Director, Downstream Process Development

Marea Therapeutics; South San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Marea Therapeutics in South San Francisco is seeking a Director of Downstream Development to lead downstream process development from clinical to commercial scale, oversee tech transfer between CDMOs, and provide hands-on troubleshooting and data packages to support comparability and regulatory submissions.

Collaborating with drug product and analytical teams, you will develop and implement robust control strategies and contribute to CMC development for two programs in a lean startup setting.

Responsibilities

• Develop downstream process conditions with parameters aligned to the CDMO platform for monoclonal antibody manufacturing
• Identify, evaluate, and qualify unit operations, raw materials, equipment, sampling plans and in-process testing and control strategies
• Design and oversee studies for process optimization and cost-effective manufacturing
• Provide technical oversight of development and manufacturing activities at the CDMO
• Develop process and control strategies for consistent and reproducible drug substance manufacture
• Support deviations, OOS investigations, root cause analysis, and CAPAs as needed
• Manage troubleshooting activities as necessary

Job description

Director, Downstream Process Development

ABOUT THE COMPANY

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

The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year.

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

This is a key role within our Technical Operations team as we aggressively advance our first program towards late-stage development and our second program into early-stage clinical development. This role will report to the VP of Technical Development.

The Director of Downstream Development will play a critical technical role focused on all aspects of downstream process development, scale-up from clinical to commercial scale, tech transfer of the process from one CDMO to another, operational and technical oversight of the CDMO, process troubleshooting and improvement, and generation of suitable technical data packages to support comparability assessment and eventual regulatory submissions. It is expected that the individual will also work closely with the drug product and analytical teams and, eventually, across the entire technical operations and Marea project team to support the overall development of the two programs. This role will also develop and maintain the economic model for the downstream process for each of our programs.

It is expected that we will operate in a very lean environment and leverage the technical resources of the CDMO in addition to consulting and advisory resources to help us achieve our CMC development goals in support of the larger program milestones. We expect this candidate to be hands‑on as needed and adaptable to the evolving needs of a start‑up.

KEY RESPONSIBILITIES

• Develop downstream process conditions with key parameters specified, leveraging the CDMO process platform adapted to our specific monoclonal antibody
• Identify, evaluate, and qualify unit operations, raw materials, equipment, sampling plan and in‑process testing and overall control plans for the downstream process (Seed train, inoculum train, bioreactor and harvest) with thoughtful integration into the overall manufacturing process from seed train to final vial
• Design and oversee studies/activities necessary for process optimization and continuous improvement to assure robust and cost‑effective manufacturing processes
• Provide technical oversight of the development and manufacturing activities at the CDMO
• Develop process and control strategies with an eye towards consistent and reproducible manufacturing processes and final drug substances
• Support manufacturing deviations, OOS, investigations, root cause analysis, and CAPAs, as necessary
• Manage and execute troubleshooting activities, as necessary