Allakos Inc
Sr. Director, Analytical Development and Quality Control
Allakos Inc - Redwood City, California, United States, 94061
Work at Allakos Inc
Overview
- View job
Overview
Sr. Director, Analytical Development and Quality Control Join to apply for the
Sr. Director, Analytical Development and Quality Control
role at
Allakos Inc Sr. Director, Analytical Development and Quality Control 3 weeks ago Be among the first 25 applicants Join to apply for the
Sr. Director, Analytical Development and Quality Control
role at
Allakos Inc 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.
Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.
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.
Role
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther Referrals increase your chances of interviewing at Allakos Inc by 2x Sign in to set job alerts for “Senior Director of Development” roles.Director of Development and Sponsorships3168-Senior Director- M&A and Corporate Development San Francisco, CA $200,000.00-$250,000.00 1 month ago San Francisco, CA $90,000.00-$130,000.00 2 weeks ago Fremont, CA $200,000.00-$250,000.00 1 day ago South San Francisco, CA $192,000.00-$244,000.00 1 month ago Alameda, CA $185,000.00-$262,000.00 2 weeks ago Oakland, CA $159,000.00-$271,000.00 14 hours ago San Francisco, CA $148,000.00-$220,000.00 2 months ago San Francisco, CA $240,000.00-$285,000.00 4 days ago Director/Senior Director, Project ManagementDirector, Strategic Partnerships and Business Development San Francisco, CA $182,900.00-$228,600.00 2 weeks ago East Coast Director of Business Development, Grid Side Menlo Park, CA $191,000.00-$225,000.00 2 weeks ago Mountain View, CA $255,000.00-$344,500.00 1 week ago 3050 -Senior Director- Platform Strategy and Business Development San Francisco, CA $200,000.00-$250,000.00 1 month ago Mountain View, CA $175,000.00-$181,000.00 2 weeks ago Oakland, CA $144,278.00-$225,289.00 2 weeks ago Redwood City, CA $150,000.00-$185,000.00 2 months ago Menlo Park, CA $135,000.00-$150,000.00 2 weeks ago Director, Business & R&D Operations, Early Discovery San Jose, CA $115,000.00-$120,000.00 3 weeks ago Director of Corp Development and Investor Relations, FinanceSenior Director, Autonomous Business Development San Leandro, CA $150,000.00-$190,000.00 6 months ago San Jose, CA $152,500.00-$262,350.00 1 month ago San Francisco, CA $140,000.00-$360,000.00 17 hours ago San Mateo, CA $207,000.00-$297,000.00 6 days ago SENIOR DIRECTOR OF DEVELOPMENT - WEST COAST San Francisco, CA $112,513.06-$130,796.43 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Sr. Director, Analytical Development and Quality Control
role at
Allakos Inc Sr. Director, Analytical Development and Quality Control 3 weeks ago Be among the first 25 applicants Join to apply for the
Sr. Director, Analytical Development and Quality Control
role at
Allakos Inc 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.
Scroll down to find an indepth overview of this job, and what is expected of candidates Make an application by clicking on the Apply button.
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.
Role
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionOther Referrals increase your chances of interviewing at Allakos Inc by 2x Sign in to set job alerts for “Senior Director of Development” roles.Director of Development and Sponsorships3168-Senior Director- M&A and Corporate Development San Francisco, CA $200,000.00-$250,000.00 1 month ago San Francisco, CA $90,000.00-$130,000.00 2 weeks ago Fremont, CA $200,000.00-$250,000.00 1 day ago South San Francisco, CA $192,000.00-$244,000.00 1 month ago Alameda, CA $185,000.00-$262,000.00 2 weeks ago Oakland, CA $159,000.00-$271,000.00 14 hours ago San Francisco, CA $148,000.00-$220,000.00 2 months ago San Francisco, CA $240,000.00-$285,000.00 4 days ago Director/Senior Director, Project ManagementDirector, Strategic Partnerships and Business Development San Francisco, CA $182,900.00-$228,600.00 2 weeks ago East Coast Director of Business Development, Grid Side Menlo Park, CA $191,000.00-$225,000.00 2 weeks ago Mountain View, CA $255,000.00-$344,500.00 1 week ago 3050 -Senior Director- Platform Strategy and Business Development San Francisco, CA $200,000.00-$250,000.00 1 month ago Mountain View, CA $175,000.00-$181,000.00 2 weeks ago Oakland, CA $144,278.00-$225,289.00 2 weeks ago Redwood City, CA $150,000.00-$185,000.00 2 months ago Menlo Park, CA $135,000.00-$150,000.00 2 weeks ago Director, Business & R&D Operations, Early Discovery San Jose, CA $115,000.00-$120,000.00 3 weeks ago Director of Corp Development and Investor Relations, FinanceSenior Director, Autonomous Business Development San Leandro, CA $150,000.00-$190,000.00 6 months ago San Jose, CA $152,500.00-$262,350.00 1 month ago San Francisco, CA $140,000.00-$360,000.00 17 hours ago San Mateo, CA $207,000.00-$297,000.00 6 days ago SENIOR DIRECTOR OF DEVELOPMENT - WEST COAST San Francisco, CA $112,513.06-$130,796.43 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr