Sr. Director, Analytical Development and Quality Control
Allakos, Redwood City, California, United States, 94061
Position:
Sr. Director, Analytical Development and Quality Control
Location:
Redwood City, CA
Job Id:
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.
Position Summary 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.
Your Role
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.).
Qualifications and Expertise
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 fast-paced, team-oriented environment
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)
Must be well organized, proactive, and detail-oriented
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. 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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Sr. Director, Analytical Development and Quality Control
Location:
Redwood City, CA
Job Id:
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.
Position Summary 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.
Your Role
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.).
Qualifications and Expertise
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 fast-paced, team-oriented environment
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)
Must be well organized, proactive, and detail-oriented
The salary is competitive and commensurate with experience and qualifications.
The Allakos Values are: Selflessness, Drive, Clarity, Thoughtfulness, Fun, and Leadership
Allakos is an equal opportunity employer. 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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