BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Director, Analytical Development and Quality Control to work for a leading San Diego County biotechnology company.
Director, Analytical Development and Quality Control
The Director, Analytical Development and Quality Control is responsible for the overall management and coordination of AD and QC work supporting company projects, including the management of deliverables, adherence to budget, and ongoing risk mitigation. The Director will identify or work with Research and external parties as a source of test methods, identify and manage external activities, and build and manage in-house analytical development capabilities. The Director will work with QA and Regulatory departments to assess requirements for assay qualification and validation, deliver suitable assays, and manage technical transfer for GMP assays to outside Contract Testing Laboratories (CTLs) for GMP release and stability testing. The Director must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity. The position reports to the Vice President, Technical Operations.
Drive AD and QC planning, development and execution of timelines to meet project goals, working with project team and project managers
Execute and control AD and QC project activities, including scope, schedule, budget and risk associated with each project.
Represent AD and QC status and strategy to management, other company departments, partners and regulatory agencies
Hire and manage staff as needed, consistent with corporate strategy on outsourcing vs. internal activities
Train staff in GMP compliance, industry best practices and regulatory expectations
Assess and define requirements for test methods to meet product development objectives, consistent with regulatory requirements. Work with QA, Regulatory, Manufacturing, Project Management and other company groups to ensure that AD and QC activities are appropriate for project goals and fully communicated.
Identify suitable external resources for assay development, which may include contract testing labs, partners, or company research affiliates. Develop contingency plans for mission-critical activities.
Establish working relationships with CTLs. Work with management and legal support team to establish Master Service Agreements, Protocols, Statement of Work, Quality Agreements and other contracts covering necessary activities and deliverables to meet project goals.
Oversee development, implementation, validation and ongoing management of robust assays by external CTLs. Assess completeness and scientific validity of effort. Work with vendors to obtain suitable technical development reports and documentation of cGMP activities. Support tech transfer to CTLâ€™s as needed.
For product characterization methods, supervise the development of appropriate methods, the testing of non-clinical and GMP materials, and the production of suitable test results and reports as needed.
Assist with development and implementation of appropriate test methods, reference standards and controls, and specifications for raw materials, process intermediates, drug substance and drug product.
Support Research including selection of cell lines for development candidates, by providing analytical support and interpretation.
Review test data from internal and contracted analytical activities. For cGMP activities, review and evaluate the suitability of test data to support product release, investigations, comparability studies, material review boards, etc.
Develop a stability strategy for clinical lots, work with CTLs to implement stability testing, develop stability specifications, and manage all stability programs.
Assess test methods for stability indicating properties including degradation pathways to enable setting of expiry/retest dates.
Write CMC sections of regulatory filings describing the above activities, as needed.
At least an MS degree in a relevant scientific discipline such as Biochemistry is required. A PhD is preferred.
At least 8 years of experience developing assays supporting biological products for human use, within a pharmaceutical or biotechnology firm. Experience working in a contract development organization is also relevant.
Experience with management of QC departments and CTLs performing GMP release and stability testing is required.