Associate Director, Product Development and Manufacturing Pharma
ChemoCentryx Inc San Carlos, CA
- Expired: over a month ago. Applications are no longer accepted.
ChemoCentryx is searching for an Associate Director, Product Development and Manufacturing Pharmaceutical Development Technical Operations that will be responsible for the development and overseeing the execution of strategies in support of the development of product in support of all phases of clinical development and product commercialization. This role will report to the Senior Vice President, Technical Operations and work out of our brand new state-of-the-art corporate center in San Carlos, CA.
Working with internal functional partners, external contract development organizations and selected consultants, The Associate Director is essential in supporting the development of drug product including scale-up and development of manufacturing, packaging and serialization of commercial products by the Contract Manufacturing Organizations (CMOs). This role is a critical member of the cross-functional team and working with Clinical Development and Clinical Operations on the development and execution of strategies in the design of the clinical product.
Essential Duties and Responsibilities
- Partnering with product development, management and other internal partners, establish and track progress in the execution of the technical drug product strategies in support of NDA / MAA filings, product approvals and commercialization. Responsible from IND, Phase 1, 2, 3 to NDA filing and approval and during the commercialization
- Providing project management and technical expertise to late phase Chemistry Manufacturing Control (CMC) activities, in particular those activities associated with drug product manufacturing, packaging and release
- Performs CMC technical audits and CMO audits to ensure technical capabilities and compliance with relevant regulations
- Technical expertise to all the Good Manufacturing Practice (GMP) activities associated with the outsourcing of the development and manufacturing of drug product for all phases of development
- Overseeing the manufacture of clinical trial and commercial materials at the selected CMO. Facilitates the design and implementation of initiatives with the CMOs that improve business performance
- Provides technical support to Supply Chain and Quality in resolving issues associated with the manufacturing, packaging and release of commercial products; support for the oversight of site technical validation activities (analytical, manufacturing, etc.)
- Closely partner with Quality Assurance (QA) in the review and approval of batch record, validation, specification and change control documentation produced by CMOs and Contract Research Organizations (CRO) for all development programs
- Partner with Product Development management and QA, oversee the CMOs and CROs performance associated with the investigations, effective closing of all deviations and ensures that robust corrective actions are identified and quickly implemented
- Collaborating with the Company’s Quality Organization, establishes, oversees, expands and maintains a Standard Operating Procedure (SOP) related to Pharmaceutical Development
- Authoring of Drug Product Sections of all regulatory documents. Assists in the review of pertinent technical sections of the regulatory submissions for USA and worldwide health agencies
- Principal author of Contract Manuals and key contact with the CMO for their implementation and update
- Collaborate in the creation, maintenance and updating of the departmental yearly budge
- Master’s degree or Ph.D. in scientific field with 10+ years of technical and direct product development and strategic planning experience for late stage Product Development and during product commercialization
- Experience in authoring the Common Technical Document sections as they relate to drug substance, drug product, analytical chemistry and specification settings in support of IND’s, NDA’s, MAA’s and IMPD’s
- Experience as it relates to managing and interaction with CMOs from early through late drug product development
- Experience, knowledge and skills with compliant Quality Management Systems in support of Product Development and the Company’s business overall
- Deep knowledge of the GMP regulations requirements in product development manufacturing and release of clinical and commercial products
- Strong regulatory compliance working knowledge including Food and Drug Administration, Current Good X Practice (cGXP), etc.
- Detail oriented with excellent prioritization, organizational and project management skills, analytical / problem solving skills and communication (written / verbal) skills
- Able to travel up to 30%
- Commercial experience
- Drives and follows up the closure of action items from both team and business review meetings
- Experience in developing and implementing action plans to ensure readiness for regulatory and audit inspections
- Support project management in all technical activities associated with all development programs and product in commercialization
- Technical support experience during external audits of vendors and subcontractors
At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.
ChemoCentryx IncWhy Work Here?
At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry.
ChemoCentryx is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives. At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.
355 Industrial RoadSan Carlos, CA
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