Manager/Sr. Manager Manufacturing

Manager/Sr. Manager Manufacturing

Santa Monica

Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the paradigm of treatment for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

We are seeking a highly motivated individual for the role of Manager or Sr. Manager, depending on experience, for Manufacturing, to work in an exciting new area of cell therapy at Neogene Therapeutics. This role reports directly to the Head of Global Manufacturing.

Responsibilities include, but are not limited to:

  • Lead and manage activities to enable GMP readiness for clinical manufacturing including equipment procurement, installation and qualification, facility qualification and technology transfer.
  • Develop Standard Operating Procedures (SOPs) for manufacturing processes
  • Provide oversight for GMP production activities and troubleshoot manufacturing issues as they arise.
  • Develop and execute procedures for the transfer of materials into the cleanroom and distribution throughout the suites.
  • Ensure all materials and equipment are identified and available in time for manufacturing activities.
  • Lead quality investigation documentation and resolutions.
  • Develop and revise manufacturing training requirements as needed.
  • Develop and implement programs to drive operational excellence towards right first time and on-time delivery.
  • Support capacity planning for clinical/commercial manufacturing
  • Review and monitor in-process, cell product release and characterization data to support lot release.
  • Partner with Process Development to align manufacturing plans with overall product development plans.
  • Ensure that all production operations are controlled and executed within GMP regulatory guidelines.
  • Provide for the identification and development of talent both within the team and across the site.
  • Support regulatory document development.
  • Provide timely verbal and written updates to Manufacturing leadership.
  • Other duties and projects as assigned to meet business needs.

Requirements:

  • Minimum required education/experience for BS + 7 years, for MS +5 years or for PhD + 2 years.
  • At least 5 years of pharmaceutical or biotech industry experience in increasing levels of responsibility and operational excellence or Lean manufacturing principles
  • Minimum of 5 years of people management experience
  • Clear understanding of GMP process and knowledge of CMC regulatory framework for biologics.
  • Experience of aseptic techniques for primary human cell cultures and GMP manufacturing.
  • Direct experience supporting tech transfer and GMP clinical/commercial manufacturing operations.
  • Experience with single use technologies and tools for cell culture
  • Organization skills for day-to-day activities and excellent communication and interpersonal skills.
  • A strong work ethic and sense of purpose with a demonstrated ability to identify, analyze and solve problems.
  • Ability to drive safety, quality, functional, technical, and operational excellence.
  • Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
  • Ability to make timely decisions and knowing when to escalate and when to delegate
  • Proficient understanding and application of principles, concepts, practices, and standards.
  • Wide range knowledge of industry practices, cell therapy manufacturing experience highly desirable
  • Develop solutions to complex problems independently
  • Refer as necessary to established precedents and policies or use original thinking.
  • Work is performed under minimal direction.
  • Assists in determining objectives of assignment.
  • Plan schedules and arranges own activities in accomplishing objectives.
  • Work is reviewed upon completion for adequacy in meeting objectives.
  • Provides support to upper management and accomplishes tasks mainly through direct supervision of entry-level exempt employees.
  • Provides direction to subordinates based on general policies and management guidance.

We offer the opportunity to join a highly dynamic growth-stage biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.

If you are interested, please submit your electronic application including cover letter and CV to careers@neogene.com

No recruiters. No phone calls.

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