Senior Scientist, QC Analytical
About The Position
The Senior Scientist, QC Analytical supports analytical testing to ensure GMP manufacturing for clinical and commercial clients at Catalent’s Harmans/BWI site. The role applies technical knowledge, regulatory understanding, and scientific rigor to deliver high-quality results in a dynamic, fast-paced environment. It reports to the Sr. Manager, Quality and is 100% onsite, Monday through Friday, 8 a.m. to 5 p.m., with occasional overtime and off-hours or weekend support when required. The position performs and supports analytical and molecular biology assays, troubleshoots laboratory and instrumentation issues, and provides technical guidance as a subject matter expert. It also mentors laboratory staff, leads continuous improvement, maintains GMP documentation, reviews and approves data packages, supports quality investigations and change controls, and monitors laboratory equipment. The role supports production campaigns and other duties as assigned.
Requirements
- Bachelor’s degree in a Life Sciences discipline and 4–6 years of experience in a cGMP QC laboratory, or a Master’s degree in a Life Sciences discipline and 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.
- Hands-on QC experience in the biologic, pharmaceutical, or medical device industry, with strong familiarity with GMP practices.
- Experience writing Standard Operating Procedures (SOPs).
- Broad experience with biochemistry and related documentation.
- Proficiency 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 ELISA, qPCR, ddPCR, HPLC, and capillary electrophoresis.
Responsibilities
- Perform and support analytical and molecular biology assays, including ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis, DNA/RNA extraction, and related QC testing.
- Troubleshoot laboratory, testing, and instrumentation issues; escalate concerns and recommend solutions for batch release, stability, and special testing programs.
- Serve as a subject matter expert for 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 improve laboratory efficiency, compliance, and operational performance.
- Create, revise, and maintain 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, CAPAs, deviations, OOS investigations, and issue resolution activities.
- Monitor laboratory equipment performance, including maintenance, troubleshooting, alarm response, and coordination of corrective actions.
- Communicate quality-impacting issues to management and support production campaigns, including off-hours and weekend operations when required.
- Perform other duties as assigned.
Benefits
- Competitive paid time off and 8 paid holidays.
- Medical, dental, and vision benefits effective on the first day of employment.
- Tuition reimbursement.
- Potential for career growth and a defined career path.
- Annual performance review and feedback process.
- Diverse, inclusive culture.
- Community engagement and green initiatives.
- Bonus; amount or structure not specified.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
