Carmine Therapeutics is an Esco Ventures X company pioneering a powerful new class of drugs based on engineered red blood cells extracellular vesicles (RBCEVs), founded by Esco Ventures and Professors Harvey Lodish, Minh Le and Jiahai Shi. Carmine’s proprietary Red Cell EV Gene Therapy (REGENT™) platform is positioned to address some of the technological unmet needs related to the delivery of next generation therapeutic modalities such as nucleic acids. Carmine was awarded the 2019 Bristol-Myers Squibb’s Golden Ticket to LabCentral (Cambridge, MA) and has established a research collaboration with Takeda Pharmaceuticals in a deal worth over $900M USD. The company is well-capitalized to develop next generation non-viral gene therapies that would overcome most of the limitations of AAV-based gene therapy. Carmine is based both in Cambridge, MA as well as Singapore.
Carmine’s Cambridge location is looking for an engaged and innovative Senior Director to create and lead the Manufacturing function at Carmine. Reporting to the Head of CMC, this position will establish an internal GMP facility, operations, and external relationships with CMOs to accelerate and scale clinical development of Carmine’s non-viral RBCEV therapeutics. You will work closely with your CMC colleagues to build a group that can implement scalable processes for loaded and unloaded RBCEV purification across multiple development candidates and generate GMP material either internally or externally as driven by corporate priorities.
- Assume overall responsibility for the technical and operational management of GMP manufacturing operations for drug substance and drug product materials supporting clinical studies.
- Build and lead a team, and be responsible for their continued high performance across the Manufacturing organization.
- Partner with Research, CMC, and Clinical leads to develop product strategies.
- Manage the Manufacturing budget, including forecasting/tracking facility and Manufacturing costs.
- Play a key role in facility design, capital projects, commissioning, validation, and future expansion strategy.
- CMO Identification and selection for cGMP manufacturing and clinical trial materials supply.
- Manage drug substance and drug product CMOs for manufacturing operations, technology transfers, investigations, and batch documentation reviews. Responsible for continuous improvement and operational excellence at CMOs.
- Work closely with QA/QC to ensure quality in manufactured materials and manufacturing processes.
- Execute production and resource schedule against the operational plan.
- Complete the final review of completed manufacturing documentation per compliance standards and established timelines.
- Oversee technology transfer of products and processes to the GMP facility.
- Develop policies and strategies for GMP manufacturing operations and expansion.
- Investigate and resolve problems, identifying the root cause, and proposing process improvements through clear communication to the Leadership Team.
- Author regulatory and technical documents for regulatory submissions in support of manufacturing and serve as subject matter expert in regulatory interactions.
- Participate in multi-functional project teams.
- Take corrective action to bring about required changes using change control procedures.
- Maintain a high level of safety, compliance, and efficiency to drive the organization to world-class manufacturing standards.
- Support the continued creation and expansion of the company’s intellectual property.
- Perform other related duties incidental to the work described herein.
Experience & Qualifications
- A minimum of a B.S. in biological sciences or a related scientific field with an advanced degree (M.S., Ph.D. or M.B.A.) preferred, and over ten years of relevant industry experience covering both drug substance and drug product operations
- Complete understanding of tech transfer, cGMP, and global regulatory requirements
- Demonstrated experience supporting technology transfers and cGMP manufacturing operations at third-party manufacturers
- Experience authoring and reviewing regulatory filings
- Excellent oral, written, and presentation communication skills, with proven efficacy at summarizing and presenting decision points and key considerations. Present regular updates to the Leadership Team
- Proven ability to attract top talent and to build the manufacturing team with an inspiring vision for the organization
- Strong leadership skills, including a demonstrated ability to lead a cross-functional team, and to influence at all levels of an organization
- An entrepreneurial approach to develop new, innovative ideas that will drive growth within the Manufacturing organization
- The ability to effectively plan and implement stage-appropriate change management and set realistic goals to ensure timely and successful completion
- Strong analytical, problem-solving, and critical thinking skills, including combining attention to detail with a big picture perspective
- Develop effective and efficient working relationships with both internal and external partners
- Available to travel if/when needed
- Comfortable with the rapid changes inherent in a startup environment. Experience navigating both success and failure of programs with gravitas
- Knowledge of gene therapy/nucleic acid delivery/extracellular vesicles is an advantage
- Team-oriented, motivated, highly-organized, detail-oriented, diplomatic, and calm under pressure, with the ability to thrive in an entrepreneurial and multidisciplinary environment