Career Opportunities with Seres Therapeutics, Inc.

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Careers At Seres Therapeutics, Inc.

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Engineer, CMC Projects

Department: Manufacturing
Location: Cambridge, MA

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases.  We are pioneers and explorers, charting a new course. 

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

As an Engineer, CMC Projects you will work with the CMC senior staff to plan and manage the execution of high quality, integrated, cross-functional projects.  You will be part of a dynamic team focused on transferring upstream, downstream, and drug product processes for the manufacture of microbiome therapeutics from the laboratory into cGMP clinical and commercial manufacturing.  In this role you will have a range of responsibilities from planning and leading projects to rolling up your sleeves and helping with the successful execution of those projects.

What You’ll Do

  • Develop tools and mechanisms for monitoring project progress, problem solving within project teams, and driving successful execution of projects
  • Identify and analyze project risks and guide project teams to develop appropriate mitigation strategies
  • Identify and implement technologies and strategies to enable scale up of upstream, downstream, and drug product manufacturing processes
  • Author, execute, and approve clinical manufacturing, tech transfer, process validation, and equipment verification protocols and reports
  • Develop and execute knowledge management strategies for data generated during process and product development projects
  • Maintain working knowledge of clinical supply and advise project teams on manufacturing needs
  • Support annual updates to regulatory filings and new filings
  • Develop and implement stakeholder management and communication plans
  • Manage external CMO partner change orders by identifying need, identifying sources of information, and obtaining internal and external approvals.
  • Ability to balance the need for long range planning while rolling up your sleeves and helping to execute on short-term deliverables. 

What You’ll Bring

  • Bachelor's degree in Science, Engineering or a related field with 5+ years' relevant industry experience in biopharma project management / process development / manufacturing; or Master's Degree in Science, Engineering or a related field with 3+ years' relevant industry experience
  • Strong ability to embrace ambiguity and complexity and demonstrate problem-solving leadership; ability to translate complex concepts into actionable, measurable tasks and drive those tasks to completion on time and on budget
  •  Ability to create effective relationships, motivate others, influence without authority, and collaborate internally and externally at all organization levels

You May Also Bring

  • Strong technical acumen in biological manufacturing process development, tech transfer, cGMP manufacturing
  • Prior CMO project management experience strongly preferred
  • Project Management Professional (PMP) Certification
  • Project management experience with cross functional team management experience; CMC project management background and understanding of clinical development process preferred
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development is a plus

Compensation and level are commensurate with experience.

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome.  Founded by Flagship VentureLabs, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome.  Current candidates span infectious, metabolic, and inflammatory diseases.  For more information, please visit http://serestherapeutics.com/

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