Associate Director, Production, Infrastructure, and Operations, Template Control
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The Associate Director of Production, Infrastructure, and Operations in Template Control owns strategic planning for and execution of production deliverables, lab infrastructure and scale-up, production logistics and operations, facilitates process improvement initiatives, and supports new product transfer projects. These efforts support bioMérieux's in vitro molecular diagnostics research and development, manufacturing, validations, and quality control efforts. Principle responsibilities include developing and executing strategic plans for Production and Operations Teams to meet current and future product demands, maintaining lab infrastructure and onboarding equipment and instruments necessary to fulfill production and development project deliverables, administering the department process improvement program, and facilitating and strengthening interdepartmental support relationships to ensure the continued success of the team. Exceptional organizational and problem-solving skills, attention to detail, and commitment to bioMérieux’s corporate culture are essential for success as a senior member of our 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. Oversee general lab work and maintenance in accordance with cGMP/ISO/FDA standards.
3. Oversee material dispensation and inventory control in accordance with cGMP/ISO/FDA standards.
4. Maintain currency in company objectives, plans, priorities, and program agility in department operations.
5. Direct the Template Control production and operations teams via resource assessments and strategic planning for personnel, infrastructure, and materials based on production and development project priorities
6. Maintain clear department objectives grounded on corporate and program goals and execute plans and initiatives to meet those objectives.
7. Develop and maintain key performance indicator tracking and establish and support efforts to improve teams’ execution.
8. Train and develop Production and Operations teams’ management personnel and administer the teams’ training programs alongside managers.
9. Exemplify and inculcate BioMérieux’s positive corporate culture with production and operation teams.
10. Onboard and manage department lab and instrument infrastructure leveraging appropriate company support teams.
11. Guarantee uninterrupted supply of Template Control products via conservative inventory control, manufacturing scheduling, quality troubleshooting, scale-up projects, process improvement projects, and timely on-boarding of new processes and products.
12. Use appropriate tools to resolve process or product-related issues such as temporary deviations, rework procedures, non-conformance reports, etc.
13. Oversee quality investigations including problem identification, data analysis and review, corrections and corrective action, preventative actions, and timely completion of documentation leveraging nonconformance reporting.
14. Coordinate with team Managers, Supervisors, Project Managers, Scientists, Research Associates, and other personnel in new process/product implementations into Template Control.
15. Facilitate scheduling and resourcing of process improvement project studies, experiments, instrument, analytical method, and process validation efforts, and other tasks in support of department projects.
16. Originate, review, and support document revision efforts.
17. Other responsibilities and tasks as assigned.
Training and Education
• Bachelor’s degree (biology or chemistry preferred) and 8 years of relevant full-time work experience.
• Master’s degree/PhD in related field, and 5 years of relevant full-time work experience.
• 5 years of full-time experience in a management role required
• 2 years of work experience in the medical device industry required
• Familiarity with ISO 9001, 13485, MDSAP, 21 CFR 820 strongly preferred
• Familiarity with cGLP and cGMP strongly preferred
• Familiarity with PCR and its variants strongly preferred
• Professional certifications preferred, including Six Sigma, 6s, Kaizen, Lean, etc.
Knowledge, 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.
• Ability to develop, coordinate, and implement multi-level individual and team-based skills.
• Ability to organize, lead, and objectively evaluate the work of others.
• Leverage practical managerial skills, including computer literacy in database, spreadsheet, project management, word processing software, and enterprise resource planning infrastructure.
• Ability to write detailed and succinct reports, reviews, and manufacturing procedures.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to assimilate and advance bioMérieux’s corporate culture of purpose, opportunity, success, appreciation, well-being, and leadership.
Must be able to work at a desk for extended periods.
BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).