Associate Director, Director - Multi-dose Device Development
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 combination device development position open in our CMC team. The team is responsible for progressing NGM’s cutting edge science derived protein based therapeutics. As a Director of Device Development, the candidate will lead technical activities to develop, manufacture and commercialize drug-device combination products for projects currently in NGMs clinical pipeline and for potential future candidates. The position requires in-depth knowledge of combination product design control workflows. There are regular interactions with multiple CMOs, CROs and consultants. The position also works closely with project management, clinical development, quality and regulatory affairs. Successful candidate shall be an accomplished technical leader with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.
Core Job Responsibilities:
- Responsible for planning and executing development of combination devices for injectable protein drug products. Works closely with other disciplines within CMC development, including drug substance, formulation, drug product and analytical development.
- Propose solutions and make technical decisions to generate devices with suitable and optimal functionality
- Manage all activities associated with generation of design history file. Lead generation of technical content for regulatory filings.
- Collaborate closely with key CMOs, including device manufacturer, drug product fill manufacturer, packaging/labeling vendor, testing CROs
- 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
- Perform cost/budget assessments, scenario planning, sensitivity analysis, set up and execution of contracts
- Organize project information using best practices and tools. Document decisions and lessons learned. Champion knowledge management culture within the CMC group
- Ph.D., M.Sc. or B.Sc degree in Bioengineering or other relevant engineering discipline with at least 12 years’ relevant industry experience. 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 in developing and commercializing drug/device combination products, such as autoinjectors and multi dose pen injectors
- Experience working with fill/finish and device CMO’s to optimize drug delivery system integration
- Experience interfacing with internal operations groups and/or contract manufacturing organizations
- 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 click "Apply"