Description Job Summary
The Manager of the Template Control Production team will supervise a team that formulates DNA, RNA, and microbiological components to support bioMérieux's in vitro molecular diagnostics research and development, manufacturing, validations, and quality control efforts. Principle responsibilities include management of personnel including hiring, training, and professional development, overseeing staffing logistics for production and research events, ensuring product quality and adherence to cGLP/GMP and quality system requirements, facilitating process improvement research and implementation, coordinating preventative maintenance and calibration for lab instruments and equipment, and executing validations for new production processes, products, instruments, and equipment. Works in concert with the Template Control Operations, Projects, and Innovations teams. Exceptional organizational and problem-solving skills, attention to detail, and commitment to bioMérieux’s corporate culture are essential to successfully manage this team.Essential Job Duties and Responsibilities
1. Perform all work in compliance with company policy and within the guidelines of bioMérieux's Quality System.
2. Manage the Template Control production team, including interviewing, hiring, and training personnel, providing performance feedback and reviews, and exemplifying bioMérieux’s corporate culture.
3. Manage team timesheet, PTO reviews/approvals, and track attendance.
4. Oversee general lab maintenance, CAL/PM performance, and general lab operations.
5. Support projects, studies, experiments, data collection, and accurate record keeping in accordance with cGMP/GLP practices and in collaboration with TC Operations, Innovation, and Project Management teams.
6. Manage dispensation and inventory control of production subassemblies in collaboration with TC Operations Team.
7. Manage production of Template Control products, including inventory, manufacturing, resource allocation, troubleshooting, quality control, and ramp-up, in collaboration with TC Operations, Projects, and Innovations teams.
8. Work closely with support departments to ensure uninterrupted supply of Template Control products, resolving process/product-related issues using tools such as temporary deviations, rework procedures, non-conformance reports, raw material procurement contracts, etc.
9. Support quality investigations including problem identification, data analysis and review, corrections and corrective action, preventative actions, and timely completion of documentation.
10. Coordinate with Template Control Operations, Innovation, and Project Management teams in new process/product implementations into Template Control, process improvement implementation, new equipment validation, and document revisions.
11. Sustain a kaizen mindset in supporting production-adjacent projects via the TC Improvement Incubator program.
12. Make detailed performance observations, compile and analyze production metrics, interpret results, and effectuate action plans under the direction of TC leadership.
13. The Manager, Template Control Production will receive general instruction on routine work, perform and oversee lab duties with minimal supervision, and receive training and additional instruction for new tasks as needed.
14. Performs other duties as assigned.QualificationsTraining and Education
• Bachelor’s degree (biology or chemistry preferred) and 5 years of relevant full-time work experience.
• Master’s degree/PhD in related field, and 3 years of relevant full-time work experience.Experience
• 3 years of full-time experience in a management or team-leadership role required
(Graduate degree in business or physical science may substitute for additional experience as appropriate)
• 3 years of work experience in the medical device industry preferred
• Familiarity with ISO 9001, 13485, MDSAP, 21 CFR 820 desired
• Familiarity with PCR and its variants desired
• Proficiency in bioinformatics programs, specifically those related to PCR preferredKnowledge, Skills and Abilities
• Ability to utilize well-developed interpersonal communication skills and practiced emotional intelligence to successfully relate with and motivate personnel at all organizational levels.
• Excellence in leadership, delegation, organization, persuasion, training, and feedback.
• Ability to develop, coordinate, and implement multi-level individual and team-based skills.
• Ability to organize, lead, and objectively evaluate the work of other personnel.
• Leverage practiced managerial skills, including computer literacy in database, spreadsheet, project management, and word processing software.
• Ability to write detailed and succinct reports, reviews, and manufacturing procedures.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Flexibility and agility in shifting priorities, reallocating resources, and meeting timelines.
• Manage multiple, often conflicting, priorities simultaneously with minimal supervision.
• Demonstrate high-level business judgment and clear communication with cross-functional teams and others at all levels of the organization.
• Ability to assimilate and advance bioMérieux’s corporate culture of purpose, opportunity, success, appreciation, well-being, and leadership.Physical Requirements
Must be able to work at a desk for extended periods.