Senior Engineer, MSAT – Early Phase
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.
Job Summary
Seres Therapeutics is seeking a highly motivated Senior 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. The successful candidate will take a lead technical role in the identification and implementation of continuous improvements aimed at consistency and robustness, working closely with Manufacturing Operations to ensure robust, compliant cGMP manufacturing performance. 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.
This role will be responsible for ensuring a robust, scalable and efficient manufacturing processes to produce late-phase clinical trial drug.
Responsibilities
- 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.
- Project leadership: manage timelines and deliverables from project ideation through completion.
- 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.
- Make decisions regarding product impact
- Maintain manufacturing performance metrics. Regularly review and assess manufacturing performance.
Required Skills and Qualifications
- BS or MS degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related technical discipline.
- BS with 6 years minimum, 8+ preferred of experience or MS with 5+ 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.
- Expert in single-use systems, tangential flow filtration, fermentation, lyophilization.
- Working knowledge of industry standard practices, FDA and EU regulations and GMP standards.
- Working knowledge of statistical analysis methods.
- 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!