Senior Director/Vice President, CMC
2 months ago
Repertoire Immune Medicines is a biotechnology company working to unlock and direct the remarkable power of the human immune system to treat cancer, autoimmune disease and infectious disease. The company was founded on the belief that understanding the repertoire of T cell receptor (TCR)-antigen immune synapses that maintain health and drive disease represents one of the greatest opportunities for innovation in medical science. Repertoire scientists created and developed the DECODETM platform, which allows in-depth characterization of TCR-antigen pairs, and the ability to deploy this information in the form of novel targeted immune medicines to fundamentally reprogram the immune system to kill tumors or induce immune homeostasis.
From its sites in Cambridge, Massachusetts and Zurich, Switzerland, Repertoire’s team is advancing a pipeline of DECODE-enabled immune medicines, such as TCR bispecifics and mRNA cancer vaccines for treatment of solid tumors and mRNA tolerizing vaccines for treatment of autoimmune diseases.
Repertoire was founded by Flagship Pioneering and is supported by a strong investor base. In addition, the company recently entered into a strategic partnership with Bristol Myers Squibb to develop tolerizing vaccines for up to three autoimmune diseases.
Role Overview
We are seeking a senior CMC leader with experience to advance our TCR bispecific therapies from lead candidate to clinical development, including internal upstream and downstream development of robust manufacturing processes as well as tech transfer and oversight of cGMP manufacturing at external contract development and manufacturing organizations (CDMOs). This highly motivated leader will have proven management experience of process development teams and has led and built systems and processes in an early-stage research company to enable advancement of a pipeline of protein biologics into clinical development.
This leader will interface with multiple internal functions, such as Repertoire preclinical, regulatory, and clinical functions, and will provide leadership and guidance across the organization to drive technology transfers to CDMOs. She/he/they has managed challenges through various company growth stages and is inspired to influence organizational culture and teams to support achievement of critical corporate goals.
Key Responsibilities
- Build and lead effective CMC Teams to develop and optimize upstream and downstream processes to generate lead and Development Candidate protein biologics.
- Provide CMC expertise and guidance to inform Development Candidate nomination.
- Identify CDMOs, develop contracts in conjunction with Executive Leadership and Finance.
- Transfer manufacturing processes to CDMOs and manage CDMO activities from candidate nomination through process development, analytical development, and early phase clinical manufacturing to ensure on-time delivery of material for IND enabling and clinical studies.
- Transfer analytical methods to external CROs/CDMOs and provide additional training, troubleshooting, or technical support, as necessary.
- Manage analytical and stability programs at CROs.
- Author and review technical documents and reports for inclusion in CMC sections of regulatory filings.
- Develop goals, operating plans, production milestones, and short and long-term objectives for all CDMO/CRO contracts.
- Proactively identify opportunities to accelerate manufacturing to enable clinical start in a compressed timeline.
Qualifications/Experience
- PhD degree in Biochemistry, Biology, Bioengineering, Immunology, or a similar field.
- 15 plus years’ experience in pharma/biotech industry with significant management experience in upstream/downstream process development and manufacturing of protein therapeutics.
- Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up .
- Experience in research strategy development and operational management of research outcomes through cross-functional and outsourced teams, as well as budget planning and management.
- Well-developed understanding of all aspects of drug development with includes direct experience in working with research and clinical organizations.
- Creates breakthrough approaches within and across functions, if appropriate, to meet stretch goals impacting company direction.
- Desirable to have experience with bispecific protein products.
- Technical report writing for inclusion in regulatory submissions.
- Proven and extensive leadership and people management skills with the ability to work cross-functionally and communicate effectively across functional areas.
- Ability to drive strategic discussions with senior level management and external partners.
- Domestic and International travel required to support management of CDMOs.
Repertoire is proud to be an Equal Opportunity Employer.
Recruitment & Staffing Agencies: Repertoire Immune Medicines (“Repertoire”) does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Repertoire or its employees is strictly prohibited unless contacted directly by Repertoire’s internal Human Resources team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Repertoire, and Repertoire will not owe any referral or other fees with respect thereto.
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