Director, Commercial Manuf Op GMP CDMO Cell Therapy Allendale, NJ ref

Director, Commercial Manufacturing Operations GMP CDMO Cell Therapy

The information below covers the role requirements, expected candidate experience, and accompanying qualifications.

Location : Allendale, NJ

Skills : GMP, CDMO, Cell Therapy, Strategic Planning, Project Execution

Experience Level : Director

Experience Required : 8 Years

Education Level : Bachelor’s degree

Job Function : Production

Industry : Biotechnology

Compensation : View salary

Total Position : 1

Relocation Assistance : No

Visa : Only US citizens and Green Card holders

OVERVIEW :

The Director, Commercial Manufacturing Operations is responsible for managing day-to-day operations of the department to ensure timely delivery of client-sponsored projects.

The incumbent is a change agent responsible for interacting with clients, providing strong technical leadership, and collaborating effectively across groups within the organization.

This managerial role provides leadership on the GMP and non-GMP facility environments and contributes to management goals and improvements.

RESPONSIBILITIES :

• Develop and adhere to Operations resource models, input into the development of prospective / existing client proposals, Manufacturing Service Agreement (MSA) and Scope of Work (SOW).
• Member of Site Leadership Team providing comprehensive formal and informal leadership to promote a positive work environment.
• Ensure safe, quality, and timely manufacturing of biopharmaceutical products for pre-clinical, clinical, and commercial use.
• Lead all aspects of Production Planning for the site.
• Ensure all production operations are controlled and executed within GMP regulatory guidelines.
• Develop and implement facilities policies and practices (SOPs).
• Deliver departmental goals and objectives based on compliance, milestones, and revenue targets.
• Accountable for tracking, trending, and improvement of the Operations KPIs.
• Provide strategic direction and set objectives to meet financial and operational requirements.
• Work directly with internal and external stakeholders on projects of existing and prospective clients.
• Collaborate with Quality Assurance, Quality Control, MSAT, Project and Account Management to ensure smooth tech transfer of client-sponsored projects.

QUALIFICATIONS :

• Bachelor’s degree or higher in relevant life science discipline.
• 8-10+ years’ direct experience in a GMP regulated facility in the pharmaceutical or biotech commercial manufacturing environment.
• 2+ years’ experience in cell processing, cell culture, and related GMP technologies.
• Significant knowledge and understanding of CDMO operations.
• Experience in strategic planning, process improvement, project execution, and data / business analytics.
• Excellent oral and written communication skills.
• Comprehensive understanding of GMP quality systems and procedures.
• Self-motivated and able to collaborate well cross-functionally.

WORKING ENVIRONMENT :

• Ability to work in a team-oriented environment.
• Exposure to infectious diseases transmittable through human blood, tissues, or bodily fluids.
• Comfortable in a clean room environment.
• Must utilize proper personal protective equipment (PPE).
• May be required to travel to other sites.

PHYSICAL REQUIREMENTS :

Regularly required to talk and hear; frequently required to stand, walk, use hands to finger, handle or feel, and reach with hands and arms.

SCHEDULE : M-F, Day Shift

M-F, Day Shift

J-18808-Ljbffr