VP of Manufacturing and Process Development
The VP Manufacturing and Process Development position is an important role in Cell Medica’s global cell therapy company. The successful candidate will provide leadership for the US cell therapy process development and process tech transfer activities, accountable for the full process development project lifecycle through to manufacturing. Ability to manage and prioritize several projects in parallel is key.
He/she will work in close association with the VP Manufacturing Operations (EU) to generate plans as well as oversee internal and external manufacturing operations and process development.
- Design, oversight, scheduling and execution of new process development and tech transfer experiments in the development setting, related to cell therapy process development projects and in-process analytics, to include automated platforms and analytics such as FACS.
- Critical analysis of processes for improved productivity and through-put utilising background and expertise in cell therapy manufacturing and knowledge of immunology to establish and optimize robust, characterized and well-controlled processes
- Accountable for analysis of data, generation of reports and tech transfer documentation as well as oversight on new development protocols, and IP disclosures when applicable. Technical writing to include final development report and CMC section or other regulatory submissions etc.
- Input to Product Development Plans and Portfolio Review
- Accountable for budget, meeting timelines and achieving timely deliverables, and clearly communicating results to cross-functional teams.
- Together with VP Manufacturing Operations (EU) ensure that a plan for manufacturing capability and capacity exists to meet company needs and is regularly reviewed and updated.
- Active participation in internal and external project teams
- Represent the company at external conferences and meetings
Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Investigate and communicate quality related issues to Quality and Senior Management.
Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensures that all team members comply with safety rules and regulations.
- Lead the Houston Process development and manufacturing operations team:
- Supervise and guide personnel
- Set goals and undertake reviews
- Recruit competent personnel
Education and Experience
Advanced degree (PhD preferred) in bio-engineering, biochemistry, molecular biology, immunology, virology or related discipline plus 10+ years of related bioprocess experience in an FDA-regulated environment. Outstanding technical writing and oral communications skills are mandatory.
- Must have thorough knowledge of cGMP requirements and facilities as it pertains to ex vivo gene-modified cell therapies. To put safety and product quality first
- Must have formal, demonstrable understanding of manufacturing for both autologous and allogeneic processes, including raw material qualification for clinical manufacturing.
- Solid understanding of and hands-on experience with in-process and final product analytical development for product quality monitoring is a must; FACS highly desirable.
- Ability to interpret and summarize complex scientific data and communicate in an accurate and concise manner
- Prior experience with cell therapy automation is desirable, as is prior cell therapy GMP experience.
- Prior experience in development of engineered T-cells or cell therapeutics is a plus.
- Experience with technology transfer and developing processes and technology for GMP manufacturing operations including closed processing, scale-up and scale-out.
- Experienced, hands-on, cost centre manager.
- Proven ability to lead and motivate a team of technical specialists.
- Demonstrated ability to deliver successful projects.
- Enjoys delivering technical presentations
- Understanding of QC techniques applicable for cellular products
- Experience in flow cytometry and other bioanalytical assays
- Knowledge of viral vector manufacture
- Experience of facility set-up and maintenance.
- A credible leader with demonstrated capability to manage, people and projects
- Capable of managing a wide range of tasks with minimal direction and prioritizing tasks accordingly
- Ability to recommend or take pragmatic actions to control risks
- Strong work ethic and desire to contribute to the growth of the organisation
- Strong attention to detail
- Highly self-motivated and able to motivate others
- Excellent written and verbal communication skills
Substantial portion of work is done in the laboratory environment. While working in the laboratory environment appropriate gowning, including safety equipment, is required as denoted for the designated area (i.e. lab coat, gloves, safety glasses). Some lifting of items up to 20 pounds. Exposure to potentially hazardous chemicals is possible. Eyes train and/or repetitive motion symptoms may occur due to use of the computer. Occasional extended daily or weekend hours may be required.