Process Technology Specialist
Our client is currently looking for a Process Technology Specialist to join the Process Transfer subdivision of the Process Development team. This is an exciting opportunity to help lead the effort of Upstream (Cell Culture) Process Transfer from Process Development into Manufacturing. Additionally, this position is responsible for the transfer and implementation of new technologies and new systems into GMP operations, providing the candidate with the opportunity for leadership in technical problem solving and developing interdepartmental relationships (customer service).
- Serve as the manufacturing representative on client project teams; this includes the ability to interface extensively with the client.
- Lead Process Transfer activities to transfer processes from Process Development to Manufacturing. This includes driving the entire effort of drafting and revising manufacturing batch records and key SOPs for the integration of new processes within manufacturing.
- Serve as a key manufacturing representative on project teams as a representative to identify, define and provide user requirements for process equipment associated with multiple facilities for the manufacture of biotechnology APIs.
- Provide high-level technical leadership to Manufacturing and other departments associated with GMP operations.
- Must be recognized as the technical expert: Serve as Subject Matter Expert (upstream) to troubleshoot processes and equipment during investigations or cycle and process development on the manufacturing floor.
- Participate in the project team meetings, decisions and creation of milestones representing manufacturing operations
- Help lead the engineering effort to acquire process equipment from design through procurement, installation and operational readiness, and associated required GMP documentation.
- Serve as the key person to identify viable new technologies to improve manufacturing capabilities.
- Prepares and presents data associated with manufacturing processes to internal and external clients. May serve as the escort during Person-in-Plant activities.
- Build effective working relationships with QA, Process Development, Project Management and Business Development to support new processes and products.
- Other duties as assigned.
- Bachelor’s Degree or equivalent work experience
- Minimum of 5+ years of directly relevant experience
- BS in engineering or science preferred
- Experience with bringing biotechnology equipment and processes from design through GMP operational readiness
- Must be self-motivating, organized and proactive in order to coordinate the multi-departmental tasks and deliverables (interaction with PD, Eng., QA, QC, etc.)
- Should require little to no direct supervision
- Experience successfully managing multiple projects
- Experience serving as Lead in troubleshooting efforts
- Experience providing technical training to others on GMP manufacturing operations
- Communicate clearly, efficiently and accurately with internal and external customers
- Experience with and understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., ICH Q7A, 21 CFR Part 211, etc.)
- Experience writing, reviewing and approving GMP documentation
- Should have strong presentation skills
- Strong technical aptitude including the demonstrated experience of applying scientific reasoning to solve complex problems
Employee Bonus Program
Life & Disability