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Ferrara
Fairfield, CA, United States
Job Location: Fairfield Want to make an impact? The Sr. Director of Manufacturing is a hands-on leadership position that manages our Fairfield operation with overall responsibilities for team, production, maintenance, facilities, and safety. The Sr. Director of Manufacturing is a critical component of the leadership team, ensuring that our plant
Job Source: FerraraPolaris Pharmaceuticals Inc.
Vacaville, CA, United States
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 responsib
Job Source: Polaris Pharmaceuticals Inc.Toray Advanced Composites
Fairfield
Job Description Job Description ABOUT US: Toray Advanced Composites (TAC) is a leading supplier of advanced composite materials for the aerospace, sporting goods, motor sport and industrial markets. You will find our thermoset composite products on nearly every satellite, space launch vehicle, unmanned aircraft, military and commercial aircraft i
Job Source: Toray Advanced CompositesElve Inc
Davis
Job Description Job Description Who is Elve? Elve, Inc is a deep-tech startup in Davis, CA, whose patent-pending technology enables 100x faster wireless internet access in urban settings and remote locations. Elve delivers a transformative approach to the design and manufacturing of high-efficiency, lightweight millimeter-wave and near-THz RF po
Job Source: Elve IncAdvanced Technology Services
Yountville
Job Description Job Description Founded in 1985, ATS is a company with a presence in the United States, Mexico and the United Kingdom. We are professionals in Industrial Maintenance and we make factories run better. Fundada en 1985, ATS es una empresa con presencia en los Estados Unidos, México y el Reino Unido. Somos profesionales en mantenimie
Job Source: Advanced Technology ServicesRandstad Sourceright EMEA B.V.
Vacaville, CA, United States
*Candidates must be bilingual - Spanish/English - for this role. As a Manufacturing Talent Advisor you will be a strategic and consultative partner to our client’s Key Stakeholders and Hiring Managers with the responsibility of developing a university talent strategy that best suits the client's needs and market conditions. The position is ult
Job Source: Randstad Sourceright EMEA B.V.Jobot
Davis, CA, United States
100-120k+ This Jobot Job is hosted by: Kevin Saxby Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $100,000 - $120,000 per year A bit about us: Opportunity to work at a large and well known global manufacturing company Why join us? Health Dental Vision 401k PTO Long term & Short term disability
Job Source: JobotRandstad US
Vacaville
*Candidates must be bilingual - Spanish/English - for this role. As a Manufacturing Talent Advisor you will be a strategic and consultative partner to our client’s Key Stakeholders and Hiring Managers with the responsibility of developing a university talent strategy that best suits the client's needs and market conditions. The position is ultimate
Job Source: Randstad USVacaville, CA, United States
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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Email Alert for Director of Manufacturing jobs in Vacaville, CA, United States
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