QC Analytical Scientist - GMP Testing

Catalent Pharma Solutions; Maryland; On-site; USD 53,000 - 66,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off and holidays

Onsite well-equipped facilities

Job summary

Catalent Pharma Solutions in Harmans, MD is seeking a Scientist, QC Analytical to support analytical testing for GMP manufacturing of clinical and commercial products. The role requires strong technical knowledge, familiarity with regulatory principles, and a commitment to scientific excellence.

100% onsite shift is Monday–Friday, 8am–5pm. The candidate will perform assays (ELISA, qPCR, HPLC, Capillary Electrophoresis) and document results per GMP/GDP.

Qualifications

• Bachelor’s degree in Life Sciences with 2+ years in a cGMP QC lab.
• Master’s degree in Life Sciences with 1+ year in a cGMP QC lab.
• Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work.
• Experience in writing standard operating procedures (SOPs).
• Strong biochemistry foundation; attention to detail and teamwork.

Responsibilities

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH.
• Document testing in compliance with GMP/GDP procedures.
• Generate internal and external documents such as assay protocols, summary reports, and SOPs.
• Provide analytical support to QC method services for method verification of platform test methods.
• Support release and stability testing for raw materials, components, standards, and finished products.
• Review laboratory work and approve data packages as designated by the Supervisor.
• Maintain and troubleshoot instrumentation, ensuring accurate data interpretation.
• Write laboratory investigations, out-of-specification reports, deviations, CAPAs, and perform statistics.
• Review paper and electronic records for accuracy and compliance.
• Report issues to management and participate in investigations.
• Work under general supervision to meet project goals and occasional overtime.
• Participate in training activities and manage training plans.

Skills

ELISA

qPCR

ddPCR

HPLC

Capillary Electrophoresis

GMP

Documentation

SOP writing

Excel

Word

Education

Bachelor’s degree in Life Sciences with 2+ years in a cGMP QC lab

Master’s degree in Life Sciences with 1+ year in a cGMP QC lab

Job description

Catalent Pharma Solutions in Harmans, MD is seeking a Scientist, QC Analytical to support analytical testing for GMP manufacturing of clinical and commercial products. The role requires strong technical knowledge, familiarity with regulatory principles, and a commitment to scientific excellence.

100% onsite shift is Monday–Friday, 8am–5pm. The candidate will perform assays (ELISA, qPCR, HPLC, Capillary Electrophoresis) and document results per GMP/GDP.