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.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Leading and directing the Microbiology department, providing hands-on guidance and support to ensure the team is successful in meeting their objectives.
- Developing and implementing learning and development opportunities for team members to enhance their skills and abilities.
- Making informed quality decisions related to non-sterile and Aseptic Processing across various areas such as manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.
- Ensuring timely initiation and closure of documentation related to deviations & investigations, CAPAs, change controls, SOPs, with standardized supporting documentation.
- Establishing and enforcing effective SOPs and training documents to promote consistency and compliance within the team.
- Oversees execution of testing including routine lot related analysis, environmental monitoring and raw material testing. Generation and approval of certificates of analysis for product release.
- Leads development, implementation, enhancement and maintenance of QC Microbiology systems.
- Evaluating QC Microbiology systems and recommending and/or implementing system improvements and CAPEX projects.
- Responsible for the QC Microbiology and Aseptic Techniques Training programs.
- Conducting laboratory investigations and writing reports for deviations, Environmental Monitoring excursions, and Out of Specification results.
- Oversee the Environmental Monitoring Program, reviewing EM data, EM excursion investigations and EM reports.
- Ensuring that development and implementation of testing programs meet departmental, company, and regulatory compliance requirements.
- Taking ownership of multidepartment projects (identifying tasks, assigning responsibilities and timelines, and ensuring timely completion of projects).
- Developing effective partnerships with other departments to facilitate problem solving and resolution of issues.
- Coordinates with operations and supply management team for scheduling and test material availability to meet production demand and timely delivery of finished goods to distribution.
- Provides guidance to subordinates to achieve goals in accordance with established company goals and objectives.
- Develop and maintain internal KPI’s to demonstrate department performance.
- Writing/revising test methods and SOPs. Writing and reviewing QC technical protocols and reports.
- Develops, revises and reviews investigations, SOPs, qualification/validation protocols and reports
- Manage QC files and Environmental Monitoring electronic databases.
- Evaluate electronic database systems for implementation into QC.
- Effectively communicates with other departments and/or internal groups.
The Ideal Candidate
- Master’s degree in Microbiology field with a minimum 5 years of cGMP QC Microbiology experience in a cell therapy/biotech/pharmaceutical setting is required.
- Excellent critical thinking and technical writing skills.
- Ability to work effectively and efficiently on independent tasks as well as to accept direction on given assignments or in a team environment.
- A minimum of 2 years of management experience including leading, motivating, and developing technical staff.
- 5 years Environmental Monitoring experience is required.
- Demonstrated ability to apply comprehensive understanding of QC guidelines, regulations, and current industry practices, including cGMPs and aseptic processing guidelines.
- GMP instrument qualification/validation experience.
- Experience with FDA cGMP 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.