MSAT Drug Product Lead

Ready to shape how cutting-edge biologics are made?At Windward Bio, we’re focusing on immunology—advancing long-acting biologics that aim to improve outcomes for millions living with severe immune-driven diseases.The OpportunityWe’re seeking an experienced Manufacturing Science & Technology (MSAT) Drug Product Lead to shape how Windward Bio’s biologics are developed, filled, and delivered.This role reports to the Chief Technical Officer and can be based at the company Headquarter in Basel, Switzerland or remotely in the United States across the Eastern & Central Time zones.You’ll be the driving force behind our Drug Product (DP) strategy—leading process ownership from early development through commercialization, ensuring manufacturability, and managing seamless collaboration with our global CDMOs. Acting as the “virtual plant manager,” you’ll guide all DP activities, from vial and syringe filling to device integration and packaging, ensuring flawless execution and regulatory excellence.This is a hands-on, cross-functional role that combines technical leadership, innovation, and operational ownership, empowering you to build processes that will bring Windward Bio’s breakthrough immunology therapies to patients worldwide.If you’re passionate about translating science into scalable therapies, and want to shape how advanced biologics reach patients worldwide — we’d love to meet you!About the job:As part of Windward Bio’s Technical Operations team, the Manufacturing Science & Technology Drug Product Lead (MSAT DP Lead) is responsible for technical and scientific leadership and support to the Drug Product part of all Windward Bio products. This includes filling of Drug Substance into primary containers (vials and pre-filled syringes) as well as any devices (e.g. autoinjectors) and packaging used in the Final Drug Product (FDP) presentation. The DP Lead will also be responsible for operational management of the Contract Manufacturing Organizations (CMO’s) involved in producing DP for Windward Bio. The DP Lead works closely with colleagues from Windward Bio R&D to ensure a high degree of DP manufacturability of the products being developed and will oversee DP technical development and manufacturing at CMO’s. The DP Lead is responsible for leading DP Tech Transfers and for DP ‘process ownership’, which includes technical and scientific support to manufacturing operations, leading process optimization work and providing expertise for process analytics as well as for regulatory filings, from IND to BLA and commercialization. In addition, the role is responsible for building relationships with the technical teams at Partners and CMOs and ensuring excellence in process and product development while maintaining compliance with regulatory guidance.The DP Lead should enjoy working in a small, entrepreneurial biotech environment, embracing the challenge of broad responsibilities and opportunities within a fast-paced, matrix-focused culture. A “hands-on” operational approach and ability to deliver on company goals by efficiently using internal and external resources are at the core of this role.Major Responsibilities:Lead all Drug Product (DP) CMC activities from early development through commercialization, ensuring technical excellence, quality, and alignment across internal and external stakeholders.Drive technology transfers and oversee filling operations (vials, pre-filled syringes, devices) at global CDMOs, acting as Windward Bio’s “virtual plant manager.”Ensure robust analytical methods, validation strategies, and phase-appropriate specifications for DP processes, resolving technical issues proactively.Provide regulatory CMC input and author/review submission content; represent MSAT in meetings with health authorities.Foster strong cross-functional collaboration with R&D, Quality, Regulatory, and Technical Operations, embedding a culture of compliance and continuous improvement.Identify and mitigate CMC risks, ensuring adherence to GMP, GLP, and HSE standards while maintaining operational agility and business-driven prioritization.What you bring to the role:Advanced degree (Ph.D. preferred) in Chemical Engineering, Biochemistry, Bioengineering, or related field.8+ years of industry experience in biologics drug product development or manufacturing, including process characterization, validation, and scale-up.Proven expertise with vial and pre-filled syringe formats; autoinjector or combination-product experience a plus.Strong command of GMP regulations, ICH CMC guidance, and hands-on participation in regulatory submissions and inspections.Experience leading tech transfers and CDMO relationships within a lean, fast-moving biotech or matrixed environment.Analytical thinker & decisive problem-solver with excellent collaboration, communication & adaptability skills.Fluent in English; thrives in a hands-on, entrepreneurial setting that values quality, science, and execution.About Windward BioWindward Bio is a clinical-stage biotech company, headquartered in Basel, Switzerland, committed to improving outcomes for people living with advanced immunological diseases. The company was founded in early 2025 and is led by a highly experienced team of biopharmaceutical leaders with extensive discovery, development, and comer-cialization expertise. At Windward Bio, we are advancing a potential best-in-class long-acting TSLP monoclonal antibody (WIN378) into phase 2 clinical trials while building a pipeline of novel, long-acting bispecific molecules targeting immunological diseases.The company is investigating WIN378 in severe asthma and additional clinical trials are planned in chronic obstructive pulmonary disease (COPD), aiming to address unmet needs in approximately 5 million advanced, uncontrolled patients in the US, Europe, and Japan.Equal Opportunity StatementWindward Bio is committed to improving outcomes for people living with advanced immunological diseases and embraces diversity and inclusivity in its workforce.