Seres Therapeutics is a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic® microbiome therapeutics. Seres has promising late clinical stage programs and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria. Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including infectious disease, inflammation and metabolic disease and to build upon its field-leading portfolio of intellectual property and know-how.
Seres Therapeutics is seeking a highly motivated Senior MSAT (Manufacturing, Science, and Technology) Engineer to join our Manufacturing Sciences & Technology team. We are focused on developing and supporting manufacturing processes to enable cGMP manufacturing of Seres Therapeutics’ pipeline products. In the role you will work closely with various groups, including Bioprocess Development, Manufacturing Operations, Facilities & Engineering, Supply Chain, Regulatory, Quality Control, and Quality Assurance.
- Responsible for new product scale-up, process optimization, technology transfer and process validation activities.
- Serve as technical expert for the drug substance and drug product manufacturing processes on internal and external teams.
- Manage timelines, deliverables, and personnel from project ideation through completion.
- Lead and facilitate criticality and risk assessments for manufacturing processes and raw materials, soliciting and incorporating feedback from the appropriate SMEs.
- Author and execute experiments for process development, characterization, & scale up following the principles of Quality by Design (QbD).
- Provide technical support for GMP manufacturing runs, supporting manufacturing through quality systems; deviations, CAPAs, & change controls.
- Perform process performance analysis and trend process performance.
Required Skills and Qualifications
- BS or MS degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related technical discipline.
- BS with 8+ years of experience or MS with 6+ years of experience in manufacturing sciences, process development, process validation, or related field.
- Prior experience with tech transfer, risk assessments, and quality systems in GMP environment.
- Prior experience with some or all of the following: single-use systems, tangential flow filtration, fermentation, lyophilization.
- Familiar with FDA and EU regulations and GMP standards.
- To be successful, you will possess sound understanding of engineering fundamentals, be independently motivated, able to work under aggressive timelines to achieve meaningful objectives, comfortable in a dynamic environment, detail oriented, and possess creative problem-solving abilities.
- We are looking for a person who meshes well with our culture – eager to dig into whatever work is needed, with a quick learning curve, and do so with high quality results. Collaboration and communication with laboratory and manufacturing colleagues is key!
Job Type: Full-time