Process Transfer Engineer
To independently lead the technical transfer of multiple concurrent manufacturing processes (either Cell Culture and/or Purification – USP/DSP) from Process Development, Pilot Scale and other sites of manufacture to GMP operations in Hayward. The role will be a recognized process expert. Supporting multiple customer project teams to deliver manufacturing processes in negotiation with external customers as well as other internal cross-functional teams. This role has the opportunity to develop an extensive internal network. Building influence and credibility in the industry. In addition, the role will act as a coach/mentor to more junior team members and cross functionally as a Subject Matter Expert (SME).
- Represents and is an influential MSAT team member within multiple customer facing project teams using a standard methodology/procedures to successfully transfer complex processes into USP and/or DSP GMP manufacturing from international process development and pilot scale facilities.
- Be accountable for the management of technical risks associated with process transfer, identification & introduction of new raw materials for pilot and production scale batches and work cross functionally to ensure communication of all critical process and technical information to meet the required deadlines/customer outcomes.
- Actively communicates, presents data, negotiates and collaborates with the customer via both face-to-face meeting and teleconferences.
- Accountable for independent 24/7 on plant technical support, process monitoring and complex data analysis. Responsible for delivering effective operator training for critical unit/process operations and off line completion of quality actions (e.g. deviations, change controls, CAPA’s) working effectively in cross-functional teams to deliver required outcomes.
- Contributes to the immediate resolution of identified manufacturing process issues through use of knowledge and experience, leading technical investigations to ensure continuous improvements are made to the GMP manufacturing processes and operations. Will work with SMEs to develop knowledge base, deepen process understanding and advise as needed junior level team members on specific technical problem resolution through sharing key knowledge.
- Proactively anticipates, evaluates and resolves technical challenges within area of expertise. Is self-managed in preventing deviations in unit operations including interaction and strong communication with both internal and external team(s). (NEW PARA) Understands and looks to introduce new technologies and how they may be applicable to process innovation, cost or yield improvement.
- PhD/EngD or equivalent means of demonstrating ability with experience in industry Masters in Biotechnology
- Biochemical Engineering /Chemical Engineering
- Has knowledge in field of expertise either from laboratory development or a manufacturing operations background and on the job training, working as either as an individual contributor or as a strong team player.
- Demonstrated experience in process transfer
- Demonstrated knowledge in USP and/or DSP operations from working in a GMP environment. Ability to technically understand complex non routine unit operations with a proven track record of successful technical transfer expertise. Has a deep understanding of manufacturing processes.
- demonstrated interpersonal skills
- Problem solving skills, developing solutions to problems not previously seen
- Proven problem solver, implementing improvements, has an excellent technical attention to detail, communication skills both written and verbal, interpersonal qualities with a continuous improvement positive mind set.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.