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.
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 a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer. Our mission is to become a global leader in bringing innovative cancer treatments to the market and improve health outcomes. To achieve this, we have assembled an experienced leadership team and have established global operations across the pharmaceutical value chain.
We have internalized our commercial infrastructure and supply chain, which we believe will enable us to capture greater shareholder value and minimize supply chain risk for our proprietary oncology drugs. Our US-based commercial sales and marketing team continues to grow as we prepare for the commercial launch of our oncology products, and we believe that our high potency oncology manufacturing facilities will create value by minimizing supply chain disruptions.
Our leadership team was carefully assembled to capture the global commercial market opportunities in novel drug development. Our executive officers are seasoned leaders with complementary skill sets across global pharmaceutical R&D, operations, supply chain and manufacturing, capital markets, and mer...gers and acquisitions. We believe we will be able to utilize this strength to create long term value for cancer patients, our employees and our shareholders. Our team is driven by the prospect of creating new paradigms in the treatment of cancer.