Headquartered in Pomona, California, Med-Pharmex, Inc. is among the leading developers and manufacturers of generic veterinary pharmaceutical products in the U.S. The Company markets over 25 FDA-approved products, all manufactured in one of its three FDA-approved, Pomona-based facilities, with multiple drug delivery systems such as injectables, suspensions, oral solutions, sprays, ointments, creams, pastes, and powders. Utilizing its expertise and experience in pharmaceutical product development in a cGMP environment, the Company's strength lies in its ability to continually innovate and develop products with high barrier entry, successfully navigate FDA regulatory requirements, and bring quality generic drug products to the veterinary market.Duties and Responsibilities:
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Direct laboratory operations in an organized and efficient manner to prevent any delays in product release.
- Defines and manages the activities of the Microbiology Laboratory to assure that all test samples meet the raw materials, intermediate, final product, and stability specifications.
- Provides expertise and troubleshoots microbiology related issues.
- Review and approves SOP, validation protocols, investigations, batch records, specifications as they relate to this department.
- Work with the Microbiology Supervisor to author Microbiology related deviations, CAPA, OOS and OOL investigations.
- Responsible for CGMP compliance of the laboratory and personnel.
- Define the development needs in the Microbiology Laboratory.
- Represent microbiology in meetings with Production, QA, Engineering, Regulatory Affairs and other related departments.
- Advises, recommends, and implements resolutions for quality problems and regulatory commitments to the Director of Laboratory Services, Validations, Production, and QA.
- Interact with other departments as required to define and/or verify the scope of work for a particular project; ie. Provide testing services for validation work.
- Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force.
Position type/Expected Hours of Work
Here at Med-Pharmex we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are:
- Education: B.S. in Microbiology/Biology or related field with 2-5 years of experience in management.
- Experience: B.S. with a minimum of 6 years, including 2 or more years of supervisory responsibilities (M.S. with 5-8 years, including 2 or more years of supervisory responsibilities) in Pharmaceutical or Biotechnology with emphasis in aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.
Med-Pharmex, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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