Associate Director, QC
The Quality Control Analytical Director is responsible for direction of the GMP Quality Control laboratory providing analytical support to the Novato production site. This function performs Quality Control testing that supports manufacture and release and stability of drug substance, intermediates, and drug product from CHO cell and bacterial cell production platforms as well as viral vector platforms. In addition, testing support of Contract Manufactured materials is performed. This role is responsible for the management of the analytical testing in support of:
- Test and release of Bulk Drug Substance and Drug Product
- Test of stability samples.
- Testing and support for critical reagents and reference standards.
- Support of CMO testing.
- Product Complaint support
- Implementation of new analytical methods
This position reports to the Quality Control Site Head and is a member of the Site QC Leadership Team. The successful candidate ensures functional objectives are aligned with company goals and regulatory expectations.
- Provide technical expertise and leadership for the performance of analyses of Manufacturing and Clinical Manufacturing In-Process samples under cGMP to meet specified timelines.
- Directly supervise QC Staff.
- Collaborate with cross functional teams on key site and Global programs.
- Implement the concepts of Operational Excellence and deploy appropriate systems and processes to enable the efficient operation of a GMP laboratory supporting multiple platforms and modalities
- Critically analyze and assess data.
- Prepare protocols, summaries, and reports.
- Act as technical resource.
- Develop leadership of the group.
- Maintain the laboratory in an inspection-ready state.
- Direction of investigations.
- Author, review and approve documents such as standard operating procedures, protocols, reports and trackwise records
- Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance
- Lead and implement initiatives that add value to the QC and site operations
- Optimization, troubleshooting and lifecycle management of analytical test methods
- PhD with at least 4 years of experience in a relevant functional area
- MS. with at least 6 years of experience in a relevant functional area
- BS. with at least 8-10 years experience in a relevant functional area (at least 2 years in Quality Control).
- At least two years in a cGMP laboratory, Quality Control experience preferred.
- Demonstrate expertise with analytical methods used to assess biopharmaceutical products.
- Lean Labs and, Six Sigma, and 5S experience.
- Ability to work independently, managing projects and meeting established timelines.
- Comfortable with directing the activities of other staff members.
- Computer literacy is required. Experience with Laboratory Information Management systems (i.e., LIMS) is preferred.
The position requires some technical knowledge of the following areas:
- Immuno Assays
- PCR (Polymerase Chain Reaction) based assays
- Total Organic Carbon Analysis
- Basic analytical skills
- Direction and management of the managerial and supervisory leaders of the Analytical testing Quality control function. Typically, 4-5 direct reports.
- GMP Acumen
- Critical Thinking & Evaluation
- Organizational Awareness
- Performance Management