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Director, Partnership Development - Redwood City, CA, United States - Allakos
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Description
Director, Analytical Development and Quality ControlAllakos is committed to developing innovative therapies that transform patients' lives.
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
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 partnersIn 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., 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
~ 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
~ Excellent communication skills (interpersonal, written and verbal), and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
~ Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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