Director, Clinical Manufacturing Operations

Director, Clinical Manufacturing Operations
Department: CMC - Manufacturing

Location: Cambridge, MA

D irector, Clinical Manufacturing Operations

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.  Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.  The company also has a robust novel product pipeline covering multiple indications, for which this role will provide critical direct support of supply for clinical development.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Position Summary

At Seres, we're leading the microbiome revolution and our most revolutionary asset is our team. Their courage and deep commitment are what drives us on our mission to transform the lives of patients worldwide with revolutionary microbiome therapeutics

Reporting to the Executive Director, MSAT & Clinical Manufacturing, you will have an opportunity to exercise complete ownership over the day to day and strategic manufacturing operations of a unique multi-process clinical manufacturing facility for microbiome therapeutics. You'll wear many hats as you build on the foundation for operations at our clinical manufacturing site leading a fully integrated operations organization. This will include developing, coaching and leading a team of manufacturing managers and associates; enhancing current training programs; and responsibility for site production planning, warehouse & logistics, and maintenance & reliability teams. This hands-on role will allow you to build your ideal manufacturing operation, protocols, processes and business processes as you manage the overall production and capacity and implement/oversee manufacturing processes and methods. You'll form close partnerships with Quality Assurance and Quality Control to ensure strict compliance with appropriate cGMPs, with our Bioprocess Development and Supply Chain groups, and other project/product teams. This is a high impact role at Seres as you will be managing the clinical manufacturing processes for all of the company's microbiome therapeutics. This is an excellent opportunity to practice developing value-stream maps and implementing lean manufacturing principles and process improvements for decreased cycle and lead times and product cost.

What You'll Do

• Responsible for a robust internal clinical manufacturing operation including oversight of supporting functions on site: production planning, warehouse & logistics, and maintenance & reliability
• Deliver clinical supplies to support a robust product pipeline
• Nurture and grow a continuous improvement mind-set to ensure best-practice and lean manufacturing concepts to meet quality standards and to exceed internal/external expectations
• Drive a culture of continuous improvement; formulate and manage corrective actions to reduce error, increase reliability and work smarter
• Build and coach a team of managers overseeing clinical manufacturing operations, warehouse and logistics and maintenance and reliability
• Oversee team adherence to Good Manufacturing Practices, standard operating procedures, OSHA, safety and other requirements
• Attend monthly management review and drive team adherence to compliance metrics
• Work closely with Manufacturing Sciences and Technology to establish new processes

What You'll Bring

• Bachelor's level engineering or related degree, with at least 10 years' of experience building and managing a cGMP manufacturing team in the biopharmaceutical industry, or comparable relevant industry experience
• Deep knowledge of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's) with a solid understanding of process, systems and equipment to troubleshoot problems and provide solutions
• Self-motivated with a strong sense of ownership in areas of responsibility, possess excellent interpersonal, verbal and written communication skills,
• Outstanding collaboration skills and a positive outlook to drive team effectiveness and maintain the Seres culture
• Vision for an efficient, highly effective clinical manufacturing operation and a builder mentality to achieve that vision
• Proven track record of delivery on critical objectives for patient benefit and business impact
• You must also be able to work off-shift hours at times

You May Also Bring

• Advanced degree in engineering or related degree
• Experience in other areas, such as quality, manufacturing sciences and technology
• Experience with regulatory inspections, particularly CBER, Office of Vaccines
• Certification or training in Operational Excellence, Lean, or Six Sigma

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.