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Director, Manufacturing, Science

4 months ago

Vacaville, United States Polaris Pharmaceuticals Inc. Full time

Role Title: Director, Manufacturing, Science & Technology

Department: Manufacturing

Supervisor: COO and CEO

FLSA: Exempt


CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration


FUNCTION SUMMARY Director, MSAT


The Director of Manufacturing, Science, and Technology (MSAT), under minimal supervision, is responsible for developing a strategic vision and overseeing the MSAT group. The MSAT group is responsible for process development, process optimization, process scale-up, process transfer, manufacturing support, and process validation. This position will be required to communicate interdepartmentally in order to coordinate multiple activities related to MSAT and have the ability to take initiative without direct oversight. Thorough technical knowledge of biopharmaceutical manufacturing process and associated equipment including fermentation, column chromatography, and tangential flow filtration are essential. The Director of MSAT is expected to act as a mentor for MSAT personnel.


Duties & Responsibilities:


1) Lead the MSAT group to achieve company objectives and goals.

2) Provide technical input and support to the manufacturing team. This includes support for deviation investigations, resolution strategies, corrective and preventative actions, and process improvements.

3) Provide support to the MSAT Engineer responsible for process validation of products in late-stage clinical trials.

4) Oversee technology transfer of new products for the site.

5) Provide support to the MSAT Engineer responsible for process development and process optimization. Supervise the design and execution of experiments and the interpretation of results.

6) Provide solutions to complex biopharmaceutical manufacturing challenges.

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

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

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

11) Oversee the MSAT department budget.

12) Establish schedules and ensure resources are adequate to meet the demands of the MSAT schedule.

13) Develop and maintain a well-trained and efficient MSAT workforce. Evaluate the performance of direct reports and provide regular performance feedback and mentoring.

14) Represent the MSAT department during internal and external audits, including FDA Pre-Approval Inspections.

15) Responsible for talent management (recruitment, development, and retention) in the MSAT department.

16) Ensure a safe work environment for the MSAT group.

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


Skills & Competencies


  • Strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills.
  • Ability to perform responsibilities without supervision.
  • Thorough technical knowledge of biopharmaceutical manufacturing including microbial fermentation, protein purification, tangential flow filtration, and aseptic processing.
  • Proficiency in Windows, Microsoft Office Suite, or other organizational applications.
  • Good written, verbal, and communication skills.
  • Ability to coordinate interdepartmentally with Quality Control, Facilities, Manufacturing, and Quality Assurance for scheduling of MSAT related projects.


Education & Experience


BS/BA in Engineering/Science related field and at least 12 years of relevant experience is desired.

MS Degree in Engineering/Science related field and at least 10 years of relevant experience is desired.

PhD in Engineering/Science related field and at least 6 years of relevant experience is desired.