Lead Quality Control Microbiologist
POSITION OBJECTIVE: Responsible for validation, performance, and review of all aspects of analytical testing and environmental monitoring that takes place in the Microbiology department. Will also provide direct support to Microbiology Supervision in all relevant types of investigations and personnel planning.
This position is based on site in our Dunkirk, New York facility. Remote work is not an option for this role.
Essential Job Functions/Responsibilities
- Design, perform, review, and approve microbiology testing product validations (sterility, endotoxin, Microbial Enumeration) and clean room qualifications.
- Scheduling/assistance in scheduling of department Analysts and Technicians.
- Improve process and sample flows in the laboratory for more efficient material and personnel movements.
- Perform, review, approve (and provide results or extension by due dates) for laboratory investigations (LIR), issue reviews (ISSUE), discrepancy investigations (DIR), environmental excursions (EE), out of specification reports (OOS), and corrective action-preventative action reports (CAPA) in a timely manner.
- Provides oversight for Microbiology department functions included but not limited to: Media Fill program, Environmental Surveillance Team, ID/Trending Program, Excursion Investigations, providing audit response information, Lab supply system, and Gowning Program.
- Performance (if needed), review, approval of Sterility
- Performance (if needed), review, approval of environmental monitoring of ISO5/ISO7/ISO8 manufacturing areas (viable air, viable surface, and non-viable particulate) as well as inspection for compliance.
- Support Media Fill Validations, Engineering Validations and Cleaning Validations.
- Perform (if needed), review, and approve of testing (Bioburden/TOC/Conductivity) of water samples from throughout the facility.
- Perform (if needed), review, and approve of raw Material/Prefiltration Bioburden sample testing.
- Perform (if needed), review, and approve media check in, growth promotion, equipment preparation, autoclaving, preparation of microbial ID samples and off testing of incubated microbial media and plates.
- Oversight of stocking/ordering lab supplies.
- Revision of microbiology/laboratory procedures.
- Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
- May perform other duties as assigned.
Required Education & Experience
- Bachelor’s Degree in Microbiology/Biology or closely related field with a minimum of 4 years relevant experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
- Masters Degree in Microbiology/Biology or closely related field with a minimum of 2 years relevant experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
- Associates Degree in Microbiology/Biology or closely related field with a minimum of 5 years relevant experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
- May consider candidates with a High School diploma (or equivalent) with a minimum of 7 years relevant experience working in a microbiology laboratory in an FDA regulated biopharmaceutical /medical device industry
Required Skills & Abilities:
- Must successfully complete training on aseptic gowning procedures and demonstrate the ability to aseptically gown upon completion. (required)
- Accurate/legible completion of records and documents for tests performed, and accurate computer data entry.
- Experience in microbiological principles and applications related to microbial ID, validation, or clean room technology. (preferred)
- Use standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes, and water bath.
- Training in cGMP/cGLP for laboratory operations and compliance to regulatory guidelines with working knowledge of environmental monitoring, endotoxin testing, sterility testing, and/or Microbial Enumeration testing methods. (preferred)
- Proficient in the use of standard laboratory equipment including pH meter, balance, incubator, autoclave, pipettes, or water bath. (preferred)
- Training to ISO, USP or GMPs standards. (preferred)
- Technology Skills (Windows, Word, Excel, Power Point). (preferred)
- Ability to wear high level aseptic gowning with face mask for long periods of time (required).
- Ability to stand for long periods of time (required).
- Must have a valid driver’s license for travel to other Athenex locations as needed.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.