JOB OBJECTIVE: A hands-on management role responsible for leading the design and improvement of production processes for Promega’s biological manufacturing teams. Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines (cGMP) and compliance at all times. Ensures the effective use of materials, equipment, and employees in producing quality products. Formulates, recommends and implements manufacturing improvements, policies, procedures and programs. Aids in the technology transfer process from Research & Development to Manufacturing.
1. Provide technical and managerial leadership in all areas of responsibility.
2. Ensure compliance with all applicable corporate and regulatory SOP, cGMP, and safety guidelines.
- Effectively manage employee relations including hiring, discipline, rewards and recognition, and effective human capital resource allocation.
- Coach, advise, provide direction, educate, motivate, and oversee teams in the performance improvement process to increase manufacturing effectiveness in assigned areas.
- Set the appropriate priorities for the department and provide leadership for daily direction setting and problem solving in order to maximize results.
- Develop department goals that support the strategic goals of Operations and the entire Company.
3. Provide an integrated approach to process development through close collaboration with partners in Research, Marketing, Manufacturing, Quality Assurance and Regulatory Affairs.
4. Actively participate in the New Product Development process in a leadership capacity and as a hands on team member.
5. Support the development of analytical methods for manufacturing processes, intermediate and final products.
6. Perform strategic planning, budgeting and operations analysis within all areas of responsibility. Manage financial performance with budget controls, variance management, and capital management.
7. Maintain ongoing analysis of key issues, projects, and objectives, and provide regular written reports that include metrics to summarize the status and trends of key operational parameters.
8. Aggressively look for areas of manufacturing process improvement which may include additional capital investment, procedural revision or staffing changes.
9. Work with a cross-functional team to transfer technology from Research & Development to Manufacturing.
10. Collaborate with suppliers, vendors, and consultants to continuously improve manufacturing processes for the purpose of creating predictable and consistent procedures for manufacturing.
11. Demonstrate strong and consistent capabilities for innovation in all aspects of manufacturing processes.
12. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. Bachelor’s degree in biological sciences, biochemistry, bioengineering and/or related areas of study.
2. Minimum 7 years’ experience in process development related to pharmaceutical, biotechnology, or in-vitro diagnostic fields.
3. Minimum of 5 years manufacturing supervision/management experience.
4. Development of biological reagents in support of the life science markets.
5. Demonstrated experience in leading cross-functional project teams.
6. Strong communication and collaboration skills working in a matrixed environment.
7. Familiar with molecular separation and purification techniques such as chromatography, filtration, and membrane separation systems.
8. Experience with proteins, nucleic acids, buffer solutions, and small molecules.
9. Familiarity with scale-up of liquids through pumps, flow controls, etc.
10. Expertise in applying scientific methodology including root cause analysis, experimental design, and data analysis.
11. Demonstrated creative problem-solving skills to analyze and solve process challenges.
1. Aptitude for managing and supporting the growth of personnel (talent management).
2. Master’s or PhD degree in relevant scientific areas.
3. Chemical engineering experience.
4. Lyophilization technologies.
5. Experience with process automation and control systems.
1. Ability to work with computer equipment and telephone.
2. Ability to occasionally move/lift boxes weighing up to 30 pounds.
3. Ability to wear personal protective equipment.
4. Ability to travel internationally.
Promega Corporation is an Affirmative Action/Equal Opportunity Employer