About the RoleWe are seeking an experienced
Staff Scientist to lead New Product Introduction (NPI) projects that bridge our R&D and manufacturing teams. In this role you will set the technical direction and own the execution of projects that take new reagents, proteins, antibodies, and assays from late-stage development into robust, scalable, commercial production.
As the scientific and project lead for NPI programs, you will define project scope, plans, and timelines; coordinate cross-functional teams across R&D, Reagent Manufacturing, Quality, and Supply Chain; and make data-driven decisions on scale-up, process validation, and technology transfer strategy. You will design the experimental strategy behind each transfer, establish specifications and release criteria, and mentor scientists and associates on the team. Our ideal candidate combines deep expertise in antibody structure and function, antibody conjugation, and protein expression and purification with a proven record of leading complex product transfers to completion.
This is an individual contributor position at the Staff Scientist level. The position is located in San Carlos, CA and requires full-time onsite presence.
Responsibilities- Lead NPI projects end to end - define scope, deliverables, milestones, and resource needs, and drive cross-functional teams to on-time, on-budget transfer of new reagents, proteins, antibodies, and assays from R&D to commercial production.
- Serve as the technical lead and primary point of contact for assigned products across R&D, Reagent Manufacturing, Quality, Supply Chain, and Program Management; track progress, and communicate status, risks, and mitigation plans to stakeholders and leadership.
- Set the technical strategy for scale-up, process characterization, and process validation; design and oversee studies that improve yield, stability, and robustness of complex formulations and processes.
- Make and defend data-driven decisions at key project gates (e.g., design transfer, pilot readiness, validation, launch), escalating trade-offs between schedule, cost, and quality when needed.
- Partner with R&D to establish QC release criteria, product specifications, guard-band and robustness studies for manufactured reagents; lead specification-setting discussions across teams.
- Lead root-cause investigations of complex production and transfer issues during pilot and production phases; drive corrective and preventive actions (CAPA) to closure.
- Own technical documentation for transferred products, including SOPs, batch records, BOMs, technical reports, and transfer packages, ensuring compliance with quality standards; review documents authored by others.
- Develop and improve NPI processes, templates, and best practices (e.g., stage-gate checklists, transfer plans, risk assessments) that raise the standard for future product transfers.
- Mentor and provide technical guidance to scientists and research/manufacturing associates; delegate and review work on project teams and contribute to hiring and onboarding.
- Remain hands-on in the lab and production environment as needed, including reagent formulation, conjugation, and analytical sample preparation, particularly for new or high-risk processes.
- Support supplier and contract manufacturer selection and technology transfer, including vendor qualification, costing analysis, and supply chain set-up for new products.
Requirements- PhD in chemistry, biochemistry, molecular biology or a related field with 10+ years of relevant industry experience, or a MS with 15+ years of relevant industry experience.
- Proven track record leading cross-functional projects through new product introduction, scale-up, process validation, and technology transfer into manufacturing, ideally for life science reagents, antibodies, or diagnostic consumables.
- Deep knowledge of protein biochemistry, protein purification, reagent formulation, or analytical chemistry (HPLC, MS, FPLC); expertise in antibody conjugation and protein expression and purification.
- Demonstrated project leadership: building project plans, managing timelines, risks, and resources, and holding cross-functional team members accountable without direct authority.
- Experience mentoring and guiding scientists and associates, and delegating and reviewing their work.
- Experience in BOM setup using Arena/Agile software, costing analysis, supply chain set-up, and vendor management.
- Hands-on experience working in controlled development or manufacturing environments (ISO 9001 & ISO 13485), including design control, process validation, and CAPA.
- Excellent communication and influencing skills, with the ability to present complex technical data and recommendations to cross-functional teams and leadership.
- Proficiency in Excel and statistical tools (e.g., JMP, Minitab, or R); experience with project tracking tools (Smartsheet, Microsoft Project, or similar).
- Willingness to work hands-on in the lab and production environment.
