Principal Scientist-Quality Control, Instrumentation
About The Position
The Principal Scientist-Quality Control, Instrumentation role at Catalent involves monitoring and coordinating instrument installation and maintenance, operating various cGMP Quality Control equipment, and managing the full lifecycle of laboratory equipment and vendor relationships. Catalent is a leading global contract development and manufacturing organization (CDMO) dedicated to developing, manufacturing, and supplying products that help people live better and healthier lives. This position requires interaction as a Subject Matter Expert (SME) for internal and external entities, leading training on analytical instruments and processes, and performing self-review of analytical data for accuracy and consistency with SOPs. The role also includes general lab housekeeping, routine and preventive maintenance on complex equipment, participation in team meetings, and writing technical documents. All tasks must adhere to Lean Six Sigma Clean room procedures, aseptic technique, cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) following standard operating procedures (SOP).
Requirements
- Bachelor’s degree in Pharmaceutical Sciences or Related Field.
- 8 years of experience in job offered or 8 years of experience in the Related Occupation (Chemist or any other job title performing all listed job duties).
- Experience with Lean Six Sigma Clean room procedure.
- Experience with aseptic technique.
- General lab equipment experience.
- Knowledge of cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP).
- Ability to follow standard operating procedures (SOP).
- Proficiency with laboratory equipment including Agilent, Waters, and Thermo HPLC/UHPLCs (with VWD, MWD, DAD, CAD, ELSD), LC/MS, GC, Sciex PA800 Plus (including LIF detector), Protein Simple iCE3 and Maurice, Biotech and Molecular Devices Plate Washers and Plate Readers, Applied BioSystems 3500xL, Applied BioSystems 7500 Fast, Controlled Temperature Units (multiple vendors), pH Meters (multiple vendors), Balances (multiple vendors), and Pipettes (multiple types and multiple vendors).
Responsibilities
- Monitor and coordinate instrument installation and maintenance.
- Operate basic, moderately complex, and complex cGMP Quality Control equipment.
- Manage all aspects of laboratory equipment lifecycle.
- Manage all aspects of equipment vendor management.
- Prioritize and schedule activities to meet deadlines.
- Interact as an SME for internal and external entities.
- Lead training of specific analytical instruments and processes.
- Perform self-review of analytical data for accuracy and consistency with SOP.
- Perform general lab housekeeping in adherence to 5S standards.
- Complete routine and preventive maintenance on basic, moderately complex, and complex equipment.
- Participate in team meetings and/or training sessions.
- Write technical documents.
- Maintain and troubleshoot Quality Control equipment.
- Perform duties using Lean Six Sigma Clean room procedure, aseptic technique, and general lab equipment experience.
- Perform duties following cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) following standard operating procedures (SOP).
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Number of Employees
5,001-10,000 employees
