Associate Scientist, Quality Control

Job Description

Job Description

Job Title: Associate Scientist, Quality Control – Analytical Development

Job Description

The Associate Scientist, Quality Control will support the Analytical Development team in developing, optimizing, implementing, and supporting robust analytical methods that enable a deep understanding of cell therapy products and processes. In this role, you will execute analytical operations that contribute to the development and qualification of critical assays, provide analytical support for process development and cGMP manufacturing activities, and help ensure CMC readiness for early and late phase clinical assets. You will work extensively at the bench with bioanalytical and cell-based assays, collaborate with cross-functional teams, and apply your experience in cell therapy, CAR-T, and bioanalytical techniques in a fast-paced, highly regulated environment.

Responsibilities

• Support all aspects of assay lifecycle management for bioanalytical and cell-based assays, including development, optimization, qualification, and transfer.
• Independently design and execute experimental protocols in support of analytical development activities.
• Provide analytical support for cell therapy manufacturing process development and characterization activities.
• Perform routine characterization testing on in-process, final product, and stability samples according to established SOPs in support of clinical trials.
• Perform cell culturing and maintenance of human and non-human mammalian cell lines.
• Maintain aseptic technique while working within a biosafety cabinet in a BSL-2 environment.
• Properly record and report all generated data in accordance with current Good Documentation Practices.
• Review data recorded by peers for accuracy, completeness, and adherence to current Good Documentation Practices.
• Effectively communicate experimental data, interpretations, and conclusions to peers, department leadership, and cross-functional teams within Technical Operations.
• Perform daily, weekly, and monthly maintenance on laboratory equipment and analytical instruments.
• Prepare, operate, and maintain delicate analytical instruments used in bioanalytical and cell-based assays.
• Prepare, analyze, and properly discard biological samples and materials in compliance with safety and environmental requirements.
• Maintain a clean, organized, and safe working environment in the laboratory.
• Maintain an understanding of applicable regulatory guidelines for assay development, implementation, qualification, and CMC readiness.
• Adhere strictly to company policies, rules, regulations, and safety procedures while handling hazardous chemicals and substances.
• Contribute to cross-functional project teams by representing the interests and needs of the Analytical Development group.
• Manage priorities and timelines effectively to meet key departmental deliverables and project milestones.

Essential Skills

• Bachelor’s degree and 4+ years of experience, or Master’s degree and 2+ years of experience in cell and molecular biology, immunology, biochemistry, or another relevant life science field.
• At least 2+ years of biotech industry experience, with a preference for experience in cell therapeutics.
• Hands-on experience with flow cytometry (FACS) for cell therapy or related applications.
• Proficiency with ELISA and other immunoassay-based bioanalytical techniques.
• Experience with cell-based potency assays such as IFN-γ release assays and direct cell killing measurements.
• Experience with metabolic function assays, including platforms such as Seahorse, MTT assay, and MetaFLEX.
• Experience performing qPCR for analytical or characterization purposes.
• Experience with image-based cell counting methods and instruments.
• Demonstrated ability to culture and maintain human and non-human mammalian cell lines.
• Strong aseptic technique and experience working within a biosafety cabinet in a BSL-2 laboratory.
• Experience with assay development and optimization for cell therapy or related applications.
• Familiarity with release testing and quality control activities for biologics or cell therapy products.
• Strong technical writing skills for documenting methods, results, and reports.
• Effective data presentation skills, including the ability to summarize and interpret complex data sets.
• Strong verbal communication skills for collaboration with peers, management, and cross-functional teams.
• Demonstrated critical thinking and problem-solving skills in a laboratory setting.
• Strong time management skills and the ability to manage multiple tasks and timelines in parallel.
• Understanding of current Good Documentation Practices and their application in a regulated environment.

Additional Skills & Qualifications

• Experience in cell therapy and CAR-T technologies, including cell therapy assay development.
• Experience in bioanalytical techniques relevant to cell therapy products and CMC readiness.
• Experience supporting cGMP manufacturing activities through analytical testing and method support.
• Familiarity with analytical method qualification and transfer processes.
• Ability to represent Analytical Development needs on cross-functional teams and contribute to CMC strategy.
• Interest in working at the interface of process development, quality control, and clinical development.
• Ability to quickly learn and follow established QC procedures and company protocols, with openness to additional training.
• Strong attention to detail and commitment to data integrity and regulatory compliance.

Work Environment

This role is primarily laboratory-based, with approximately 60% of the time spent at the bench in a BSL-2 environment and the remainder at a desk for data analysis, documentation, and communication. You will perform assays, generate and analyze data, and work with delicate analytical instruments that require careful preparation, operation, and routine maintenance. The position involves handling and culturing human and non-human mammalian cells, as well as preparing, analyzing, and properly discarding biological samples and materials. You may handle hazardous chemicals and substances, and you will work in an environment where safety, environmental, and health considerations demand constant attention. Strict adherence to company policies, rules, regulations, and safety procedures is required. Appropriate personal protective equipment, including eye protection, gloves, shoes, and a lab coat, must be worn as required. The role may involve extended periods of standing while performing laboratory work, along with periods of computer-based work for data analysis, documentation, and reporting. The environment supports collaboration with cross-functional teams and offers exposure to CMC readiness activities, QC training, and advanced cell therapy technologies such as CAR-T.

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

The pay range for this position is $30.00 - $36.00/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 Frederick,MD.

This position is anticipated to close on Jul 13, 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.