Product Development Engineer Senior Specialist
Semma Therapeutics
Job Description
JOB TITLE: Product Development Engineer Senior Specialist
LOCATION: 225A Carolina Avenue, Providence, RI 02905
OPENINGS: 1
DUTIES: Position will be responsible for offering a high level of technical leadership to process development and optimization, as well as for the characterization of cell encapsulation devices for ongoing and future projects; contribute to the exploration of NextGen technologies and establishment of new technologies; contributes to development of robust, scalable manufacturing processes for devices used in cell and gene therapies; lead process optimization in the support of process scale-up and scale-down models; evaluate novel and emerging technologies to advance project strategies; participate in technology transfer to CMO and provides manufacturing oversight for GMP production; apply relevant principles to process characterization, establishes process parameters, and contributes to CMC sections of regulatory filings; effectively collaborate with a fully integrated team to facilitate the success of projects; expanded conceptual knowledge and understanding of principles of wound healing and molecular and cell biology techniques; apply fundamental scientific and engineering principles to process design, development, and process understanding; and, apply statistical principles to guide process optimization. Travel required up to 10%.
REQUIREMENTS: Position requires a Bachelor’s degree (or foreign equivalent) in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Biological Sciences, or a related field plus six (6) years of experience in the job offered or in a related occupation. Alternatively, employer will accept a Master’s degree (or foreign equivalent) in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Biological Sciences, or a related field plus three (3) years of experience in the job offered or in a related occupation. Experience must include the following: • Demonstrable experience with process scale-up: including determination of cost of goods for manufacturing, management of contract manufacturers, development and validation of cleaning and assembly processes, equipment qualification, and optimization of in-process test methods; • Demonstrable experience with product development: Including design controls, risk analysis, and failure modes and effects analysis (FMEA); • Demonstrable experience with technology transfer; • Demonstrable experience with process transfer: Including cleanroom packaging and process development and validation and test method development; • Demonstrable experience with manufacturing oversight; • Demonstrable experience with statistical analysis and process optimization; • Demonstrable experience with manufacturing process and material flow; • Demonstrable experience with contributing to manufacturing sections within regulatory filings; • Demonstrable experience with CAD 3D modeling and drawings; • Demonstrable experience with Root Cause Investigations, CAPA’s, and change control; and, • Demonstrable experience with cGxP principles and practices, ISO 13485, ISO 14971, 21CFR.820. Travel required up to 10%.
CONTACT: Send Resume to Jessica Farley at Jessica_Farley@vrtx.com. Reference 12140.422. EOE.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.