Senior Scientist, QC Analytical
Catalent
Summary
Support analytical testing to ensure GMP manufacturing for clinical and commercial clients. Apply technical knowledge, regulatory understanding, and commitment to scientific excellence to deliver high-quality results. Reports to the Sr. Manager, Quality.
Job description
Position Summary
Support analytical testing to ensure GMP manufacturing for clinical and commercial clients. Apply technical knowledge, regulatory understanding, and commitment to scientific excellence to deliver high-quality results. Reports to the Sr. Manager, Quality.
The Role
- 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.
The Candidate
Minimum 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 & Background
Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.
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
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 8 Paid Holidays
- Tuition Reimbursement
- Annual Performance Review
- Career Growth Opportunities
- Bonus
Company overview
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) that serves as a trusted partner to pharmaceutical, biotech, and consumer health companies worldwide. Founded on a legacy dating back to 1933, Catalent has evolved into a comprehensive drug development and delivery leader with over 40 global sites. The company specializes in providing end-to-end solutions spanning oral dose formulations, biologics, specialty products, and clinical supply services. Catalent's expertise includes formulation development, analytical services, commercial manufacturing, and advanced delivery technologies such as Zydis® fast-dissolve tablets and softgel technologies. With over 1,000 active development programs at any given time, the company launches more than 100 new products and line extensions annually and has supported half of all FDA approvals over the past decade. Catalent produces over 60 billion treatment doses per year, helping approximately 200 million patients annually. Headquartered in Tampa, Florida, the company employs more than 10,000 professionals globally who are dedicated to putting patients first and championing the missions that matter in healthcare innovation.