Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health , urology , gastroenterology , endocrinology and osteoarthritis .
Provide direct input to new facility and microbiological laboratory start-up activities such as, but not limited to: clean utility qualification; facility validation; production process validation; instrumentation qualification/validation; validation of test methods; generation of procedures; training of analysts.
Work with the QC Manager to set up environmental, facility and personnel monitoring programs.
Assist the QC Manager in the day to day operations of the analytical laboratory
Responsible for management of the quality control laboratory including analytical testing (HPLC, wet chemistry, etc.); review of bioassay, etc.; assure timely calibration of equipment/instruments
Supervises the activity of direct reports by scheduling assays, personnel and equipment to ensure timely completion of routine
Review/approval of analytical and bio-analytical test results using LIMS
Develops and maintains applicable laboratory procedures, documentation and records
Responsible for the training/mentoring of analysts.
Participates in lab audits and inspections. Ensure laboratory compliance
Monitor results for trends; perform laboratory investigations as required; implement CAPAs as needed.
· BS degree in Chemistry, Biology or other related scientific field
· 5+ years’ relevant experience within the biopharmaceutical industry with experience in biotechnology and bio-analytical methodologies, including HPLC, bioassays.
· 3+ years of supervisory experience or demonstrated leadership role preferred.
· Demonstrated knowledge of GMPs, FDA and other regulatory requirements is required
· Quality Systems experience desirable.
· Advanced knowledge of analytical methods and testing required.
Knowledge of LIMS preferred
· Ability to work independently and in a team environment
· Excellent leadership skills
· Excellent communication skills
· Excellent organizational skills
· Ability to communicate and motivate a diverse workforce effectively at all levels of the organization.
· Skilled in problem solving techniques including the ability to work closely with peers and other departments to identify and solve complex technical, product and production related issues
Ferring Pharmaceuticals, Inc. - 14 months ago