Manufacturing Process Engineer, Leading Stem Cell/Regenerative Biotech: Work from home, Memphis, TN area
Cornerstone is working exclusively with an attractive, leading Stem-cell focused Biotech company as they continue to grow their manufacturing capabilities here in the US. This is an excellent opportunity to join a sponsor-side company and leverage/utilize your experience gained at a CMO. This role will allow you to have responsibility of oversight for stem cell process engineering, manufacturing operations, tech transfer and partnering while working alongside a close-knit strong team. You will have the ability to grow and further your career while gaining invaluable experience.
Our client is looking for someone that is driven to further develop themselves and that prefers a more all-encompassing role as opposed to being on the floor in a more narrowly focused position. This is an excellent opportunity to jump-start your career and gain big picture/strategic experience that will lead you to further exciting opportunities within the company as you develop.
- Provide process input to the engineering, qualification and validation for functional areas on new and existing stem cell manufacturing facilities / processes in compliance.
- Provide technical input for process fit assessments within existing manufacturing facilities and to define process requirements for new manufacturing facilities.
- Provide ongoing technical support for change control, deviation investigations and CAPA management as required during development and commercial manufacturing of products in the portfolio.
- Ensure that all manufacturing steps are reviewed and maintained to regulatory requirements.
- Contribute to the knowledge base of the manufacturing team to utilize external and internal networks to identify resources and build partnerships in the areas of process technologies to drive best in class manufacturing operations.
- Manage the operational/daily technology transfer from process development to cGMP manufacturing and across site transfers of commercial manufacturing processes as required meeting global demand forecasts.
- Lead site specific tracking and continuous analysis of process-related data.
- Monitor the appropriateness of critical raw material supply, including serum procurement.
- Lead implementation of process changes through change control process and ensure efficient implementation at the CMO.
- Monitor the sites performance to ensure that the agreed project timelines are met.
- Report issues or delays within a timely manner to ensure the issues are identified and resolved.
- In regular consultation with the defined partner to ensure the manufacturing goals of process and product output is achieved as per the agreement.
- Contribute and support partnering with Development Teams and Site Operations; Engineering
- Teams at CMOs to generate and execute process / product technology transfers to meet strategic manufacturing growth initiatives.
- Support Global Initiatives to drive manufacturing.
- Act as the process development lead for process development related activities within the CMO.
LOCATION: This position is remotely-based, but must be located within driving distance of Memphis as there will be some travel to the CMO site.
EDUCATION & EXPERIENCE:
- BSc in Biochemical/Biological related field or Chemical Engineering or Process Engineering.
- 3 years of experience providing engineering and/or process input of drug product manufacturing
- operations to meet process compliance and regulatory requirements.
- Minimum of 3 years of experience in stem cell based closed system process engineering.
Thomas Fascia | Partner
P: 973-656-0220 x717
CORNERSTONE SEARCH GROUP – Pharma & Biotech Executive Search
Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA