Director of Manufacturing

2 weeks ago

Vacaville, United States Polaris Group Full time

Role Title: Director of Manufacturing

Department: Manufacturing

Supervisor: COO and CEO

FLSA: Exempt

CORE VALUES

Respect ? Passion ? Teamwork ? Integrity ? Honesty ? Commitment ? Collaboration

FUNCTION SUMMARY Manufacturing Director

The Director of Manufacturing is responsible for developing a strategic vision and overseeing the manufacturing department, drug product manufacturing, and implementation of new drug products while complying with cGMP regulations. The Director of Manufacturing will maintain a department budget, guide production management, on personnel/project development, and improve department organization. The Director of Manufacturing is expected to obtain a strong understanding of the manufacturing process and equipment, and other site quality systems. This position will be required to communicated interdepartmentally to coordinate multiple activities related to manufacturing and have the ability to take initiative without direct oversight. Knowledge of processes including fermentation, column chromatography, and tangential flow filtration are highly desired. The Director of Manufacturing is expected to act as a mentor for all manufacturing personnel, and as a lead during manufacturing audits.

Duties & Responsibilities:

1) Help lead the transition from a clinical drug manufacturing company to a commercial drug manufacturing company. Implement cultural and organizational changes when needed, implement operational excellence and lean manufacturing for continuous improvement. Prepare the manufacturing group for a Pre-Approval Inspection from the FDA.

2) Lead the manufacturing department to achieve company objectives and goals.

3) Oversee the manufacturing of drug products and implementation of new drug products.

4) Create and improve manufacturing process strategies while complying with the cGMP regulations.

5) Obtain a strong understanding of the manufacturing process and equipment operation.

6) Develop and recommend manufacturing equipment and process improvements to support future business strategies.

7) Oversee the manufacturing department budget.

8) Assist with the development of the Manufacturing budget.

9) Provide guidance and oversight of production management.

10) Establish production schedules and ensure resources are adequate to meet the demands of the production schedule.

11) Work and communicate collaboratively with internal and external staff.

12) Develop and maintain a well-trained and compliant manufacturing work force. Evaluate the performance of direct reports and provide regular performance feedback and monitoring.

13) Provide guidance and insight for deviation investigations, resolution strategies, CAPA implementation, and material review board decisions.

14) Communicate with vendors regarding raw materials or services.

15) Represent the manufacturing department during internal or external audits, including FDA Pre-Approval Inspections.

16) Responsible for talent management (recruitment, development, and retention) in the manufacturing department.

17) Ensure a safe work environment for the manufacturing group.

18) Perform other company duties as required by Executive Leadership.

Skills & Competencies

  • Performs tasks associated with maintaining cGMP compliant manufacturing department.
  • Strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
  • Ability to perform responsibilities without supervision.
  • Proficiency in Windows, Microsoft Word, Excel, Microsoft Teams, or other organizational applications.
  • Good written, verbal, and communication skills.
  • Ability to coordinate interdepartmentally with Quality Control, Facilities, MSATs and Quality Assurance for scheduling.

The Director of Manufacturing must develop the skills necessary to organize and lead the manufacturing department to achieve company objectives and goals. The Director of Manufacturing candidate is desired to have previous experience with manufacturing of recombinant protein therapeutics, managing direct reports, projects, and commercial manufacturing, and have participated in regulatory audits.

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