Senior Scientist, QC Analytical

Catalent Pharma Solutions; Harmans (MD); On-site; USD 70,000 - 79,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Tuition reimbursement

Paid time off

Holidays

Job summary

Catalent Pharma Solutions is seeking a Senior Scientist, QC Analytical, onsite at the Harmans, MD facility. You will perform diverse analytical assays, troubleshoot QA testing, and support GMP manufacturing for clinical and commercial programs. This role reports to the Sr.

Manager, Quality and involves mentoring staff, driving continuous improvement, and ensuring strict data integrity. The position requires a life sciences degree with cGMP QC lab experience; strong knowledge of

Qualifications

• Bachelor’s degree in a Life Sciences discipline with 4–6 years of experience in a cGMP QC laboratory, or Master’s degree with at least 2 years in a cGMP QC lab
• Knowledge of QC analytical methods for protein chemistry and molecular biology
• Experience in biologic/pharma industry performing hands-on QC work with GMP
• Experience in writing Standard Operating Procedures (SOPs)
• Proficient in Microsoft Excel and Word
• Strong attention to detail and ability to work in a team
• Ability to support shift work and overtime as needed

Responsibilities

• Perform and support analytical assays (ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis)
• Troubleshoot lab testing and instrumentation; support batch release and special testing
• Serve as SME for analytical techniques; provide guidance to auditors and cross-functional teams
• Mentor and develop laboratory staff to promote quality
• Lead continuous improvement to enhance efficiency, compliance, and performance
• Create, revise, and maintain GMP-controlled documents
• Review data packages and ensure accurate interpretation and reporting
• Manage change controls, CAPAs, deviations, and OOS investigations
• Monitor equipment performance and coordinate corrective actions
• Communicate quality issues to management and support off-hours/ weekend campaigns

Skills

QC analytical methods

GMP / cGMP

SOP writing

Excel / Word

Analytical chemistry

Problem solving

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Tools

ELISA

qPCR

ddPCR

HPLC

Capillary electrophoresis

DNA/RNA extraction

Job description

Senior 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 Senior Scientist, QC Analytical to join our team. In this role, you will support analytical testing to ensure GMP manufacturing for clinical and commercial clients. You will apply your technical knowledge, regulatory understanding, and commitment to scientific excellence to deliver high-quality results. This position reports to the Sr. Manager, Quality and offers the chance to work in a dynamic, fast-paced environment.

Shift: Monday – Friday, 8am-5pm
Location: Harmans, MD - BWI
100% Onsite

The Role

• Perform and support a broad range of analytical and molecular biology assays, including ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis, DNA/RNA extraction, and related quality control testing.
• Troubleshoot laboratory, testing, and instrumentation issues, elevate concerns as needed, and recommend solutions to support batch release, stability, and special testing programs.
• Serve as a subject matter expert for key analytical techniques, providing technical guidance to auditors, vendors, and cross-functional teams.
• Mentor, train, and develop laboratory staff while promoting technical excellence and adherence to quality standards.
• Lead and support continuous improvement initiatives to enhance laboratory efficiency, compliance, and operational performance.
• Create, revise, and maintain technical documentation, including assay protocols, SOPs, summary reports, and other GMP-controlled records.
• Review laboratory work, approve data packages, and ensure accurate data interpretation and reporting in accordance with quality requirements.
• Manage and support change controls (CRs), CAPAs, deviations, OOS investigations, and issue resolution activities to ensure product quality and compliance.
• Monitor laboratory equipment performance, including maintenance, troubleshooting, alarm response, and coordination of corrective actions.
• Communicate quality-impacting issues to management and maintain flexibility to support unique production campaigns, including off-hours and weekend operations when required.
• Other duties as assigned

The Candidate

Minimum Requirements

• Bachelor’s degree in a Life Sciences discipline with 4–6 years of experience in a cGMP QC laboratory, or Master’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory
• Knowledge and expertise in QC analytical methods used for protein chemistry and molecular biology
• Experience in the biologic, pharmaceutical, or medical device industry performing hands‑on QC work with strong familiarity of GMP practices
• Experience in writing Standard Operating Procedures (SOPs)
• Broad experience with biochemistry and related documentation
• Proficient in applying basic scientific and regulatory principles to solve operational and quality tasks
• Experience with Microsoft Excel and Microsoft Word
• Strong attention to detail and organizational skills
• Ability to succeed in a team‑oriented environment under dynamic conditions
• 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 $50.48 – $57.69 Plus Bonus. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. 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

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.