Opportunities as a Senior Scientist within drug product development

At Hemab you will join a clinical-stage biotech company on an exciting journey to build the ultimate clotting company focusing on high unmet need for patients suffering from neglected bleeding and thrombotic disorders. Based in Copenhagen (DK) and Boston (US) Hemab offers a great working environment, where we believe that a balanced and varied working life can go hand in hand with high-quality drug discovery from idea to market.

As a Senior Scientist within drug product development, you will play a key role in enabling a robust pipeline across various modalities. As we build our teams, this position offers the opportunity to shape the CMC drug product strategy. Further you will contribute to the organization’s evolution as we transition into a commercial-stage biotech company.

The ideal candidate will possess strong scientific as well as project management skills, a comprehensive understanding of related CMC areas, and a desire to contribute to Hemab's growth. We are looking for a candidate who likes to make decisions, enjoys collaborative discussions with colleagues across functions, and is excited about building processes from the ground up, always keeping patient needs and product quality as top priorities. You are experienced and enjoy sharing your knowledge while also learning new skills, closing gaps, and doing it all with good humor.

Responsibilities

• Deliver 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 development, cGMP manufacture and supply of drug and drug-device combination products

• Collaborate with cross-functional R&D partners to develop strategy and execute on activities

• Lead, supervise and coordinate the work of CMOs, material suppliers, consultants and vendors as applicable to meet manufacturing development goals

• Contribute to ensure that CMOs follow relevant regulatory standards

• Support and write regulatory documentation and support interactions with Health Authorities

• Other duties as assigned

Qualifications and Skills

• Master’s degree or equivalent in e.g. pharmaceutical sciences, chemical engineering, biotechnology or biology

• 10+ years of industrial experience with complex subcutaneous therapeutics

Key competencies:

• Experience in early and late-stage development has been an integral part in developing and steering products through to market. Preferably with a demonstrated innovative approach

• Possess expert knowledge 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 of CMOs

• Experience serving as CMC drug product responsible for multiple programs including drug delivery and combination products is a plus

• Experience with regulatory and quality documentation according to cGMP practice

• Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs

• A motivated self-starter who is 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

• You work hard and are not afraid to have a little fun while you do so

Travel: 15-30 days per year

REPORTS TO: Anja R. H. Skands, VP Drug Product and Device Development, CMC

TEAM: CMC and Manufacturing