Device Analytical Development Supervisor
The Supervisor will manage a team within VCGT Device Analytical Development focused on routine testing of samples from the Pilot Plant and Manufacturing. The team will also work closely with the Device QC Team on OOS/OOT investigations from clinical manufacturing. This role is critical to bringing transformative therapies to patients at the highest level of safety and quality.
Lead a team of 2-4 scientists in the execution of key technical operations activities, mainly through testing of incoming materials, in-process control, and final products for the pilot plant.
Troubleshoot, optimize, and trend assay and process performance
Establish protocols and procedures for receipt and reporting of routine device and incoming material test samples.
Report on project progress, write analytical development protocols and reports, participate OOT and OOS investigations and provide recommendations to project teams
Oversee routine maintenance and qualification of analytical instrumentation in the lab
Ensure the accuracy and integrity of analytical data generated by the technical operations team.
Maintain excellent written documentation (GDP) and review of team data (e.g. ELN and test forms) prior to reporting.
Education requirement and/or experience:
Bachelors Or Masters Degree in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline and 5+ years of industry experience or education.
Knowledge and Skills Required:
Advanced knowledge in at least one of the following methods or areas: FTIR, TGA, DSC, porosity/flux, Chromatography (HPLC/GC), Mass Spectrometry, ICP-MS or mechanical material characterization (e.g. hardness, viscosity, stress/strain curves).
Experience in development and troubleshooting of analytical methods.
Project or people management experience and an ability to manage competing priorities.
Effective communication skills for collaboration across teams
Knowledgeable in the procedures required to investigate OOS and OOT results.
Excellent communication skills with a proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team
Experience with sample management and electronic documentation systems in the GMP environment is a plus.
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.