Senior Scientist, QC Analytical

Catalent; Harmans (MD); Presencial; USD 69.000 - 80.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Defined career path

Diverse, inclusive culture

Medical, dental, and vision benefits

Descripción de la vacante

Catalent is seeking a Senior Scientist, QC Analytical to join our Harmans, MD facility. You will perform and support a broad range of analytical assays to ensure GMP manufacturing for clinical and commercial clients.

The role requires expertise in ELISA, qPCR, ddPCR, HPLC and related QC testing, SOP writing, and documentation, with a focus on accuracy, compliance, and continuous improvement.

Formación

• 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 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 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 work a set shift with occasional overtime as required

Responsabilidades

• Perform and support analytical and molecular biology assays (ELISA, qPCR, ddPCR, HPLC, capillary electrophoresis)
• Troubleshoot laboratory issues and support batch release, stability, and testing programs
• Serve as a subject matter expert for analytical techniques and assist auditors and cross-functional teams
• Mentor, train, and develop laboratory staff while promoting quality standards
• Lead continuous improvement to enhance laboratory efficiency, compliance, and performance
• Create, revise, and maintain GMP documentation (SOPs, protocols, summary reports)
• Review data packages and ensure accurate interpretation and reporting

Conocimientos

QC analytical methods

SOP writing

Biochemistry docs

MS Excel

MS Word

Attention to detail

Team-oriented

Set shift

Educación

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

Herramientas

ELISA

qPCR

ddPCR

HPLC

Capillary electrophoresis

Descripción del empleo

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 and Location

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 emp