We are seeking an experienced, creative Director of Drug Substance Development within CMC to help build and deliver the company’s pipeline and transform patient lives through the creation of a world class development team. The Director of Drug Substance Development will be part of the company's CMC and Manufacturing team and contribute to the company's vision for developing next generation prophylactic products for people with high unmet need bleeding and thrombosis disorders. S(he) will report to the SVP, CMC and Manufacturing and will partner especially with leaders in Research, CMC, Regulatory and Program management.
The Director of Drug Substance Development will be a key CMC position that will provide biologic Drug Substance expertise, oversee and be accountable for all drug substance activities, from cell line and drug substance developments to GMP manufacturing for Hemab’s various assets. The candidate will provide strong technical leadership and oversight to the development of robust drug substance development plans and processes and plays a critical role in our interactions with Contract Manufacturing Organizations. Furthermore, this role leads broadly in a cross-functional and multicultural environment and leverages an extensive experience to represent CMC Drug Substance in discussions with external and internal stakeholders.
The candidate must be an entrepreneurial, highly motivated and purpose driven leader who is able to flexibly and efficiently lead and interact with multi-disciplinary teams within our focus area of bleeding and thrombosis. The successful candidate will have a track record of accomplishments in biologics drug substance development and manufacturing, especially antibodies modalities. S(he) must exhibit excellent leadership, project management, and strong collaboration and communication skills. S(he) should be ready to champion new ideas in a very dynamic, international, and innovative environment.
- Working with cross-functional R&D partners, drive, develop and execute the Drug Substance part of the CMC and Manufacturing strategy of an early stage, big concept biotech with direct responsibility over multiple CMC projects, including longer term options for moving away from a CMO based manufacturing approach.
- Deliver 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 from cell processing, including technical 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.
- Contribute to identify, select and manage Contract Manufacturing Organizations (CMOs) for drug substance process optimization, cGMP manufacture and supply of DS in collaboration with the other CMC representatives to ensure continuum with DP and Bioanalytics, 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. 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 for overall compliance with global manufacturing regulations ensuring that all CROs/CMOs use systems and processes in compliance with all relevant regulatory 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 Bioanalytics, in alignment with the other functions involved in the projects.
- Maintain state-of-the-art knowledge of biologics drug substance development and manufacturing providing guidance and advice to the executive team shaping product development. Contribute to regulatory intelligence for the manufacturing of biologics products.
- 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.
- Bachelor’s degree in a relevant subject (e.g. biotechnology, chemical engineering, biochemistry) or related scientific discipline with PhD or Masters in science preferred.
- Minimum 10-15 years of extensive industrial experience of complex therapeutic biologics (antibodies modalities notably) phase-appropriate development, especially early-stage, and protein characterization (HPLC, cIEF, capillary electrophoresis, LC/MS, peptide mapping, spectrophotometry, light scattering, etc.) 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, technical transfer, scale-up and commercial stage manufacturing of complex biologics for all steps of Drug Substance development, including cell line. Capable to leverage and foster her/his existing network of experts’ relationships.
- Prior working experience in outsourcing and managing CMOs is highly preferred.
- Previous experience serving as CMC drug substance lead for multiple large molecule programs.
- Demonstrated knowledge of relevant FDA and EMEA regulations and best industry practices related to CMC 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.
Hemab is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
As a healthcare company Hemab has an important responsibility to protect individual and public health. All roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.