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Director, Technical Operations – Cell and Gene Therapy Manufacturing

Location: South San Francisco, CA

Company Description:

Ambys Medicines is a biotechnology company focused on discovering and developing regenerative and restorative therapies for people with advanced liver disease. Founded by world-renowned experts in liver disease and regenerative medicine, Ambys is pioneering the application of novel modalities including cell and gene therapy, and gain-of-function drug therapy, to meet the urgent need for treatments that have the potential to restore liver function and prevent the progression to liver failure across multiple liver diseases that are untreatable or poorly treated today. Ambys was launched in 2018 by Third Rock Ventures and Takeda Pharmaceuticals with $140M in starting capital and is headquartered in South San Francisco, Calif.

Position Summary:

We are seeking a talented and motivated Director of Technical Operations – Cell and Gene Therapy Manufacturing at Ambys. The individual will be responsible for the manufacture of novel cell and gene therapy products to treat patients with severe liver disease. This person should have extensive experience in process development, establishment of cGMP processes, manufacture and release of cell and/or gene therapies, and the design and management of cGMP facilities.  Strong candidates will be highly organized and have the self-confidence to work across boundaries to manufacture products for supporting IND-enabling and clinical studies. She or he will be responsible for organizing and executing technology transfer of cell and gene therapy product manufacturing processes and controls to our Contracting Manufacturing Organization (CMO) partners or to Ambys’ own manufacturing facility.  This individual will also be responsible for the design, construction, and management of this manufacturing facility.  Candidates should enjoy working in a fast-paced dynamic team environment and be motivated to develop new breakthrough therapies for patients with severe liver disease.

Job Requirements:

  • Define the manufacturing strategy for developing Ambys’ cell and gene therapy platforms suitable to support early- and late-stage clinical studies and then commercialization; work with senior management to ensure strategic direction aligns with corporate goals
  • Oversee the design, construction, and management of a complex GMP manufacturing facility, including hiring, training, managing facility requirements, and generation of development plans and budgets
  • Lead all elements of technical operations, process development, manufacturing, and supply chain resources to develop a scalable, cGMP-compliant process to manufacture hepatocyte cell therapies in support of preclinical and clinical studies.
  • Drive accountability by creating and articulating a clear plan of action aligned to the corporate and program objectives, guide daily activities of the team, and provide ongoing feedback at an individual and team level.
  • Oversee the selection and management of any Contract Manufacturing Organizations (CMOs) and all external partners to ensure competence, data integrity, and adequate supply of critical materials
  • Collaborate closely with other functions (e.g., Quality, Regulatory Affairs, R&D, Assay and Bioanalytical, and Clinical teams) to ensure successful program development; encourage cross-functional collaboration with peers to overcome challenges
  • Responsible for developing and managing timelines and ensuring development and tech transfer of processes occur in a timely manner
  • Responsible for establishing the necessary SOPs, batch records, reports, and IND sections for clinical translation and development of the cell and gene therapy platforms
  • Organize, communicate, and present complex data sets to senior management and key stakeholders

Qualifications:

  • BS or equivalent degree in bioprocessing, medical technology, chemical engineering, or biological sciences is required
  • 10 plus years of experience in the biotechnology or pharma industry with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products
  • 8 plus years of increasing responsibility in managing and leading a team of process development engineers and manufacturing teams
  • Experience with the set-up, technology transfer and execution of manufacturing processes and controls internally or at CMOs
  • Experience with the direct manufacture of cell and gene therapy products or management of technology transfer and subsequent manufacture of cell therapy products at CMOs
  • Expertise influencing across functions and teams to achieve organizational objectives
  • Experience preparing documentation for regulatory filings with US and EU regulatory agencies
  • Demonstrated technical and strategic leadership and problem-solving skills
  • Ability to work independently and as part of a team with exceptional ability to collaborate and lead
  • Experience presenting complex concepts to all levels of the organization, with proven ability to clearly articulate a point of view and recommendation
  • Ability to lead a team and mentor individuals to achieve organization, team and individual objectives while adhering to the company values (fearless, accountable, collaborative)
  • Expertise in staffing, budgeting and expense management
  • Proven project management capability with a track record of meeting timelines is required
  • Excellent written and oral communication skills to influence effectively across the organization and with CMOs

 

If you would like to be considered for an opportunity at Ambys Medicines, please submit your CV with the title of the position in the subject line to careers@ambys.com

The well-being of our employees and their families is important to us. We offer comprehensive and competitive health, financial, paid time off and many other benefits designed to promote the health and financial well-being of our employees and their families.

Note to Recruitment Agencies: Please do not forward any agency resumes. Ambys Medicines is not responsible for any fees related to resumes that are unsolicited.

Ambys Medicines is an equal opportunity employer.