Senior Scientist, Drug Formulation and Process Development

• 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

• Master’s degree or equivalent in e.g. pharmaceutical sciences, chemical engineering, biotechnology or biology
• Minimum 5 years of industrial experience with complex subcutaneous therapeutics
• 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

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