Scientist, QC Analytical

Catalent•Harmans, MD

7d•$38 - $48•Onsite

About The Position

The Scientist, QC Analytical supports analytical testing for GMP manufacturing of clinical and commercial products at Catalent’s Harmans/BWI gene therapy manufacturing campus. The role requires strong technical knowledge, familiarity with scientific and regulatory principles, and a commitment to scientific excellence. The position reports to the Supervisor, QC Analytical and contributes to maintaining high standards in testing and documentation. The role is based 100% onsite in Harmans, Maryland, and is scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m. Work may occasionally take place outside those hours or on weekends as needed.

Requirements

Bachelor’s degree in a Life Sciences discipline and at least 2 years of experience in a cGMP QC laboratory, or a Master’s degree in a Life Sciences discipline and at least 1 year of experience in a cGMP QC laboratory.
Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work, with strong familiarity with GMP practices.
Experience writing standard operating procedures (SOPs).
Strong foundation in biochemistry, with hands-on experience reviewing documentation and applying scientific and regulatory principles to support quality and operational activities.
Excellent attention to detail and organizational skills, and ability to work effectively in fast-paced, team-oriented environments.
Proficiency in Microsoft Excel and Word for managing documentation, analyzing data, and supporting business processes.
Ability to work a set shift with occasional overtime as required.

Nice To Haves

Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.

Responsibilities

Perform assays including ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, appearance, osmolality, and pH.
Document testing in compliance with GMP/GDP procedures.
Generate internal and external documents, including assay protocols, summary reports, and standard operating procedures (SOPs).
Provide analytical support to QC method services for 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 and ensure accurate data interpretation.
Write laboratory investigations, out-of-specification reports, deviations, and corrective and preventive actions (CAPAs); perform statistical analysis and trending.
Review paper and electronic records for accuracy and compliance.
Report issues to management and participate in issue resolution and investigations.
Work under general supervision to meet project goals and adapt to off-hour or weekend work as needed.
Participate in training activities and manage individual training plans.
Perform other duties as assigned.