstrated ability to train and mentor colleagues on analytical assays and laboratory procedures.
• Comfort working in a fast-paced environment with changing priorities and evolving project needs.
• Motivation to contribute to therapies for pediatric rare diseases and to work in a mission-driven culture focused on real-world patient impact.
• Strong collaboration skills and ability to work effectively in cross-functional teams.

Work Environment

This role is based in a laboratory environment operating under cGMP conditions and strict quality and safety standards. Employees must adhere to all applicable federal and local regulations, laboratory health and safety procedures, and company Standard Operating Procedures, policies, and guidelines. Work is performed in a biosafety level 2 (BSL-2) laboratory with some exposure to chemicals and biological materials. Appropriate personal protective equipment (PPE) is required at all times in the lab, and employees work in a shared laboratory space alongside other team members. The position involves physical activities such as lifting and moving up to 30 pounds with or without reasonable accommodations and standing for up to 4 hours during an 8-hour workday. The environment is positive, collaborative, and fast-paced, with a strong focus on operational excellence and continuous improvement. Work hours may include off-hour and weekend shifts on a three-week rotation to support unique manufacturing campaigns, with flexibility to adjust start and end times as needed. The organization emphasizes a supportive culture, opportunities to gain or expand industry experience in cell and gene therapy, and the chance to contribute to meaningful work on therapies for pediatric rare diseases.

This is a Contract position based out of ROCKVILLE, MD.

The pay range for this position is $50.00 - $54.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• 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)

This is a fully onsite position in ROCKVILLE,MD.

This position is anticipated to close on Jun 26, 2026.

About Actalent

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.