Scientist, QC Analytical
Catalent Pharma Solutions
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.
Job description
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.
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
- Strong familiarity with GMP practices
- Experience in writing standard operating procedures (SOPs)
- Strong foundation in biochemistry
- Hands-on experience reviewing documentation and applying scientific and regulatory principles
- Excellent attention to detail and organizational skills
- Ability to work effectively in fast-paced, team-oriented environments
- Proficient in Microsoft Excel and Word
- Ability to work a set shift with occasional overtime as required
Benefits
- Medical, Dental & Vision
- Paid Time Off
- 8 Paid Holidays
- Tuition Reimbursement
- Performance Bonus
- Career Growth Path
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.