Senior Director, Manufacturing

Department: Manufacturing
Location: Cambridge, MA

Seres Therapeutics is well-positioned to become the first company to bring a microbiome drug to patients through our proprietary discovery and design platform.  We identify key alterations in the microbiome that are associated with specific diseases, and are designing live bacterial ecologies as therapeutics.  We are conducting multiple clinical trials including a recently approved Phase II study with the potential to be a pivotal trial.  Seres is a dynamic and well-financed biotechnology company located in Cambridge, MA.

What’s in it for you?

You will have an opportunity to lead our state-of-the-art GMP manufacturing facility and our pilot plant operation in Cambridge with a current staff of approximately 20 people.  You will also serve as the key relationship manager for our external CMOs.  You will have the opportunity to prepare Seres for future success as you build our manufacturing organization and infrastructure, and develop and implement new manufacturing controls in a novel therapeutic space as we evolve from clinically-focused to commercial-ready state of operations.   There is no playbook for how to manufacture microbiome therapies - You will be a key architect.  You will work closely with Seres’ scientists and engineers, and regulators, to define and implement new standards that will serve as the benchmark for others that follow.

How do you know if you’re the right fit?

You embrace risk and can move fast.  You will have a background in microbiology, biologics, and/or vaccine production and understand complex, live products.  You will have multi-product manufacturing experience, handling competing production schedules, and challenging technical problems; you may have worked at a Contract Manufacturing Organization (CMO), understanding the realities of fast-paced, service-oriented performance.  You will have lived through a transition from clinical to commercial manufacturing, and have a vision for building out a commercial organization.  You will understand that live biologicals require a new approach altogether and you will be comfortable applying your past experiences with a new twist.  You will also be excited to use your experiences, systems knowledge and innovative mindset to develop overall operational efficiency across the bioprocess development lifecycle from first-in-man to commercial.  You’ll find opportunities to take standard manufacturing equipment and processes and re-engineer them to make them fit-for-purpose - you will gain a deep understanding of the unique characteristics of working with live bacteria as a therapy.  Most importantly, you enjoy leading and growing teams.  You develop key technical experts into future leaders.   You will have a strong managerial and culture-building component that will grow a manufacturing organization and bring it to maturity.

The technical requirements

This role is best suited for a highly strategic senior level professional who has brought therapies from pilot manufacturing to commercial.  Ideally you would have multi-product facility experience and have filed at least one BLA.  You have at least 10 years of industry experience and an in-depth background in manufacturing facilities, systems, operations, technical support and technologies for biologics and relevant industries.  You will report directly to the Chief Technology Officer where you will have direct influence on the strategy and direction of the CMC organization.

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System