Drug Substance

At
Polpharma Biologics Switzerland AG
, we are building something different – a biosimilar company defined by purpose, speed, and people. We own the full value chain, from product selection to global launch, making high-quality biologics more accessible worldwide. We are looking for a
Drug Substance & Cell Line Development Principal
to join our lean, empowered, cross-functional team. If you are passionate about driving innovation with internal teams and external partners—and ready to lead technical strategy and troubleshooting in commercial manufacturing under ambitious timelines—this is your moment to make an impact.

Your responsibilities include, but are not limited to:

• Leading technical transfers to CDMOs, between CDMOs, and between CDMOs and commercialization partners, as required by specific programs, including acting as a Technical Transfer lead and overseeing the budget. Manufacturing sites and development partners may be located outside Europe.
• Developing and leading the strategy for cell line development (CLD) and upstream drug substance (DS) manufacturing that meets biosimilarity objectives.
• Planning timelines, resources, budgets, and risk assessments with mitigation strategies.
• Selecting and integrating new technologies (such as screening, vector design, expression systems, automation) to enhance speed, yield, cost-efficiency, and consistency.
• Supporting and leading technical evaluations of Contract Manufacturing Organizations (CDMOs) in line with program requirements.
• Serving as a Subject Matter Expert (SME) for Drug Substance manufacturing and Cell Line Development.
• Ensuring the creation and proper characterization of cell banks (master, working), including genetic and phenotypic stability assessments.
• Providing development support with manufacturing expertise and offering ongoing support and guidance throughout the molecule's lifecycle. Troubleshooting technical issues with external partners, managing Changes and Deviations.
• Assisting Regulatory Affairs with IND/BLA processes.
• Collaborating closely with Program Management, Quality, Supply Chain, Regulatory Affairs, and their CDMO counterparts.
• Acting as the single point of contact for technical inquiries related to assigned molecules (i.e., serving as the product steward), and supporting inspections by health authorities and partners (e.g., PAI at assigned CMOs).
• Contributing to the development of internal procedures and documentation as needed.

What you bring:

• Over 7+ years of experience in the (bio-)pharmaceutical industry, with direct experience with Biopharmaceutical products.
• Academic background in a relevant discipline (pharmacy, biotechnology, biochemistry, chemistry).
• Extensive experience in Manufacturing Science and Technology (MSAT), Technical Development, Production, and/or other relevant operational areas with good technical understanding of related processes and health authority expectations.
• Extensive experience with the project management/technical transfers, ideally biosimilars.
• Experience with (commercial) production of biologics/biosimilars.
• Experience working with/for contract manufacturing organizations (CMO/CDMO).
• Thorough knowledge of cGMP/regulatory requirements.
• Experience in Drug Product/Finished Pack manufacturing, devices, QC, or method development/analytics is advantageous.
• Ability to work efficiently in a matrix organization with competing priorities.
• Ability to work in a global environment; intercultural competence.
• Ability to work independently, hands-on, start-up mindset.
• Willingness for international business travel to CDMOs.
• Very good command of English. Other languages are a plus.

What we offer:

At Polpharma Biologics Switzerland, we believe in working with care — for patients, partners, and each other. We empower every team member to own their work, unlock their potential, and shape the future of biosimilars with purpose. To support your well-being, growth, and sense of meaning, we offer a comprehensive range of benefits, including:

• Competitive package with base salary, bonus and fringe benefits.
• Attractive pension plan with preferential savings and risk components.
• Hybrid workplace model, with a nice office in Zug/Switzerland and home-office possibility.
• An empowered team that enjoys driving our business forward together, and celebrates shared wins.
• A purposeful industry association where we enlarge the access for patients in need with affordable solutions.