Senior QC Analytical Scientist - Onsite Mon-Fri

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

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.