Join Hemab as Director, CMC Drug Product Development in Boston, USA, or Copenhagen, Denmark

About Hemab

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

• Master’s degree or equivalent in e.g. pharmaceutical sciences, chemical engineering, biotechnology or biology
• 10+ years of industrial experience of complex subcutaneous therapeutics
• Experience with early and late-stage development and has been an integral part in development and steering of products through to market. Preferably with a demonstrated innovative approach
• Possess expert knowledge and proven “hands-on” track-record in patient-centric liquid and lyophilized formulations, vial, syringe and combination product development, stability and in-use studies, specifications and justification of specification, process development, GMP fill and finish, technical transfer and commercial stage manufacturing of complex products
• Proven ability to work with outsourcing and managing CMOs
• Experience serving as CMC drug product lead for multiple programs including drug delivery and combination products is a plus
• Experience with regulatory and quality documentation according to Good Manufacturing Practice
• Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs, with a proven ability to identify, execute and deliver value-creating solutions
• A motivated self-starter, resilient, capable of hitting the ground running and excelling in a high growth, entrepreneurial business environment. Proven ability to take initiative in a technical, multicultural global working environment, leading by example while having an inclusive, collaborative style
• Travel: up to ~30 days per year

Location: Boston, USA or Copenhagen, Denmark.