Senior Scientist, QC Analytical

Catalent•Harmans, MD

6d•$50 - $58•Onsite

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 campus. 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 in Harmans, Maryland, on a Monday–Friday, 8 a.m.–5 p.m. shift, with occasional overtime and flexibility to support off-hours and weekend production campaigns when required. The position performs and supports analytical and molecular biology assays, including ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis, and DNA/RNA extraction. It contributes to batch release, stability, and special testing programs; serves as a technical subject matter expert; mentors laboratory staff; and supports continuous improvement. The Senior Scientist also creates and maintains GMP-controlled documentation, reviews laboratory work and data packages, supports quality investigations and change controls, and monitors laboratory equipment performance.

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 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 and 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 key analytical techniques and provide 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 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.
Monitor laboratory equipment performance, including maintenance, troubleshooting, alarm response, and coordination of corrective actions.
Communicate quality-impacting issues to management and support production campaigns outside regular hours, including weekends, when required.
Perform other duties as assigned.