Full Time / Direct Hire
University - Bachelor's Degree/3-4 Year Degree - pharmacy, microbiology, engineering, or relevant scientific discipline
Why is This a Great Opportunity*
We are looking for a Production Manager to be responsible for overall manufacturing and packaging. Major responsibilities include plant startup activities, such as building teams, qualification of equipment, setting up plant systems and processes, site transfer of manufacturing processes, media fills, maintaining aseptic manufacturing areas and manufacturing of exhibit and commercial batches. The Production Manager will ensure that manufacturing and packaging operations are carried out in compliance with all statutory and regulatory requirements in an effective and time-sensitive manner.
* Budget preparation and compliance for the operations and Capital expenditure projects of the Sterile areas.
* Keeping the manufacturing costs within established budget.
* Plant wide OEE initiatives to enhance the overall efficiency of the Sterile areas.
* Shall lead and coordinate the continuous improvement opportunities across the Sterile areas.
* Responsible for leading change with ability to negotiate and influence positive outcomes.
* Ensuring that the manufacturing capacities are periodically reviewed and prepare and implement capacity additions when required.
* Collaborate with other departments, such as Procurement, Quality Control, Quality Assurance, Regulatory, and R&D to effectively run the operations.
* Coordination with the teams and other manufacturing locations to ensure the projects, product filings, product launches, commercial supplies etc., are done in the most efficient way.
* Lead for the preparation of regulatory and customer audits for the Sterile areas.
* Develop the team and people development through training and talent management programs.
* Control the attrition within the target.
* Design or Implement manufacturing processes that support business strategies adapted to changing market conditions, new business opportunities or cost reduction drive.
* Take up energy conservation projects.
* To develop and monitor productivity matrices and to improve these over the time.
* To initiate and accountable for the safety management system of the Sterile areas.
* A Bachelor's degree in pharmacy, microbiology, engineering, or relevant scientific discipline is required for consideration of this position.
* A Master's degree in one of the listed fields is preferred.
* A minimum of eight (8) years of experience in pharmaceutical manufacturing is required for consideration for this position.
* Experience in sterile or aseptic manufacturing is required.
* Experience with working in USFDA regulated manufacturing facilities is required.
* Ideal candidate will have experience in Blow, Fill, and Seal technology.
Knowledge & Skills:
* Demonstrated understanding of all applicable manufacturing process technology, equipment, unit operations and control technology.
* Change Agent, Servant Based Leadership.
* Demonstrated commitment to continuous improvement and methodologies, Formal Operational Excellence training is preferred.
* Strong hands-on experience of media fills and aseptic manufacturing is required.
* Functional knowledge of pharmaceutical manufacturing processes is required.
* Hands on experience with Blow, Fill and Seal technologies highly preferred.
* Demonstrated working knowledge and understanding of conceptual, detailed design, project planning, execution and qualification of biopharmaceutical facilities as per cGMP requirements.