If you want to propel your career in biologics with a proven team, the Principal Scientist – Analytical Development position at Hemab offers a compelling opportunity. The role requires hands-on industry experience in analytical chemistry or a related field, preferably at the Ph.D. or master’s level, with a minimum of seven years collaborating with CDMOs. This is a full-time position with travel expected around 15 days yearly, with significant cross-functional team interaction and high autonomy.

Key Responsibilities and Daily Life

The Principal Scientist will be responsible for leading analytical development initiatives with an emphasis on both early and late-stage biologics. Tasks include managing method development, validation, and optimization for complex products and overseeing the transfer of analytical methods to manufacturing partners.

Day-to-day duties involve working closely with R&D, quality, manufacturing, and regulatory colleagues to ensure all analytical efforts are aligned to drive the company’s late-stage and commercial aims. Preparation of regulatory documents and direct input to CMC strategies is a core aspect of this job.

The position also involves leading process and product characterization, establishing specifications, and ensuring rigorous compliance with pharmaceutical and regulatory demands. Working in close partnership with CROs and CDMOs forms a key portion of each week.

Additionally, the Principal Scientist will spearhead continuous improvement and provide guidance and data-driven recommendations for internal and external teams. Functioning as the analytical point of contact during regulatory interactions is also within the role’s scope.

Throughout all activities, driving efficiency and sharing best practices will be expected, with flexibility to adapt as project demands shift and new programs launch.

Hauptvorteile

One of the most significant benefits is the opportunity to own high-impact scientific strategies that directly influence late-stage development and commercialization of biologics. The work environment values teamwork and innovation, allowing for meaningful professional growth and a chance to lead industry best practices.

You will also work with a highly skilled, collaborative team devoted to advancing life-changing therapies. Your technical insight is valued and plays a decisive role in regulatory submissions and company success.

Mögliche Nachteile

The complexity and breadth of cross-functional collaboration may be a challenge if you prefer a highly structured or narrowly focused role. Juggling multiple external partners and evolving project priorities could require enhanced organizational skills and adaptability.

The stakes are high given the late-stage focus, and precision is crucial, so expect a fast pace and robust expectations in technical writing, project management, and evolving regulatory standards.

Urteil

Overall, the Principal Scientist – Analytical Development role at Hemab offers exceptional room for scientific impact, leadership, and meaningful participation in biologics innovation. If you are laser-focused on technical growth and look forward to driving major initiatives in biologics, this opportunity presents a strong step forward for your career.