Executive Director of Manufacturing Operations and MSAT

Description

Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.

Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is now well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. The company’s lead program is in Phase 2 clinical development (MAR001), and a second program is progressing towards clinical development acromegaly. Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardioendocrine diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardioendocrine diseases, human genetics, and adipocyte biology.

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

ABOUT THE ROLE

The Executive Director of Manufacturing Operations and MSAT (Manufacturing Science and Technology) is a unique technical leadership opportunity that combines a broad scope of responsibilities : operational oversight of multiple drug substance (DS) and drug product (DP) CDMOs, tech transfers and clinical supply logistics. Given the early stages of forming the Technical Operations organization at Marea in a start-up environment, this role is expected to provide strategic CMC thought partnership as well as hands-on operational execution leadership. This role is expected to develop Marea’s manufacturing strategy across the portfolio with a goal to ensure reliable supply and at the same time ensure on-time and high-quality execution of planned scope of work through our external manufacturing and supply partners. Successful candidate will have a mix of technical / operational experience in both DS and DP disciplines at various stages of biologics development. Reporting to the CTO, this is a key role Technical Operations leadership team as we aggressively advance the first program towards late-stage development and our second program into early-stage clinical development. The candidate will work closely with other members of the technical operations team including technical development, quality and regulatory CMC as well as cross-functionally with research and clinical operations team to support the program goals. On the manufacturing operations part of the role, the candidate will oversee contract and agreement negotiations with the CDMO, operational oversight of the planned work and building a strategic combination of CDMOs / CTLs to enable capital efficient and aggressive CMC development and manufacturing path. AS part of the MSAT responsibilities, candidate will plan and execute tech transfers, process and method improvements (working with technical development) and resolve complex manufacturing issues in a timely manner. As part of the clinical supply chain role, candidate will partner closely with clinical operations to ensure oversight of all the nodes in the supply chain from the point of drug product release to drug product availability at the clinical site, including packaging, labeling, storage and shipping operations. Good understanding of the necessary ICH and USP regulations and experience supporting regulatory submissions at various development stages is desired.

Requirements

• Evaluate and select CDMOs and CTLs for the Marea Biologics portfolio, aiming for a strategic combination to provide necessary technical and operational capabilities to ensure reliable supply and on-time delivery of development work packages
• Responsible for day-to-day operational oversight of CDMOs and CTLs while ensuring that the external deliverables meet the needs of the internal CMC and project teams
• Negotiate service agreements and contracts and manage and ensure the needs of the CMC team are fully met through the contract
• Maintain ongoing relationships with CDMOs and CTLs both on the business as well as operational axis
• Work with the internal technical and quality SMEs in the Tech Ops team to ensure timely resolution of complex manufacturing and quality issues, investigations, CAPAs and regulatory requests
• Plan and execute technology transfers and major product life cycle improvements at the CDMOs, working closely with technical development and quality
• Partner with quality and technical development to enable on-time batch disposition
• Author sections of Module 3 for regulatory submissions such as briefing books, IND, amendments, information requests and in the future BLA. Coordinate inputs from the CDMOs and CTLs in support of such submissions
• Develop strategy and execute plans for clinical supply chain overseeing and coordinating operations across the supply chain nodes from cell banks, DS, DP, packaging / labelling, shipping, storage and final delivery to the clinical sites across multiple jurisdictions.
• Work with quality and regulatory to proactively identify risks in supply chain and develop mitigation and response plans upfront to enable uninterrupted supply for the ongoing clinical trials
• Develop plans, timelines and budgets for external manufacturing and supply chain activities and ensure these are captured as part of the short- and long-term operating plan
• Work with clinical operations to ensure alignment of assumptions for supply chain and clinical trial with an aim to ensure continuity of supply while minimizing waste and balancing risk.

QUALIFICATIONS

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