Boehringer Ingelheim is currently seeking a talented and innovative Pilot Plant Manager to join our Manufacturing Science and Technology department located at our Bedford, OH facility. As a Pilot Plant Manager, you will be responsible for managing the MST Pilot Plant, maintaining equipment and the facility, managing chemical and component inventory control, scheduling Pilot Plant activities and coordination of laboratory safety and training programs to ensure compliance with regulatory requirements. The position will serve as a liaison between the Product Development and MST technical staff, Quality Assurance and the customers of Ben Venue Labs and Bedford Labs.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies’ success.
We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s high regard for our employees.
Responsibilities:
- Oversees day -to-day laboratory activities including the purchase, maintenance and operation of essential technical manufacturing equipment. Schedules equipment and personnel to support department projects and business goals.
- Coordinates laboratory safety programs, working with in-house staff to ensure compliance with all OSHA, EPA and BVL EHS regulations.
- Establishes and maintains the systems and processes that assure facility compliance with cGMP and BI regulations and practices for a development pilot plant facility.
- Assures that the laboratory staff is properly trained in Standard Operating Procedures (SOPs) for performing laboratory functions, equipment operation and documentation.
- Develops personnel and technical competencies associated with the manufacture of Small Volume Parenteral pharmaceuticals.
- Maintains the laboratory facilities by serving as a liaison with the physical plant maintenance support groups.
- Reviews and approves technical protocols, SOPs and validation documents.
- Assists upper management in creating and maintaining the budget for supplies and equipment.
- Assists in the preparation and review of process development sections of regulatory filings.
- Conducts laboratory tours for clients and auditors, as requested by QA or Contract Services.
Requirements:
- Requires a Bachelor of Science degree in Engineering or related scientific degree. A specialization in Process, Industrial or Chemical Engineering preferred.
- Minimum 10 years experience in the development and manufacturing of small volume parenteral pharmaceuticals. Requires a minimum of 5 years managerial experience.
- Requires a demonstrated knowledge of formulation concepts and experimental design.
- Proficiency in the use of Microsoft Office products including project planning techniques and software.
- Working knowledge of federal regulations governing the pharmaceutical industry including SOPs and cGMPs.
- Requires excellent communication, investigative and implementation skills.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V