Senior QC Analytical Scientist – Gene Therapy (Onsite)

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 144,648,000 - 165,312,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off and holidays

Job summary

Catalent's FDA-licensed Harmans facility in MD is hiring a Senior Scientist, QC Analytical. You will perform analytical testing to ensure GMP manufacturing for clinical and commercial clients, applying regulatory knowledge and scientific rigor in a fast-paced environment.

This onsite role (Mon–Fri, 8am–5pm) covers ELISA, qPCR, ddPCR, HPLC, and related QC testing; you will mentor staff, support change controls, CAPAs, and contribute to continuous improvement while ensuring quality across

Qualifications

• Bachelor’s degree in Life Sciences with 4–6 years in a cGMP QC lab, or Master’s with 2+ years in a cGMP QC lab.
• Experience with QC analytical methods for protein chemistry and molecular biology.
• GMP environments with hands-on QC work; SOP writing and data/documentation.
• Proficient in Excel and Word; strong attention to detail.

Responsibilities

• Perform a broad range of analytical and molecular biology assays (ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis).
• Troubleshoot lab issues; support batch release, stability testing, and special testing programs.
• Provide technical guidance to auditors, vendors, and cross-functional teams.
• Mentor and train laboratory staff; promote quality and compliance.
• Lead continuous improvement to lab efficiency and compliance.
• Create and maintain GMP-controlled docs (protocols, SOPs, reports).
• Review data packages and ensure accurate interpretation and reporting.
• Manage change controls, CAPAs, deviations, and OOS investigations.
• Monitor equipment performance and coordinate corrective actions.
• Communicate quality-impacting issues to management; support off-hours campaigns.
• Other duties as assigned.

Skills

QC analytical methods

ELISA

qPCR

ddPCR

HPLC

Capillary electrophoresis

DNA/RNA extraction

GMP knowledge

SOP writing

Excel

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Tools

Microsoft Excel

Microsoft Word

Job description

Catalent's FDA-licensed Harmans facility in MD is hiring a Senior Scientist, QC Analytical. You will perform analytical testing to ensure GMP manufacturing for clinical and commercial clients, applying regulatory knowledge and scientific rigor in a fast-paced environment.

This onsite role (Mon–Fri, 8am–5pm) covers ELISA, qPCR, ddPCR, HPLC, and related QC testing; you will mentor staff, support change controls, CAPAs, and contribute to continuous improvement while ensuring quality across