NGM Biopharmaceuticals, Inc. is a clinical stage biotech 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 form a company where innovation and cutting-edge science has provided the foundation for a robust drug discovery engine. To date, NGM Bio has generated a pipeline of seven drug candidates in various stages of development targeting liver, metabolic and ophthalmic diseases and cancer. The most advanced drug candidate, NGM282, is entering Phase 2b clinical studies in non-alcoholic steatohepatitis (NASH). NGM’s strategic collaboration with Merck, which was extended to March 2022, will continue to provide 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 senior level project management position open in our CMC team. The team is responsible for progressing NGM’s cutting edge science derived protein based therapeutics. As a Director/Associate Director of CMC Project Management, the candidate will provide critical support activities to multiple fast-moving development projects, including both accelerated Phase 1 development and late stage development/commercialization programs. The major activities include planning of timelines and budget, tracking of execution, facilitating communications within the team and externally, escalation of issues and knowledge management. There are regular interactions with multiple CMOs, CROs and consultants. The position also works closely with other project managers, finance, clinical operations, quality and regulatory affairs. The position requires working knowledge of mammalian cell culture process development and cGMP manufacturing workflows and practices. Experience with supply chain management is desirable. Successful candidate shall be an experienced technical project manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.
Required Skills
- Responsible for planning, coordinating and managing the activities of CMC development projects. Works closely with all disciplines within CMC development, including cell line development, cell culture, purification, formulation, drug product, device and analytical development.
- Plan, track and facilitate project startup, tech transfer, Tox material production, cGMP clinical material manufacturing and regulatory filing preparation at CMO sites.
- Manage clinical supply, including demand assessment, inventory tracking, labeling/packaging and distribution activities
- Perform budget and timeline assessments, scenario planning, sensitivity analysis, and the set up and tracking of contracts, accounts payable and accruals
- Serve as project manager on cross functional project teams; communicate and collaborate with members from CMC, QA, Regulatory Affairs, Clinical Development within NGM and with CMOs and CROs to achieve project goals and timelines
- Partner with CMC Team Leader to ensure timely, efficient and effective meetings and adequate progress on team activities to support project goals. Proactively identify and communicate issues, risks and mitigation plans to broader team and management. Conduct and communicate lessons learned to improve on CMC processes
- Provide meeting facilitation and documentation (agendas, documenting minutes, decisions, and action items)
- Organize project information using best practices and tools. Document decisions and lessons learned. Champion knowledge management culture within the CMC group
Required Experience
- Ph.D., M.Sc. or B.Sc degree in Biotechnology or other relevant life science discipline with at least 12 years’ relevant industry experience, with at least 5 years’ experience in a project management role. Level of position may be adjusted based on level of competency and years of experience.
- Experience participating in and leading cross functional teams such as CMC teams
- Experience interfacing with internal operations groups and/or contract manufacturing organizations
- Demonstrated ability to apply and establish best practices of project management
- Knowledge and broad understanding of the CMC approaches, including cGMP operations requirements and relevant regulatory guidelines
- Excellent written and oral communication skills
- Ability to work in a fast-paced environment, to multitask and manage multiple projects
- Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement
NGM offers a creative, collaborative, highly challenging scientific environment, along with a strong compensation package that includes salary, stock options, 401(k) and a comprehensive benefits package.
Interested applicants should apply through the NGM Biopharmaceuticals website: http://www.ngmbio.com/careers/#SilkroadFrame