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.
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.
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
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
for budget, meeting timelines and achieving timely deliverables, and clearly
communicating results to cross-functional teams.
with VP Manufacturing Operations (EU) ensure that a plan for manufacturing
capability and capacity exists to meet company needs and is regularly reviewed
participation in internal and external project teams
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.
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
Ability to recommend or take pragmatic actions to control risks
Strong work ethic and desire to contribute to the growth of the
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. Eye strain and/or repetitive motion symptoms may occur due to use of the computer. Occasional extended daily or weekend hours may be required.