Director, Analytical Development and Quality Control
Technical Operations | Mountain View, CA | Full Time
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.
As a clinical-stage company with a broad portfolio in multiple therapeutic areas, ChemoCentryx pushes beyond “good enough” and strives for a totally new way of healing.
Responsible for leading the development, qualification and validation of analytical methods supporting all phases of the product development. The scope of the work includes Regulatory Starting Materials, Raw Materials, Intermediates, Drug Substance and Drug Product.
Essential Duties and Responsibilities
- Oversees all the stability programs supporting all phases of Product Development and Commercialization.
- Responsible for the development and implementation, in conjunction with Quality Assurance and Supply Chain, of a strategy regarding release of commercial API and Drug Product including CMO data review and documentation.
- Responsible for the management of the Reference Standard Programs to secure their availability at the Contract manufacturing Organizations
- Principal member of ChemoCentryx multifunctional team in charge of the development and implementation of periodic Business Review Meeting. Responsible for the collection and presentation of QC data in support of performance metrics and remediation strategies.
- Oversees, the CMOs and CROs performance associated with the investigations and effective closing of all deviations. Working closely with our partners and with the Quality Assurance, Supply Chain and SME’s ensures that robust corrective actions are identified and quickly implemented.
- Responsible for the on-time approval of the documentation associated with the cGMP activities within the Analytical and Quality Control Organization
- Responsible for the periodic review of analytical methods performance across all the CMO’s QC laboratories and develop applicable remediation strategies.
- Responsible for the review and principal approver of cGMP documents including detailed review of analytical methods, their level of qualification supporting the proposed or approved specifications.
- In conjunction with Quality Assurance and Subject Matter Experts monitors audits of clinical and commercial production in particular the QC laboratories.
- Working closely with the Quality and Supply organizations supports compliant Quality Management System is further developed and maintained in compliance with applicable company and US/worldwide regulatory requirements, standards, guidance and procedures.
- Working with Quality Assurance, Supply chain and other ChemoCentryx departments leads continuous improvement efforts supporting analytical development activities and controls.
- Develops and execute on analytical development plans in support of proposed and/or approved specifications to ensure readiness for regulatory filings and audit inspections.
- Ensure that all analytical method validation packages are evaluated as changes occur based on Continuous Process Verification or because of Regulatory feedback. In case of requirement for changes to the methods, the Director leads the development and implementation of any strategy for execution of any applicable supplemental method validation
- Assists in the preparation and review of regulatory submissions for USA and worldwide health agencies including commercial product annual review report and submission
- BS, MS or PhD degree in Analytical Development, Chemistry, Pharmaceutics or related discipline
- At least 13 years of direct Analytical Development and QC experience supporting the developing and commercialization of pharmaceutical products
- Good understanding of the phase approach quality and requirements including analytical development and specifications supporting Product Development and Commercialization
- Deep knowledge and experience on the regulations supporting pharmaceutical development and commercializing of products
- Good understanding of the different phases of the product development including requirements of RM’s, API, Analytical Development/Stability and CTM for each phase of development
- Proven track record in strategic planning and execution for late stage development programs and in support of commercial product manufacture, release
- Must have strong regulatory compliance knowledge including FDA, cGXP, etc.
- Experience in conducting jointly external audits of vendors and subcontractors
- Must be detail oriented with excellent prioritization, organizational and project management skills
- Superior analytical, problem solving and reviewing skills
- Effective communication (written and verbal) skills
- Ability to travel up to 30%
- Must possess excellent leadership and communication skills