Associate 2, QC Contract Laboratory Management
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Associate/Associate 2 is a member of Quality Control team. This position reports to manager of Quality Control Contract lab management and will maintain responsibility, oversight and management of all QC contract testing related activities. Key responsibilities include:
- Organize QC contract testing and cell bank testing and production activities.
- Support and execute process improvement initiatives and efficiencies in relation to contract laboratory testing and cell bank procedures.
- Generate, revise and maintain Quality Technical Agreements (QTAs) with contract testing labs and contract cell bank manufacturers.
- Provide updates on contract testing status to management and QC lab clients.
- Attend meetings as QCCLM representative and provides and inputs.
- Represent at Quality Partner Team (QPT) meetings and provide inputs and updates as necessary.
- Prepare and report monthly summaries of contract laboratory activities and metrics.
- Establish effective communication and collaborative relationships with internal functional groups and maintain positive relationships with contract testing lab partners.
- Prepare memos for cell bank stability monitoring for inclusion in Annual Product Review report.
- Support regulatory filing requests and provide input to regulatory submissions.
- Support onsite regulatory agency, partner and QP inspections.
- Plan and organize contract testing and cell bank testing/production activities.
- Take the initiative to create, optimize and improve QC contract testing management systems.
- Execute plan for developing secondary testing labs for each functional QC contract testing.
- Develop training modules of QC contract assays.
- Assist evaluating performance of contract testing labs and cell bank manufacturers.
- Provide quarterly updates on contract testing and cell bank testing/production activities.
- Oversee the progress of assay training and assay transfer activities at contract testing labs.
- Lead effort to generate and/or revise Quality Technical Agreements with contract testing labs and contract cell bank manufacturers.
- Generate MSA (Master Services Agreement), SOW (Scope of Work) in Spring PM system owned by Legal department.
- Generate purchase orders in iProcurement system for contract testing and cell bank testing/production.
- Generate BioMarin CofA for new cell bank production.
- Communicate and facilitate atypical, deviation, OOT and OOS results investigation between contract testing labs and BioMarin QC department.
- Represent QC Contract lab management and participate in multi-departmental meetings.
- Forecast and assist cost center budget planning.
- Audit contract testing labs with compliance group as necessary.
- Manage and maintain good relationships with contract testing lab partners.
- Support regulatory filings.
- Support regulatory agency, partner and QP inspections.
- Other duties as required.
Qualifications / Requirements:
- At least five years in a cGMP laboratory; quality control experience required.
- Well-developed laboratory skills for analysis of pharmaceuticals, biopharmaceuticals.
- Demonstrated ability to perform most tasks with limited supervision: general instructions on routine work, detailed instructions on new assignments.
- Good computer literacy.
- Excellent organizational and project management skills.
- Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
- Thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
- Good written and verbal communication skills
- B.S./B.A. degree with at least 8 years of experience in a pharmaceutical industry.
- 5-6 years in Quality Control laboratory. M.S. degree with at least 5 years of GMP laboratory experience.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.