Director Template Control Manufacturing

Description

Job Summary

The Director of Template Control (TC) supervises the TC department and reports to the Senior Director of Technology Transfer. Template Control is a manufacturing focused team comprised of Production, Production Operations, Process Improvement, and Project implementation.

The Director of Template Control is responsible for management of the Template Control Department, including personnel, processes, and physical resources. They will establish department infrastructure, hire, train, and mentor the associate director and the manager of projects.  They, in partnership with the associate director and under the guidance of the Sr. Director of Technology Transfer, will be responsible for prioritization of the project requirements for the department.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Develop and support team of project managers under the Manager of TC Projects who are responsible for document/process revisions related to process improvements, scale-up projects, and the transitions of new products into the Template Control group.
3. Work closely with R&D support groups to identify and prioritize development work required for innovating Template Control manufacturing processes, test methods, raw materials, consumables, instruments, and process workflows to increase product performance, consistency, quality, and scale.  R&D work is conducted by the development teams.
4. Develop and support production and operations teams under the associate director to ensure quality of product and uninterrupted supply of TC parts to Reagent Manufacturing and Reagent QC, including Omega mixes, PCR controls, yeast process controls, QSM, and synthetic template materials for all panels. In addition, this team will provide R&D with development materials as requested.
5. Ensure all template material requirements to support the manufacturing/QC/development efforts are delivered in full, on time, and in accordance with the BMX quality system.
6. Ensure collaboration with Biochemistry R&D, Molecular Systems, BioMath, Quality Assurance, Technology Transfer Product Transfer, Program Management, Reagent Manufacturing, and Manufacturing Support teams to ensure seamless transitions and minimize potential impact to regulatory issues and manufacturing processes.
7. Evaluate and review direct reports.  Works with each to create development plans and goals, facilitates further training and education, and empowers them to ensure their success and the realization of department objectives.
8. Maintain and update multi-year department strategic plans and budgets for personnel, projects, capital expenditures, and IT infrastructure, and aligns these with company objectives.
9. Establish department key performance indicators (KPIs) to surveil operational efficiency and effectiveness of improvements, and regularly provide updates on these metrics to upper management.
10. The Director, or an appointee on their behalf, will be responsible for providing Template Control feedback at meetings focused on reviewing performance trends or development of new manufacturing templates or procedures.
11. Will rely on extensive experience and judgment to plan and accomplish goals.
12. Will lead and direct the work of others.
13. The Director will be the primary contact point for all audit activities within the Template Control department.
14. Generic supervisory duties, including:  Delegate duties and assure understanding of same; measure and appraise performance against job duties, objectives and projects; assist in skills/career development; provide motivating work environment and accurate feedback on performance; recommend/approve merit increases, promotions, hires and terminations. Review and approval of timekeeping records and paid time off (PTO).
15. Assist with the development and implementation of company processes.
16. Oversee all Template Control departmental processes and policies. 
17. Represent Template Control in high level meetings regarding build plans for reagents and instrument support. 
18. Responsible for departmental merit and bonus, within company guidelines.
19. Responsible for ensuring all procedures/processes developed by or transferred into the Template Control department meet all validation requirements.
20. Responsible for all Template Control laboratory space including but not limited to ensuring lab areas are in compliance with environmental specifications, providing specifications and requirements for all new space planning, and development and execution of laboratory space move plans.
21. Demonstrates drive for professional excellence, creative problem solving, friendly and open collaboration, and independent thinking.

Supplemental Data

Position may require between 5-10% domestic and/or international travel to meet with external BioFire teams to support template manufacturing process development.

Qualifications

Training and Education

• Requires a BS degree (science or engineering major).  Appropriate college level classes and/or extensive experience in a related scientific field for the Engineering and/or Medical Device industry can substitute for a degree.
• Certifications in process improvement and/or project management are highly desired.
• Preference will be given to candidates that have experience with Quality Assurance and Manufacturing in an IVD setting.

Experience

• A minimum of 7 years of progressively more responsible directly related experience is required, including a minimum of 5 years of related experience managing a team.
• Experience must be both managerial as well as scientific.

Knowledge, Skills, and Abilities

• Demonstrate practiced managerial skills, including computer literacy in database, spreadsheet, project management, and word processing software.
• Master validation strategies as they pertain to the medical device manufacturing industry.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to write reports and manufacturing procedures.
• Ability to organize, lead, and objectively evaluate the work of other personnel.
• Structure time effectively, maintain exceptional organization, and efficiently manage matrixed team structures in alignment with department priorities
• Skilled in editing documents, reports, presentations, and manufacturing procedures.
• Effectively teach, train, and inculcate scientific principles, manufacturing best practices, and professional values.
• Demonstrate high-level business judgment and clear communication with cross-functional teams and others at all organizational levels
• Exceptional business etiquette, interpersonal skills, emotional intelligence, and aptitude for successful professional relationships

Physical Requirements

Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.