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Sr. Director Commercial Manufacturingcontact HARLAN Staffing
Job Description:

Head of Commercial Manufacturing Biologics

 

Responsible for the manufacture of cell‐based products, the orderly storage and flow of materials,

components and personnel

Must be capable of motivating others, creating a positive work environment and foster interdepartmental collaboration, coaching and performance feedback.

Must be capable of clearly assigning objectives, clearly setting and measuring and monitoring

progress, managing resources and handling competing priorities.

Ensure manufacturing equipment and facilities are operated and maintained in a compliant and safe

manner

Must be committed to continuous improvement, leveraging data and technology to maintain and

improve quality standards

Manage personnel to meet business, quality, and safety requirements

Ensure product quality and contribute to Quality investigations

Support change control activities where requested

Assist in troubleshooting manufacturing problems

Generate and maintain manufacturing equipment operational SOPs

 

Requirements:

A minimum of a BS in science or engineering or advanced degree (MS preferred), with at least 9 years of biologics manufacturing experience is required

Extensive experience with commercial manufacturing techniques related to highly complex biologics,

vaccines, or other relevant products

Leadership of organizational change, hiring and training

Demonstrated ability to formulate, implement, and manage complex GMP manufacturing processes for commercial applications. This includes knowledge of GMP facilities that meet technical and regulatory requirements

Expert knowledge in cGMP compliance for commercialization of biologicals is required

Cell therapy, Upstream, downstream and aseptic fill/finish

Strong interpersonal skills and demonstrated ability to communicate with a diverse team to bring about successful product release from production activities is a must

Generation and optimization of batch documentation

Experience taking the necessary steps to insure approval with pre‐BLA inspections

Experience with BLA filings

Demonstrated ability to get results and lead innovation and change

Excellent oral and written communication and presentation skills are required

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