Sr/ Director Cell and Gene Therapy GMP Operations – Analytical Testing

Position

The Sr/ Director Cell and Gene Therapy GMP Operations will be responsible for the overall operational management of

the Good Manufacturing Practices and Clinical Manufacturing Facility (GMP), including supervising

Study Directors, Project Management, Account Management, specific to analytical testing (e.g., gene

therapy, cell-based therapies, tissue engineering, and monoclonal antibodies). They will oversee all

day-to-day GMP operations, including project and timeline management, budget, personnel, P&L,

facility management, and Quality Control. They will be responsible for ensuring the GMP delivers

all services in a timely, compliant manner, while staying within budget.

Principal Duties and Responsibilities

 

 Directs the day-to-day operations of the GMP facility and all associated activities through

both hands-on activities and supervision of GMP staff.

 Works with the production line Scientific Directors to develop and enact strategic direction

for the GMP, including the determination of project priorities and timelines.

 Oversees all GMP resources, including production, facilities, and Quality Control, to meet

production goals in alignment with the objectives of the Scientific Directors and the strategic

plan.

 Is responsible for sound project and financial management of the GMP, including

preparation of and adherence to budgets and standards for cost measurement. Directs

operations so as to remain within approved budgets and timelines.

 Plays a strategic role in estimating future capacity, serving as primary liaison with suppliers and

purchasing staff.

 Manages and drives all operation related functions to optimize GMP efficiency.

 Supervises and assists in daily operational activities related to the GMP manufacturing of

biological products, including gene therapy vectors (e.g., Adeno-associated virus and

Lentivirus), live viral vaccines, cell-based therapies (cultured and genetically-modified

hematopoietic stem cells for clinical and investigational use in Phase I and II human clinical

trials), tissue engineering, recombinant proteins, and monoclonal antibodies.

 Develops and implements GMP policies and procedures that ensure production activities are

compliant with all governing regulatory, environmental, and safety directives.

 Ensures that appropriate and accurate documentation surrounding GMP activities supporting

product quality is maintained.

 Provides sponsors and collaborators with timely production status reports.

 Tracks daily workflow. Anticipates and resolves project issues.

 Is responsible for overall GMP staff performance, including hiring, providing feedback,

annual performance reviews, and termination if necessary.

Reporting Relationships

Reports to:  CEO.

Direct reports: Facility Manager, Production Director, and Quality Control Manager/Director.

Knowledge, Skills, and Abilities Required

 

 Must have demonstrated experience in GMP operations, an understanding of a variety of

GMP product lines, and knowledge in the scale-up/analytical testing of bio-therapeutics.

 Proven ability in analytical/bioprocess development to improve and refine analytical testing

and scalable production processes for testing in a GMP environment.

 Knowledge of regulations governing in the analytical testing of biopharmaceuticals as

mandated by governing bodies (e.g., FDA, International Conference on Harmonization of

Technical Requirements for Registration of Pharmaceuticals for Human Use).

 Minimum of 10 years of experience in analytical testing/bioprocess engineering or

bioprocessing.

 Advanced degree in biological sciences or engineering.

 Proven ability to improve analytical testing/biological process efficiency.

 Substantial experience in the direction and supervision of staff in a biotherapeuticGMP

environment.

 Experience in budget management and business development.

 Ability to make timely decisions.

 Ability to communicate clearly and efficiently

 Willingness to take ownership of all projects.