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 quality systems for raw material sampling and testing; initiation of stability programs; qualification of the sterility test area, etc.
Assist the QC Manager in the day to day operations of the microbiology laboratory
Responsible for management of the quality control laboratory including microbiology testing (sterility testing, bioburden, endotoxin, and microbial identification); assure timely calibration of equipment/instruments
Supervises the activity of direct reports by scheduling assays, personnel and equipment to ensure timely completion of routine testing and special projects.
Review/approval of microbiological 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 , e nsure laboratory compliance
Monitor results for trends; perform laboratory investigations as required; implement CAPAs as needed.
· BS degree in Microbiology, Biology or related scientific field
· 5+ years’ relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing required.
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 microbiology 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