VP of Manufacturing and Process Development


Houston, Texas, United States of America

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.

Responsibilities


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

Quality Responsibility

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.

Safety Responsibility

Is knowledgeable and complies with all pertinent
safety policies, rules and regulations. Ensures that all team members comply
with safety rules and regulations.

Leadership Responsibility

§
Lead the Houston Process development and manufacturing operations team:

o
Supervise and guide personnel

o
Set goals and undertake reviews

o
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

Desirable


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.

Personal Attributes


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

Working Conditions

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.


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