QC Analytical Scientist - GMP Lab (ELISA/qPCR) Onsite

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 53,000 - 66,000; Full time

Benefits offered by this job

Defined career path

Diverse, inclusive culture

Career growth opportunities

Paid time off + 8 holidays

Benefits from day one

Job summary

Catalent is seeking a Scientist, QC Analytical in Harmans, MD to join our GMP manufacturing support team. The role focuses on analytical testing for clinical and commercial products, requiring a strong biochemistry background and GMP acumen.

You will document work, develop SOPs, and support method verification and stability testing. Ideal candidates have a Life Sciences degree with relevant cGMP lab experience and proficiency with Excel/Word.

Qualifications

• Bachelor’s degree in Life Sciences with 2+ years in a cGMP QC lab or Master’s degree with 1+ year in a cGMP QC lab.
• Experience in biologic, pharmaceutical, or medical device QC.
• Experience writing SOPs.
• Strong biochemistry foundation; ability to review docs and support quality and operations.

Responsibilities

• Perform assays (ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, pH).
• Document testing per GMP/GDP procedures.
• Create assay protocols, summary reports, SOPs.
• Provide analytical support for method verification of platform test methods.
• Support release and stability testing of materials and products.
• Review data and approve packages as directed by supervisor.
• Maintain and troubleshoot instrumentation; ensure data accuracy.
• Write investigations, OOS, deviations, CAPAs, and perform statistical analysis and trending.

Skills

SOP writing

Biochemistry

Excel and Word

Attention to detail

GMP knowledge

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Job description

Catalent is seeking a Scientist, QC Analytical in Harmans, MD to join our GMP manufacturing support team. The role focuses on analytical testing for clinical and commercial products, requiring a strong biochemistry background and GMP acumen.

You will document work, develop SOPs, and support method verification and stability testing. Ideal candidates have a Life Sciences degree with relevant cGMP lab experience and proficiency with Excel/Word.