Single Use Technology Operations SME
Proclinical is currently recruiting for a Single Use Technology Operations SME with a top pharmaceutical company located in Sanford, NC. Successful candidate will develop and implement a strategy for use of single-use technology (SUT) in Stage 2 Gene Therapy.
- Develop and implement a strategy for use of single-use technology (SUT) in Stage 2 Gene Therapy.
- Review Stage 1 design and feedback from Stage 1 operations, as well as leveraging learnings and best practices from across company network currently using similar single use technology/equipment/designs.
- Leverage and enhance existing relationships with SUT vendors to support strategy for Stage 2 start-up and commercial cadence.
- Reduce the losses associated with SUT vendor quality issues and work in partnership with the vendor to identify, track and resolve those issues across the Sanford GTX facilities (GTX1 & GTX2)
- Execute work independently, work with various groups across the organization and oversee and lead projects to ensure goals of GTx Stage 2 project are reached.
- Partner with global engineering to develop and implement a strategy for use of single-use technology in Stage 2 Gene Therapy.
- Serve as point of contact between global engineering and Stage 2 Operations team in translating process requirements into SUT design Transfer knowledge of SUT design to operations team.
- Develop enrollment SUT enrollment strategy (sterile, packaging, expiry, and vendor suitability)
- Review and evaluate supplier complaint responses as required, identifying suitable CAPAs to address supplier quality issues across GTX1 & GTX2 operations.
- Provide in-depth technical expertise to support Supplier quality and technical issues.
- Act as the technical point of escalation for systemic quality issues originating from suppliers
- Collate and present data to suppliers at the quarterly Business Review Meeting and Biannual Supplier Relationship Meetings.
- Lead technical visits at suppliers to understand the supplier's manufacturing process and identify opportunities for improvements within these processes.
- Lead data driven CI initiatives and participate in specification alignment projects with Suppliers through technical solutions that lead to improved quality at the suppliers.
- Actively participate at Suite and Site Material Review Boards (MRB).
Skills and Requirements:
- BS degree with 3-5 years of experience required; MS degree with 1-2 years of experience preferred in any of the following disciplines: Chemical Engineering, Mechanical Engineering, Polymer Engineering or related science.
- Experience with designing single use technology (SUT) systems for biotech manufacturing
- .Hands on experience using SUT.
- Experience working with engineering on capital project, and project start-ups desired.
- Preferable to have experience in mammalian cell culture manufacturing.
- Experience in analyzing component defect/quality issues and working with suppliers to resolve the same desired.
- Ability to quickly understand the operating principles and risks of new technologies.
- Effective written and verbal communication skills.
- Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations.
- Strong interpersonal skills and experience working in a team environment across business functions.
- Independent, self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.