Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking an associate director (AD) of device manufacturing to join its growing team. The full-time role will focus on leading efforts on the fabrication of cell encapsulation devices for delivering Semma’s proprietary cells, including development and qualification of processes used to make device material components as well as final assembly of the device. The AD will work closely with the Device R&D and Aseptic Filling groups to implement modifications to designs and processes. The position will be located in Providence, RI.
- Manage a small team of assembly personnel to develop and qualify processes used in the manufacturing of Semma’s encapsulation modalities
- Oversee manufacturing facilities including wet chemistry and clean space, including IQ/OQ/PQ of equipment and cleanrooms as necessary
- Actively participate in regulatory strategy including ISO-10993 testing, and authoring relevant CMC sections of regulatory filings
- Working with the Quality group to implement quality systems including ISO-13485.
- Author and oversee preparation of SOPs and quality documentation
- Develop and implement characterization tools to be used as in-process controls
- Work with Facilities Manager in supply chain strategy, raw materials sourcing and evaluation
- Establish collaborations with external vendors to gain access to emerging manufacturing technologies and materials
- Provide documented feedback for process development and improvement
- Identify product failure modes and provide possible solutions through product modifications
- Liaise with Semma’s fill-finish manufacturing group to provide feedback on cell processing
- PhD or Master’s in Life Sciences, Bio-Engineering, or related discipline with more than 3 years of commercial experience in manufacturing medical devices
- Demonstrated knowledge of biomaterials, implantation systems, devices, or tissue remodelling 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 corporate goals
- Authorized to legally work in US
- 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.