I need a Production Manager from a sterile aseptic process manufacturing facility.
These type plants make Pharmaceuticals that go into the body and are liquids. Since they go into the body (not through the mouth) they would be injected. Companies that make vaccines, ophthalmic, nasal, Animal pharma doing injectable is fine also, and countless other drugs.
Manages the start-up and implementation of new aseptic production lines. Manages the daily operations of the new and existing lines to maximize the productivity of the department through optimum use of equipment, processes and personnel.
This role will manage the production department. This includes managing all operational aspects of the introduction of new production lines– validation, staffing, training, metrics, etc. Also includes planning efficient methods of production and ensuring that correct procedures are followed in compliance with regulatory and corporate policies.
Ensures the production schedules are met in support of customer demand.
Interprets administrative policies for employees, reviews supervisor’s performance and in conjunction with HR, makes decisions regarding personnel actions (hiring, terminations, promotions, etc.).
Directly responsible for supervising the daily activities of employees by providing training, direction, guidance, counseling or disciplinary action when necessary, and, in conjunction with HR, makes decisions regarding personnel actions (hiring, terminations, promotions, etc.).
Setting appropriate goals and objectives is required and tracking performance against agreed KPI’s.
The role includes planning efficient methods of production and ensuring that correct procedures are followed in compliance with regulatory and corporate policies.
The role will require teamwork and influencing skills both within the Operations function and with support functions such as Engineering, Maintenance and Quality Assurance.
This role is a critical leadership position in the organization. This role must drive a culture of quality in a pro-active manner where continuous improvement in all aspects of the operation is an on-going endeavor. A strong sense of ownership, accountability and urgency is required. Understanding the broader business requirements is essential.
The manufacturing operation is growing and presents significant opportunities for development and growth of the individual’s responsibilities.
Education - B.S. or B.A. in Business or Technical Field required
Experience: Supervisory Seven (7) years experience in supervision.
Experience: Certifications Green Belt certification or ability to become certified
Experience: IT Systems Proficient in Microsoft Word or Excel
Experience: Regulatory Experience in a pharmaceutical or medical device manufacturing facility.
Experience: Technical Experience in new product introductions, filtration, microbiological controls, aseptic processing, and complex operations.
Experience: Aseptic Five (5) years experience in aseptic processing in a FDA regulated environment preferred.
- In-depth understanding of pharmaceutical and/or medical device manufacturing environment.
- Thorough understanding of the CGMP requirements for operating in an FDA regulated environment and the ability to manage a production environment in strong compliance to these regulatory requirements.
- Demonstrated leadership and managerial ability.
- Ability to communicate effectively (verbal, written and presentation skills).
- Ability to work effectively with peers and supervisors.
- Analytical and problem solving skills.
- Detail oriented
- Excellent organization skills.
- Ability to manage multiple tasks.
- Knowledge of current aseptic processing techniques
Candidates from USA should be from US ONLY.
Please dont apply if you are not residing in USA
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