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Director - Head of Upstream CMC & Process Development

Company: NGM Biopharmaceuticals, Inc.
Location: South San Francisco
Posted on: May 3, 2021

Job Description:

NGM Biopharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering and developing the next generation of medicines for the treatment of serious diseases. Our experienced scientific team has joined forces with an impressive group of industry professionals, Nobel Laureates and other distinguished researchers to build a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine that has a track record of generating one new IND candidate per year. NGM's current pipeline of clinical-stage programs consists of five drug candidates targeting liver and metabolic diseases, retinal diseases and cancer. The most advanced drug candidate, aldafermin (NGM282), is in Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH) and is wholly-owned by NGM. Another drug candidate, NGM621, is in a Phase 2 study in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). NGM's strategic collaboration with Merck, with a current term running to March 2022, provides us with the resources and flexibility to pursue our ambitious R&D goals and further extend our pipeline of novel drug candidates.

NGM currently has a leadership position open in our CMC team. The team is responsible for progressing NGM's cutting edge science derived protein based therapeutics. As the Head of Upstream CMC & Process Development, the candidate will provide oversight for upstream technical activities from process development to cGMP manufacturing at CMOs in support of accelerated Phase 1 development and late stage development/commercialization. In addition, the candidate will drive the development and optimization of an in house upstream platform process at NGM. The position requires in-depth knowledge of mammalian and bacterial cell culture process development and cGMP manufacturing. Successful candidate shall be an accomplished technical leader with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.

Responsibilities

  • Lead the upstream process development function, responsible for all aspects of CMC upstream. Provide technical oversight on all upstream related activities including process development, process transfer, process characterization/validation, and cGMP manufacturing
  • Drive and oversee tech transfer, Tox material production and cGMP clinical material manufacturing at CMO sites
  • Set effective upstream development and manufacturing strategies using current state of the art biomanufacturing technologies and approaches in support of both early phase and late phase development programs. Prepare upstream CMC group to support commercialization and BLA preparation activities.
  • Lead upstream group to develop in-house mammalian cell culture platform process. Ensure scientifically sound approaches for studies performed both in-house and at CMOs
  • Manage and guide members of the USP CMC group, to ensure delivery of technical objectives, effective collaboration and career development for each group member; manage resourcing of projects and project assignments of group members.
  • Author and review protocols, technical reports, batch records, SOPs and CMC sections of regulatory submissions
  • Conduct root cause investigations and identify solutions to resolve upstream related issues and manufacturing deviations
  • Design studies and interpret results of development, troubleshooting and process characterization experiments
  • Collaborate effectively with other CMC functions including cell line development, downstream, formulation and analytical areas.
  • Serve as a strategic partner and member of CMC leadership team
  • Potential to lead cross functional CMC project teams & lead strategic CMC decisions for development programs
  • Communicate and collaborate with key stakeholders from QA, Regulatory Affairs, Clinical Development within NGM and with CMOs and CROs to achieve project goals and timelines

Required Experience

  • Ph.D. in Chemical Engineering, Biotechnology or other relevant life science disciplines with more than 10 years relevant experience including people management. Candidates with M.Sc. or B.Sc degree will also be considered with sufficient industry experience and demonstrated ability to lead a broad USP scope
  • In-depth knowledge in mammalian and bacterial cell culture process development and manufacturing science is required
  • Knowledge and broad understanding of the cGMP requirements and relevant regulatory guidelines, including requirements for upstream and cell bank manufacturing and testing
  • Experience participating in and leading cross functional teams such as CMC teams
  • Strong collaboration, communication, and strategic skills including ability to deal with ambiguity and to lead through change. Demonstrated ability to work in a fast-paced environment, to multitask, and to manage multiple projects
  • Ability to independently and rapidly make decisions based on data, scientific knowledge and sound judgement
  • Proficiency in leading process characterization/validation and BLA preparation/commercialization activities
  • Ability to travel and to engage with global partners

NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, employee stock purchase program participation, 401(k) and a comprehensive, industry-leading, benefits package.

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Keywords: NGM Biopharmaceuticals, Inc., South San Francisco , Director - Head of Upstream CMC & Process Development, Other , South San Francisco, California

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