Director, Encapsulation R&D (RI)

Job Description
Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 Diabetes, is seeking a director of encapsulation R&D to join its growing team. The full-time role will lead a group responsible for the development and implementation of processes to encapsulate Semma’s stem cell derived islets into its different delivery modalities. The position will report to the VP Delivery R&D and will be located in Providence, RI.

Responsibilities:

  • Manage a team including chemical engineers, biologists, and process technicians to develop and qualify processes used in the filling of Semma’s encapsulation modalities
  • Lead the industrialization of the encapsulation process, including optimization, scale up, and development of appropriate controls and assay release
  • Develop and implement characterization tools to be used downstream as in-process controls
  • Manage development contractors to design and implement equipment for purification, aseptic filling, chemistry, and other processes
  • Collaborate with internal groups on supply chain strategy, raw materials sourcing and vendor evaluation
  • Establish external collaborations to gain access to emerging manufacturing technologies and materials
  • Oversee the development of chemical modification processes for manipulating surface chemistries of the encapsulation systems
  • Lead efforts in documentation to facilitate tech transfer to manufacturing facilities, including developing appropriate protocols for IQ/OQ/PQ of encapsulation equipment and contribution to regulatory submissions
  • Maintain a keen eye toward process improvement opportunities including the identification of product failure modes and provide possible solutions through process modifications, and providing documentation and feedback for process development

Required qualifications:

  • PhD or MS in Life Sciences, Bio-Engineering, or related discipline with more than 8 years of commercial experience in aseptic cell filling, encapsulation, hydrogels, or related expertise
  • Experience in cell processing and harvest
  • Proven track record in developing implantable cell therapy systems
  • Demonstrated knowledge of biomaterials, implantation systems, devices, or tissue remodeling products
  • Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals
  • Demonstrated excellence in planning, executing, and analyzing experiments
  • Experience managing a small group
  • Ability to manage projects and forecast development activities through timelines and budgets to meet company goals
  • Authorized to legally work in US

Preferred qualifications:

  • Experience implementing GMP Manufacturing processes for a cleanroom environment including involvement in tech transfer
  • Authoring of IND or other regulatory submissions
  • Experience in developing automated manufacturing processes

Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.

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