Scientist, QC Analytical Position SummaryWe 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 CandidateMinimum 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.
PayThe 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 on factors such as experience, skillset, education, and business needs. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent- Defined career path and annual performance review and feedback process.
- Diverse, inclusive culture.
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
- Competitive paid time off plus 8 paid holidays.
- Community engagement and green initiatives.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition reimbursement.
