Director, Drug Product Development, CMC

At Hemab, you’ll join a clinical-stage biotech company dedicated to becoming the ultimate clotting company. We focus on addressing the high unmet needs of patients with neglected bleeding and thrombotic disorders. With locations in Boston, USA, and Copenhagen, Denmark, we provide a collaborative working environment where a balanced, fulfilling work-life complements our commitment to delivering high-quality therapies from discovery to market. Hemab is driven by a vision to grow into a leading commercial biotech company, and we seek individuals who are passionate about contributing to this transformative journey.

Position : Director, CMC Drug Product Development

We are seeking an experienced leader to play a pivotal role in enabling a robust pipeline across various modalities. This position offers the opportunity to shape the CMC drug product strategy while building the team’s way of working from the ground up. The successful candidate will contribute to the organization’s evolution as we transition into a commercial-stage biotech company.

Responsibilities include driving the strategy, planning, execution, and oversight of drug product and drug-device combination product development, as well as fostering strong collaborations with stakeholders internally and Contract Manufacturing Organizations (CMOs) externally.

The ideal candidate will possess strong project management skills, a comprehensive understanding of related CMC areas (analytical development and drug substance), and a desire to contribute to the growth of Hemab by developing innovative and scalable processes that support our long-term goals.

ESSENTIAL DUTIES AND RESPONSIBILITIES TO PERFORM THIS JOB SUCCESSFULLY INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING :

• Collaborate with cross-functional R&D partners and leadership to develop the strategy and execution of activities within development of drug products and drug-device combination products.
• Deliver robust subcutaneous formulations and drug and combination product manufacturing processes that meet the target product profile.
• Manage drug product cGMP clinical and commercial manufacturing for various modalities e.g peptides, siRNAs and biologics (antibodies notably), including formulation, process development, technology transfer, quality and life cycle management aspects.
• Contribute to the selection and management of CMOs for drug product formulation and process optimization, cGMP manufacture and supply of drug product and drug-device combination products.
• Lead, supervise and coordinate the work of Drug Product CMOs, material suppliers, consultants and vendors as applicable to meet manufacturing development goals.
• Responsible for the activities for overall compliance with global manufacturing regulations ensuring that all CMOs use systems and processes in compliance with relevant regulatory standards.
• Support and write regulatory documentation and support interactions with Health Authorities.
• Represent CMC in project core teams and actively contribute to define the CMC development plans.
• Contribute to build a world-class CMC team within drug product and drug-device combination products.

EDUCATION AND / OR EXPERIENCE

Location : Boston, USA or Copenhagen, Denmark.

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