Scientist, QC Analytical
About Site
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities, is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.
The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.
The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.
Position Summary
We have an opportunity for a Scientist, QC Analytical to join our team supporting analytical testing for GMP manufacturing of clinical and commercial products. This role requires strong technical knowledge, familiarity with scientific and regulatory principles, and a commitment to scientific excellence. The Scientist, QC Analytical will report to the Supervisor, QC Analytical and contribute to maintaining high-quality standards in testing and documentation.
Shift: Monday – Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite
The Role
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 standard operating procedures (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, corrective and preventive actions (CAPAs), and 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 actively in training activities and manage individual training plans.
Perform other duties as assigned.
The Candidate
Minimum Requirements
Bachelor’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory, or a Master’s degree in a Life Sciences discipline with 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 in 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.
Demonstrates excellent attention to detail, organizational skills, and the ability to work effectively in fast-paced, team-oriented environments.
Proficient in Microsoft Excel and Word, leveraging these tools to manage documentation, analyze data, and support business processes.
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.
Pay
The anticipated hourly rate for this position in MD is $38.46 – $48.07 plus bonus. The final hourly rate offered to a successful candidate may vary and will depend…