Manager / Sr Manager, Formulation & Drug Product - Biologics
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 is currently seeking qualified candidates to join our Formulation and Drug Product development team. The Manager or Senior Manager will be a critical contributor to the CMC team, and will manage CMO partners and program development.
- Independently design, execute internally and/or oversee execution by CROs and CMOs of formulation development projects for protein based therapeutic candidates, including monoclonal antibodies, fusion proteins, and recombinant proteins.
- Support process development for drug product fill/finish operations at CMOs
- Define and drive stability studies
- Serve as liaison for drug product GMP production, serve as lead and provide oversight for activities performed at CROs, CMOs.
- Support drug product investigations, develop and execute experiments in the laboratory as needed. This role involves both managerial and hands-on activities.
- Maintain good record keeping of laboratory work in electronic lab notebook. Organize, analyze, and write up data in presentations and reports
- Author and review protocols, technical reports, SOPs, and other technical documents
- Review IND/CTA formulation and drug product related regulatory filing sections
- May serve as a member or the leader of cross functional project teams such as CMC teams
- B.S./M.S./PhD. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Bioengineering, or related field
- Relevant industry experience in development of proteins or protein-based modalities (5-8 years). Position level will be commensurate with education level and previous industrial experience.
- General knowledge of the workstreams in the development of protein therapeutics - formulation, drug substance and drug product development, analytical development stability testing, upstream and downstream processing preferred
- Experience with drug product fill/finish process development and manufacturing; previous experience with CROs, CMOs and tech transfer is a plus.
- Familiarity with protein characterization methods and experienced with corresponding analytical techniques: HPLC/UPLC (Empower, Chemstation), osmometer, MFI, HIAC, DSC, DLS, Viscometry. Hands-on experience with a few of these techniques is expected and ability to provide subject matter level of expertise for some of these techniques is desirable.
- Excellent teamwork and collaboration skills. Adaptability to cross-functional environment with internal and external customers. Ability to develop working relationships with individuals and organizations.
- Must be able to work in a fast paced, multi-project and changing environment with ability to manage multiple competing responsibilities with a high degree of independence and self-motivation.
- Outstanding written and verbal communication skills
- Independent and creative thinker
- Strong organization and time management skills
- Experience interacting with Clinical Operations groups and an understanding of clinical considerations
- Experience with multiple drug product configurations (e.g. liquid vials, pre-filled syringes, lyophilized products, combination products) as well as experience with multiple administration routes (e.g. subcutaneous, intraocular, intravenous) is desirable.
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: https://www.ngmbio.com/open-positions/
Note to Recruitment Agencies: Please do not forward any agency résumés. NGM Bio is not responsible for any fees related to résumés that are unsolicited.