Sr. Director, Analytical Development

Location: Emeryville, CA
Department: R&D Technology Development

POSITION SUMMARY

Quality is the primary guiding principle at Zogenix. It is the foundation on which all functions and activities are performed. Excellence in the management of quality is fundamental and the foremost aspect against which the Pharmaceutical Operations team are judged by our patients, caregivers, partners, colleagues, and regulatory authorities. Our commitment is to go beyond compliance and operate effective quality, development, operations, and supply systems that result in excellent products, processes, innovations, and documentation to ensure satisfaction from all stakeholders. We are committed to providing therapeutic solutions with potential to transform the lives of patients and their families living with serious rare diseases.

The Senior Director of Analytical Development is responsible for management of the analytical chemistry function and staff/contractors, design of CMC control strategy, and technical oversight of analytical and bioanalytical activities at CDMOs. The director will lead drug substance and drug product analytical and control strategy development throughout the development lifecycle, provide technical support for commercial activities, contribute to continuous improvement of quality systems, and efficiently design and execute early stage pipeline studies. The director also contributes to CMC regulatory strategy and authors analytical sections of regulatory submissions. The director’s role is collaborative as well as technical, as they partner internally with Formulation, Process Chemistry, Regulatory, Quality, Clinical Development, Clinical Operations, Clinical Supply, Nonclinical Development, Manufacturing, Technical Operations, and Market Access, and externally with CDMOs, consultants, and other scientific resources. The successful candidate will have direct and recent experience in US and EU pharmaceutical product development.

 MAJOR AREAS OF RESPONSIBILITY

  •  Accountable for design and execution of analytical development plans for preclinical to commercial programs including:
    • Design of control strategy and development/justification of material and product specifications
    • Oversight of method development and validation for release/stability testing, in-process analytical controls, and starting material/intermediate testing
    • Design and oversight of development studies for molecule/process/product characterization
    •  Management of the analytical component of formulation and process chemistry development and validation
    •  Management of and contribution to structural elucidation and characterization of impurities
    • Administration of stability programs and authorship of expiry updates
    • Authorship and review of technical reports and analytical sections of regulatory submissions
    • Oversight of GMP release and stability testing
    • Management of analytical tech transfer
    • Management of laboratory investigations
    • Contribution to manufacturing investigations
    • Adherence to internal and external regulatory (e.g. ICH, FDA, EMA, etc.) and GMP requirements
  • Coordination of analytical activities with formulation, process chemistry, manufacturing, quality, regulatory, and clinical supply functions
  • Contribution to regulatory negotiations including strategy for regulatory responses and consultation
  • Responsible for the quality of development studies, reports, and regulatory documents
  • Contribution to vendor selection including drug product and drug substance CDMOs and bioanalytical CROs
  •  Continuous improvement of quality systems including authorship and revision of SOPs and the design, justification, and implementation of lean control strategies to support fast-moving IMP programs
  •  Analytical support for method validation and troubleshooting at nonclinical CROs
  •  Management of bioanalytical method development and validation
  • Support of bioanalytical investigations for validation or clinical sample analysis
  • Review and publishing of bioanalytical PK reports
  • Coordination with bioanalytical CRO and Clinical Operations to develop bioanalytical sampling requirements
  • Analytical Development budgeting and resource management including CDMO proposals/invoicing as well as management of contractors and consultants

 MINIMUM JOB QUALIFICATIONS

  •  Ph.D. in analytical chemistry or related discipline with at least 12 years of relevant analytical chemistry experience and at least 3 years of team or project leadership experience
  • Expertise in contemporary analytical development for small molecule drug substances and drug products, experience in gene therapy development a plus
  • Strong communication skills
  • Fluency in relevant regulatory guidelines, including familiarity with current areas of regulatory focus and country-specific requirements
  • Experience in CDMO management and strong background in management of cGxP activities
  • Record of contribution to regulatory submissions

 PREFERRED JOB QUALIFICATIONS

  • Experience supporting all phases of pharmaceutical development from discovery to approval
  • Experience in the development of parenteral drug products and modified release oral drug products
  • Experience in analytical development of biologics
  • Experience in small molecule bioanalytical method development and validation
  • Ability to manage risk, overcome obstacles, anticipate challenges, and prepare contingency strategies
  • Demonstrated success working effectively outside defined scope of responsibility
  • Strong project management skills while maintaining high quality and efficiency standards

SPECIAL WORKING CONDITIONS

  • Must be willing to travel (some international) as required