Capital Associated Industries, Inc.
  • Raleigh, NC, USA
  • Full Time

The Director of Manufacturing Operations, will have responsibility for managing operations related to the clinical and commercial manufacturing of the Cellectis cell and gene therapy products at the U.S. manufacturing facility. The position will have the responsibility to ensure smooth, continuous, cost effective, and compliant product manufacture to meet demand and assure divisional and corporate goals are achieved.

 

Responsibilities:

 

  • Accountable for site manufacturing management at the Cellectis U.S. manufacturing site.
  • Responsible for overall manufacturing strategy including appropriate staffing, capacity utilization, resource allocation, budget management and cGMP compliance.
  • Works with Quality and the Leadership team in the implementation of Quality and Business processes required to assure compliant cGMP manufacture of products in either a clinical or commercial setting.
  • Monitors manufacturing capacities and communicates capabilities through monthly metric and business review reporting.
  • Accountable to assure staff has the proper training, skill set, and personal development opportunities to assure their ability to carry out assigned tasks in compliance with procedures and policy as well as local, federal and global regulations and industry standard.
  • Assures the development, execution and monthly tracking and reporting of assigned operational metrics.
  • Works with Quality Assurance, MSAT, Project Management, Supply Chain, Engineering and Facilities to ensure timely and compliant approvals of manufacturing changes through proper change control.
  • Develops and implements a continual Audit of the department for GMP compliance.
  • Works with the EH+S Manager to assure environmental and OSHA compliance by developing appropriate safety, compliance, quality, and other relevant policies, procedures, goals and metrics.
  • Accountability for ensuring the plant consistently meets all cGMP and other regulatory requirements.
  • Assures operations area is kept in a cGMP state of repair through coordination of preventive maintenance and cleaning activities with the Facilities department.
  • Responsible for ongoing development and improvement of the infrastructure necessary for the assigned plant to effectively and efficiently deliver against its vision, strategy, plans and objectives.
  • Builds a world-class team, develops talent and ensures a robust succession plan is in place, at all times for key positions in the plant. Develops a continuous improvement culture within the team.
  • Drives and oversees regular and ad hoc risk assessment and mitigation planning and management.
  • Leads and/or participates in various cross-functional teams or committees, e.g. Quality Council, S&OP, Safety Committee
  • Develop and execute plans to meet or exceed manufacturing efficiency targets.
  • Interface with senior managers, peers and direct reports to maintain mutual understanding of product design needs, regulatory and production requirements.
  • Works closely with internal and external colleagues on projects of existing and new products to ensure appropriate capacity, proper quality, and adequate sourcing of critical components.
  • Works to assure annual budget targets are met by overseeing financial responsibilities which are within the positions control such as staffing, line item expense, capital requirements, capacity utilization
  • Works with MSAT to ensure smooth tech transfer of new products.

 

Knowledge & Experience:

 

  • Understand requirements pertaining to aseptic manufacture of cellular and gene therapy products.
  •  Bachelor's degree in life sciences or an engineering discipline.
  • Minimum of 15 years of relevant experience of which at least 5-10 years in a Senior Management role overseeing a manufacturing environment with applicable clinical or commercial experience.  Management of an aseptic biologics manufacturing facility is preferred 
  • Strong understanding of sterilization processes, equipment, clean rooms, processes, designs, etc.
  • Deep understanding of current Good Manufacturing Processes (cGMPs) and Good Laboratory Practices (GLPs).
  • Working knowledge of financial operations in a manufacturing environment
  • Knowledge of aseptic processing and supporting technologies.

 

Candidate Profile:

  • Familiarity with the product development process for biological products is helpful.
  • Background in lean, six sigma or other continuous improvement methodology desired.
  • Highly intelligent, perceptive individual who possesses excellent conceptual, analytical, and problem-solving ability.
  • The ability to effectively interface with peer group in the Company and work collaboratively to achieve company goals.
  • Collaborates with other team members and demonstrates outstanding interpersonal skills.
  • An ability to recruit, lead and develop a high-performance manufacturing organization.
  • Ability to work autonomously in an entrepreneurial, fast paced environment.
  • Strong business acumen
  • Ability to think strategically and tactically (detail-oriented)
  • Analytical and problem-solving skills
  • Strong written and oral communication skills
  • Flexible and able to adapt to company growth and evolving responsibilities

 

 

 

 

Capital Associated Industries, Inc.
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