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, Drug Substance Development, CMC
The Director, Drug Substance Development, CMC, is a major contributor to the successful execution of CMC activities to enable a pipeline of project across various modalities, specifically peptides and siRNAs, and plays a key role building the CMC organization and strategy. The role includes managerial responsibility of the Drug Substance Development team to be built. Project management skills and understanding of other CMC activities (Analytical Development and Drug Product and Devices), as well as Quality and Regulatory, are key to build and maintain strong relationships with project core teams internally and CDMOs externally.
ESSENTIAL DUTIES AND RESPONSIBILITIES TO PERFORM THIS JOB SUCCESSFULLY INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING:
- Working with cross-functional R&D partners, drive, develop and execute, with the Drug Substance Development team, the Drug Substance part of the CMC and Manufacturing strategy of an early stage, big concept start-up with direct responsibility over multiple CMC projects for various modalities, including longer term options for moving away from a CMO based process development and manufacturing approach.
- Ensure delivery of robust, scalable and cost-effective drug substance manufacturing routes that meet or exceed the target product/clinical profile. Contribute to define DS process control strategy and perform risk assessment following QbD principle.
- Lead, build and manage drug substance cGMP clinical and commercial manufacturing for various modalities including peptides and siRNAs, including process development, technology transfer, regulatory, quality and life cycle management aspects, and associated logistical and operational infrastructure, mindful of evolving global regulatory frameworks. Ensure timely completion of all functional deliverables including reports and applicable quality and regulatory documents. Has direct responsibility to provide technical expertise for peptides and, ideally, siRNAs.
- Contribute to identify, select and manage Contract Manufacturing Organizations (CMOs) for drug substance process development and optimization, cGMP manufacture and supply of DS in collaboration with the other CMC representatives to ensure continuum with DP and Analytical Development, in support of future, ongoing clinical and commercial supply programs. Lead, manage, supervise and coordinate the work of Drug Substance CMOs, material suppliers, consultants, vendors and collaborators as applicable to meet Drug Substance manufacturing development goals. Can serve as People-In Plant for critical steps during manufacturing campaigns.
- Lead the Drug Substance CMC aspects of all regulatory section submissions and if needed represent the company as the Drug Substance CMC expert in interactions with global regulatory authorities.
- Responsibility, for all Drug Substance CMC activities, in collaboration with Quality, for overall compliance with global manufacturing regulations ensuring that all CROs/CMOs use systems and processes in compliance with all relevant standards.
- Represent CMC in one or more project teams and actively contribute to define the CMC development plans with her/his CMC colleagues from Drug Product and Analytical Development, in alignment with the other functions involved in the projects.
- Ensure maintenance of state-of-the-art knowledge of peptides and, ideally, siRNAs drug substance development and manufacturing providing guidance and advice to the executive team shaping product development. Contribute to regulatory intelligence for the manufacturing of these modalities.
- Maintain and enhance a network of consultants, vendors, and suppliers to supplement internal capabilities, to adequately support active and future development programs and commercial products.
- Provide oversight and technical guidance for the Drug Substance CMC part in support of due diligence for potential in-licensing activities, external collaborations, and acquisitions.
- Contribute to build a world class CMC team for all DS manufacturing related activities.
- Formulate, monitor and control budgets for the Drug Substance part of the CMC and Manufacturing activities.
EDUCATION AND/OR EXPERIENCE
- Bachelor’s degree in a relevant subject (e.g. chemistry, chemical engineering, biochemistry, biotechnology) or related scientific discipline with PhD or Masters in science preferred.
- Minimum 15-20 years of extensive industrial experience of peptides (and siRNAs preferably) phase-appropriate development, especially early-stage, and their characterization, and has been an integral part, in a leadership capacity for a minimum of 3-5 years of steering products through to market, preferably with a demonstrated innovative approach.
- Possess expert knowledge and proven “hands-on” track-record in process development, GMP manufacturing, technical transfer, scale-up and commercial stage manufacturing of peptides (and siRNAs preferably). Capable to leverage and foster her/his existing network of experts’ relationships.
- Experience with complex therapeutic biologics (antibodies modalities notably) is a plus.
- Prior working experience in outsourcing and managing CMOs.
- Previous experience serving as CMC drug substance lead for multiple programs.
- Demonstrated knowledge of relevant FDA and EMEA regulations and best industry practices related to CMC peptides, and if possible, siRNAs and/or biologics, Drug Substance matters, and related experience (e.g. ICH/FDA/EMA/GMP) including audits/inspections, preparation, writing and submission of IND/CTA mainly and preferably also BLA/NDA/MAAs, and interactions with regulatory bodies.
- Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs, with a demonstrated ability to identify, execute and deliver value-creating solutions to the most complex of CMC issues.
- Ability to be innovative within constraints of cGMP environment with a drive to reduce cost-of-goods through innovative approaches.
- 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.
- Must be able to travel (EU/US/international) up to 20%.
