- The individual will serve as the pilot scale expert in Process Development and help to bridge from development scale to manufacturing scale in terms of process confirmation, process scale up, and equipment considerations.
- Manage activities of the US pilot lab, including both the upstream and downstream operations. Manage upstream and downstream direct reports to ensure runs are planned properly including raw materials and documentation. Provide guidance for critical operation decisions. Direct data analysis and ensure lab operations are streamlined and safe.
- Provide upstream/downstream scale up and operation support to PD Teams and Tech Transfer teams. Collaborate with ETS and Manufacturing on equipment operations, purchases and design.
- Guide centralized media/solution preparation services to support PDTS media/buffer need.
- Support cross functional initiatives regarding pilot lab operations and projects. Facilitate interaction and cross learning of US pilot group with EU pilot group and the development teams.
- The individual will work with a significant degree of independence, thus should possess excellent multi-tasking, problem solving, and communication skills/ability.
30 % – Manage staff
- Anticipate resource requirements, delegate appropriately, and assure work is prioritized and focused
- Foster teamwork and drive project/process improvements.
- Motivate and support the career development and expanding technical expertise
- Communicate company policies/goals/strategies/business results.
30 % – Manage pilot lab cell culture/purification and media preparation services. Leads pilot scale operation and experimentation to support process development needs. Evaluates new platform and technology as needed in collaboration with the development team. Contribute to tech transfer of multiple programs spanning all phases of bio pharmaceutical life cycle, including discussions of scale, equipment design and oversight of GMP, engineering and pre-clinical batches. Interacts with manufacturing operations staff, troubleshoots problems and supports their operations.
20 % – Writing, reviewing and approving of data summaries, technical reports, technology transfer packages, regulatory submissions and presentations.
10% – Continuous improvement for safe and lean lab operations.
10% – Organizational support and cross-functional project team leadership and participation. Advises senior management on goals and project direction.
Education and Experience Requirements
PhD (8+ years), MS (10+ years) or BS (12+ years) in Chemical/Biochemical Engineering or related discipline with relevant upstream and/or downstream process development experience in the biotechnology/pharmaceutical industry. An upstream process development background is preferred.
Recognized expert in upstream and/or downstream process development, optimization, scale-up, tech transfer; and manufacturing support. Strong background and knowledge in pilot operation management, equipment and engineering. Thorough knowledge of advanced scientific theories, concepts, experimental techniques and industry practices and standards. Keeps current with latest literature and technologies, including advanced computer applications. Proven record of technical leadership, including the ability to motivate and influence technical rigor.
Proven ability to work in a fast paced environment with demonstrated capacity to juggle multiple competing tasks and prioritize accordingly to meet program timelines.
Key Skills, Abilities, and Competencies
- Assess laboratory operations for effectiveness, efficiencies and safety
- Expert in upstream and/or downstream process development, scale up, pilot and manufacturing operations
- Knowledge of equipment design and performance assessment to be able to define user requirements and applicability to current and future processes at pilot and/or manufacturing scale.
- Develop strategies for process transfer to pilot and from pilot to manufacturing
- Ability to develop staff on technical knowledge and soft skills
- Ability to communicate clearly and concisely in verbal and in writing
- Team player with excellent interpersonal skills
Complexity and Problem Solving
- Ability to design and manage pilot operation strategies for a wide range of products at various development stages.
- Critical evaluation of results and tactical guidance to reach resolution to technical and operational issues
- Ability to drive multi-task in a fast-paced environment, with flexibility and strength to navigate through crises
- Assess needs, applyexperience and negotiate appropriate pilot lab equipment and process design that will facilitate technology transfers to the pilot lab and in turn to manufacturing.
Internal and External Contacts
• Pilot lab in EU, Process Implementation Experts, Upstream and Downstream Process Development technical leads, PD Operations leads; Internal Manufacturing, Safety, Quality, Engineering Technical Services
• CMOs, consultants, vendors as needed
Other Job Requirements
Some domestic and international travel expected (Less than 10%).
Req ID: R0018801