SanFranRecruiter Since 2001
the smart solution for San Francisco jobs

Associate Director, Drug Substance Contract Mfg Site Manager - Job #10

Company: Allakos, Inc.
Location: Redwood City
Posted on: February 16, 2020

Job Description:

As a member of the CMC Supply Operations Management team within Technical Operations at Allakos, this person will be accountable for overseeing all activities in the company's drug substance (DS) contract manufacturing network. Will lead cross-functional teams and support the processes and systems to ensure exceptional quality and reliability throughout the external drug substance manufacturing network. This includes developing a CMO strategy, managing the business relationship, ensuring the successful supply of product and achieving operational and business goals. He/She will lead DS product changes, investigations, process improvement and risk mitigations. This position reports to the Exec. Director of CMC Supply Operations. Responsibilities

  • Accountable for the overall performance of our drug substance CMOs
  • Provide leadership, management, and instruction to external manufacturing sites to ensure the company's clinical / commercial supply and operational / project goals are met promptly and exceptionally.
  • Drug substance CMO partner for company within the CMC Supply Operations group.
  • Responsible for organizing and leading the company's cross-functional teams which work with the CMOs including Quality, Regulatory, Finance, Technical Operations, Legal, Clinical, Commercial and Business Development.
  • Facilitates the identification, prioritization, planning and execution of a broad range of medium to complex technical projects. Ensures successful and timely completion of deliverables. Owns planning and execution of technical changes that have regulatory and/or multi-site impact.
  • Develops and maintains project plans for key DS related deliverables. Leads risk identification and mitigation activities. Proactively identifies and tracks issues and drives their resolution.
  • Ensures the CMO executes the production plan to deliver an uninterrupted supply of clinical and commercial product. Identifies supply constraints and leads timely resolution of issues. Monitors production campaigns and reports on CMO's performance against plans.
  • Point person to manage the Allakos / CMO relationship including negotiation of improvement plans to address performance or contractual issues.
  • Ensures CMO project plans are aligned with overall Allakos plans for regulatory filings and other key initiatives.
  • Ensures that corporate safety, health and environment (SHE) and Quality audits are performed, and mitigations plans are in place for the CMO to comply with terms of agreements, corporate group policy and local legal requirements.
  • Reviews commercial supply and quality agreements. Forecasts CMO budget and gains approval. Controls cost to ensure the CMO Site is within approval budget.
  • Travel domestically and internationally up to 15% of the time. Qualifications:
    • At least 15 years of experience (12+ with MS, 10+ for PhD) successfully working in an operations environment, with at least 8 years managing cross functional projects.
    • Experience working with Contract Manufacturers is required with overall knowledge of biologics Drug Substance commercial manufacturing in a cGMP regulated environment. Monoclonal Antibody Experience highly desired.
    • Previous experience in technology, quality and/or supply chain roles is preferred.
    • Certification in Project Management (i.e. PMI certification) or additional relevant management training is preferred.
    • Previously worked with cGMP-regulated environment including relevant
    • US/EU regulatory and quality requirements, practices, and standards.
    • Exceptional interpersonal skills to establish positive relationships with internal stakeholders, CROs/CMOs, and multi-functional/multi-cultural teams. The salary is competitive and commensurate with experience and qualifications. Interested applicants please send resume to and reference Job#1023Allakos 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.
      • Working at Allakos
      • Open Positions
        • Administrative Support - 1022
        • Associate Director, Drug Substance Contract Mfg. Site Management - 1023
        • Associate Director, Packaging Contract Mfg. Site Management - 1028
        • Clinical Documentation Assistant - 1011
        • Clinical Trial Assistant (CTA) - 1010
        • Data Analyst / Senior Data Analyst - 1033
        • Director, Commercial Manufacturing - 1037
        • Field Medical Scientist Job based in Northeast United States - 1025
        • Field Medical Scientist Job based in South/Southeast United States - 1026
        • Head of Human Resources - 1031
        • HR/Talent Acquisition Representative - 1029
        • Manager - QC Technical Support - 1016
        • Senior Manager of Clinical Data Management - 1013
        • Sr. Manager/Associate Director, Project Management and Medical Affairs Operations - 1020
        • (Senior) Medical Director, Medical Affairs - Allergy/Gastroenterology - 1035

Keywords: Allakos, Inc., San Francisco , Associate Director, Drug Substance Contract Mfg Site Manager - Job #10, Executive , Redwood City, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Project Manager
Description: Hello, Title: Project Manager Location: Sunnyvale, CA Duration: 6 Months Onsite only - M-F Applied Machine Learning Looking for someone who has experience in Leading/ Managing Machine Learning ML (more...)
Company: Advent Global Solutions, Inc.
Location: Sunnyvale
Posted on: 02/28/2020

Registered Nurse Case Manager RN - Home Health and Hospice - Full Time
Description: Job Description:Description Heartland Home Health Care and Hospice is part of the HCR ManorCare family, a leading provider of home health care, hospice care, skilled nursing, memory care and post-acute (more...)
Company: Heartland Hospice
Location: San Rafael
Posted on: 02/28/2020

Pain Management Physician (St. Joseph Health Medical Group)
Description: Job ID Number: 8037 Facility Name: St. Joseph Health Medical Group Location Name: Santa Rosa, CA Brand Name: St. Joseph Health Provider Profession: Physician/Surgeon Medical Specialty: Pain Management (more...)
Company: St. Joseph Health
Location: Santa Rosa
Posted on: 02/28/2020

Assistant Branch Manager - Campbell, CA
Description: Job Description:A Fidelity Assistant Branch Manager partners with senior management to lead a team of successful sales and service associates, as they prepare to run their own branch. Your visionary spirit (more...)
Company: Fidelity Investments
Location: Sunnyvale
Posted on: 02/28/2020

Revenue Operations Sr. Manager
Description: Are you an enthusiastic, talented, and experienced Revenue Operations Manager with a passion for growing RTI's sales initiatives Does the chance to partner with sales leaders and develop business strategies (more...)
Company: Real-Time Innovations
Location: Sunnyvale
Posted on: 02/28/2020

Digital Product Management
Description: 201 Third Street 61049 , United States of America, San Francisco, CaliforniaAt Capital One, we're building a leading information-based technology company. Still founder-led by Chairman and Chief Executive (more...)
Company: Capital One
Location: San Rafael
Posted on: 02/28/2020

Budget and Resource Planning Manager
Description: Job Summary: br br Under direct supervision of the Vice President-Strategy, Innovation and Operation, the Manager ensures the strategic objectives of Samuel Merritt University are supported by the (more...)
Company: Samuel Merritt University
Location: Oakland
Posted on: 02/28/2020

Property Manager
Description: Looking for a fully qualified and experienced residential property manager in Merced, California.
Company: Real Property Management Valley Wide
Location: Modesto
Posted on: 02/28/2020

Controllers and Tax Services - Vice President
Description: DescriptionDo you want your voice heard and your actions to count Discover your opportunity with Mitsubishi UFJ Financial Group MUFG , the 5th largest financial group in the world as ranked by S P Global, (more...)
Company: MUFG Union Bank
Location: Oakland
Posted on: 02/28/2020

Marketing Budget Manager
Description: Are you data-driven We at NetApp believe in the transformative power of data - to expand customer touchpoints, to foster greater innovation, and to optimize operations. We are designed for simplicity, (more...)
Company: NetApp
Location: Sunnyvale
Posted on: 02/28/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Francisco RSS job feeds