Head of Commercial Manufacturing - Memphis, TN | Biospace
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Head of Commercial Manufacturing

Cognate BioServices, Inc.

Location:
Memphis, TN
Posted Date:
2/14/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, Cell Biology, Manager, Manufacturing, Manufacturing/Production, Operations, Pharmaceutical, Regulatory, Vaccine, Validation,

Job Description

Responsibilities:

•   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 inter-departmental 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

Desired Skills and Experience:

•   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
•   Must have a business-oriented mindset
•   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
•   Must possess strong analytical, numerical, and reasoning abilities
•   Positive, can-do attitude is required to effectively tackle problems and interface with the other functional areas of the company
•   Must be flexible and open to new ideas and strategies
•   Demonstrated ability to get results and lead innovation and change
•   Excellent oral and written communication and presentation skills are required