Sr. Director, Analytical Development and Quality Control

Position: Sr. Director, Analytical Development and Quality Control

Location: Redwood City, CA

Job : 273-1159

# of Openings: 1

Sr. Director, Analytical Development and Quality Control

Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory, and proliferative diseases.

Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.

As a member of the Allakos team you will have the opportunity to provide direction and oversight of technical activities associated with methods development, qualification, and validation in support of development of Allakos’ biologics therapeutics targeting eosinophil and mast cell-driven diseases. You will also oversee the outsourced DS and DP release and stability testing. The position reports to the SVP of Technical Operations and is based in Redwood City, CA office.

• Provide technical leadership and guidance across CMC development disciplines to all outsourced analytical methods and testing activities by providing clear objectives for multiple CDMO partners, assess all experimental plans and results, and coordinate future work to achieve desired development and manufacturing expectations
• Scope of technical responsibilities include bioanalytical and analytical methods development and transfer, qualification and validation, and stability studies
• Build collaborative relationships across functional areas to translate research and clinical program objectives into aligned, clear, and fit-for-purpose CMC objectives and milestones
• As an experienced CMC leader, provide options and contingencies to overcome technical challenges, timeline limitations, or changes to program goals
• Develop strong relationships with external CDMO partners to establish and manage appropriate scopes of work, and to ensure all activities are within program expectations
• Provide succinct and pertinent communication of program CMC status, priorities and pending activities, verbal and written, across company functional areas and to senior leadership
• Support, in collaboration with Quality and Regulatory, selection of strategic CDMO, manufacturing, analytical, and packaging partners, initially focused on early-stage programs. Negotiate, obtain, and review for accuracy legal and corporate approval for service agreements and related statements of work for development activities with external partners
• In collaboration with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials handling, and documentation;
  Ensure these Quality standards are followed at CDMOs
• Work with Regulatory, QA and Senior Management to ensure that all company policies are followed, and all external manufacturing activities comply with relevant regulations
• Support creation and/or review of CMC sections of regulatory submissions (i.e. IMPD/INDs/NDA), and responses to regulatory agency correspondence (i.e., FDA, EMA, etc.).

• 15 + years of pharmaceutical development experience with at least 5 years of CMC team leadership in the biotechnology or pharmaceutical industry. Advanced Degree in Analytical Chemistry, or Pharmaceutical Sciences
• Successful track record in leading CMC activities through transition from research to clinical studies, Ph1 to registration
• Technical expertise in analytical process and product characterization and stability of biologics
• Thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development and manufacture, and stability
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions
• Proven leadership and cross-functional management of multiple CMC programs. Track record of successfully driving and managing programs, overcoming challenges and risks
• Demonstrated ability to work effectively in a…