Senior Scientist, QC Analytical

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus, featuring two manufacturing facilities. The campus is 5 miles from Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location, close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 facility is EMA and FDA approved, spanning approximately 200,000 sq. ft. with 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, under development at approximately 145,000 sq. ft., 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.

About the Role

We have an opportunity for a Senior Scientist, QC Analytical to support analytical testing ensuring GMP manufacturing for clinical and commercial clients. This role applies technical knowledge, regulatory understanding, and a commitment to scientific excellence to deliver high-quality results in a dynamic, fast-paced environment. This position reports to the Sr. Manager, Quality and is 100% onsite.

Responsibilities

• Perform and support a broad range of analytical and molecular biology assays, including ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis, DNA/RNA extraction, and related quality control testing.
• Troubleshoot laboratory, testing, and instrumentation issues, escalate concerns as needed, and recommend solutions to support batch release, stability, and special testing programs.
• Serve as a subject matter expert for key analytical techniques, providing technical guidance to auditors, vendors, and cross-functional teams.
• Mentor, train, and develop laboratory staff while promoting technical excellence and adherence to quality standards.
• Lead and support continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational performance.
• Create, revise, and maintain technical documentation, including assay protocols, SOPs, summary reports, and other GMP-controlled records.
• Review laboratory work, approve data packages, and ensure accurate data interpretation and reporting in accordance with quality requirements.
• Manage and support change controls (CRs), CAPAs, deviations, OOS investigations, and issue resolution activities to ensure product quality and compliance.
• Monitor laboratory equipment performance, including maintenance, troubleshooting, alarm response, and coordination of corrective actions.
• Communicate quality-impacting issues to management and maintain flexibility to support unique production campaigns, including off-hours and weekend operations when required.
• Other duties as assigned.

Requirements

• Bachelor’s degree in a Life Sciences discipline with 4–6 years of experience in a cGMP QC laboratory, or Master’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory.
• Knowledge and expertise in QC analytical methods used for protein chemistry and molecular biology.
• Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work with strong familiarity of GMP practices.
• Experience in writing Standard Operating Procedures (SOPs).
• Broad experience with biochemistry and related documentation.
• Proficient in applying basic scientific and regulatory principles to solve operational and quality tasks.
• Experience with Microsoft Excel and Microsoft Word.
• Strong attention to detail and organizational skills.
• Ability to succeed in a team-oriented environment under dynamic conditions.
• Ability to work a set shift with occasional overtime as required.

Preferred Skills

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

Pay

The anticipated hourly rate for this position in MD is $50.48 – $57.69 plus bonus. The final hourly rate offered to a successful candidate may vary and will be dependent on several factors, including experience, skillset, education, and business needs.

Schedule

Monday – Friday, 8am–5pm.

Benefits

• 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.