Scientist, QC Analytical

Scientist, QC Analytical

About Site

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities, is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Position Summary

We have an opportunity for a Scientist, QC Analytical to join our team supporting analytical testing for GMP manufacturing of clinical and commercial products. This role requires strong technical knowledge, familiarity with scientific and regulatory principles, and a commitment to scientific excellence. The Scientist, QC Analytical will report to the Supervisor, QC Analytical and contribute to maintaining high-quality standards in testing and documentation.

Shift: Monday – Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite

The Role

- Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH.
- Document testing in compliance with GMP/GDP procedures.
- Generate internal and external documents such as assay protocols, summary reports, and standard operating procedures (SOPs).
- Provide analytical support to QC method services for method verification of platform test methods.
- Support release and stability testing for raw materials, components, standards, and finished products.
- Review laboratory work and approve data packages as designated by the Supervisor.
- Maintain and troubleshoot instrumentation, ensuring accurate data interpretation.
- Write laboratory investigations, out-of-specification reports, deviations, corrective and preventive actions (CAPAs), and perform statistical analysis and trending.
- Review paper and electronic records for accuracy and compliance.
- Report issues to management and participate in issue resolution and investigations.
- Work under general supervision to meet project goals and adapt to off-hour or weekend work as needed.
- Participate actively in training activities and manage individual training plans.
- Perform other duties as assigned.

The Candidate

Minimum Requirements

- Bachelor’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory, or a Master’s degree in a Life Sciences discipline with at least 1 year of experience in a cGMP QC laboratory.
- Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work with strong familiarity with GMP practices.
- Experience in writing standard operating procedures (SOPs).
- Strong foundation in biochemistry with hands-on experience reviewing documentation and applying scientific and regulatory principles to support quality and operational activities.
- Demonstrates excellent attention to detail, organizational skills, and the ability to work effectively in fast-paced, team-oriented environments.
- Proficient in Microsoft Excel and Word, leveraging these tools to manage documentation, analyze data, and support business processes.
- Ability to work a set shift with occasional overtime as required.

Preferred Skills & Background

- Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.

Pay

The anticipated hourly rate for this position in MD is $38.46 – $48.07 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend on factors such as experience, skillset, education, and business needs. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive paid time off plus 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition reimbursement.

Catalent offers rewarding opportunities to further your career!   Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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