Senior Scientist, QC Analytical
About The Position
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.
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
Nice To Haves
- Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis
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
Benefits
- Competitive paid time off plus 8 paid holidays
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Senior
