Scientist (Instrument Qualification)

Title: Metrologist

Location: Exton, PA

Reports to: Chemistry, Manufacturing, and Controls (CMC) Analytical Services Manager

Full-time (40 hrs./week)

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

Frontage Laboratories, Inc. is hiring an Associate/Mid-Level/Senior Metrologist in CMC Services. The Metrologist provides cGMP analytical laboratory equipment calibration and qualification support, including drafting and execution qualification/validation protocols, instrument calibration, maintenance, and decommissioning.

Roles & Responsibilities:

• Support the BCGT/CMC Labs at Frontage Laboratories, Inc in Exton, PA.
• Calibrate and qualify laboratory instruments to ensure minimal downtime (e.g., HPLC, UPLC, GC, ICP-OES, UV-Vis, FTIR, Stability Chambers, etc.).
• Monitor and schedule the preventative maintenance and calibration of laboratory instrumentation.
• Install and configure new laboratory equipment.
• Monitor equipment failures to determine the need for appropriate remediation.
• Maintain analytical instrument records in accordance with GMP documentation requirements.
• Draft equipment change controls and instrument related deviations.
• Review GMP data related to the qualification of analytical instruments and laboratory equipment.
• Coordinate/interface/host vendors on site.
• Comply with all relevant cGMP regulatory requirements and internal SOPs while conducting assigned tasks.
• Other duties as assigned.

Education, Experience & Skills Required:

• Bachelor’s degree in relevant scientific, engineering, or computer-based area.
• Experience in a regulated pharmaceutical or related industry will determine level.
• Working knowledge of Microsoft Office Applications.
• Excellent organization and communication skills.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.