Senior Production Manager, Upstream

Overview :

The work we do at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. has never been more important and we are looking for talented candidates to join us.

We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

Join FDBU and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry.

We’re proud to cultivate a culture that will fuel your passion, energy, and drive what FDBU calls Genki.

The Senior Production Manager, Upstream is responsible for overseeing the Microbial and Cell Culture Upstream Manufacturing teams.

The individual in this role is responsible for delivery to the production schedule in a safe, compliant, and right the first time manner.

Drives a culture focused on compliance to cGMP requirements and supports deviation investigations and the implementation of corrective and preventative actions.

They initiate and oversee the implementation of new technology and modifications to existing technology aimed at cost reduction, efficiency improvements, minimization of downtime, and quality / safety enhancement.

Makes recommendations regarding departmental profit plan, capital planning, budget, and standards development. Recognizes and investigates opportunities for financial savings across a broad spectrum of operational activities.

Must be able to identify and communicate improvement opportunities and results. Identifies operational needs for special projects (new product sub-team, capital projects, etc.

ensuring site / divisional linkage is achieved. Mentors and trains managers and other new departmental employees.

Manage manufacturing production processes and systems by :

Proactively and regularly develops / manages team member’s performance and capabilities;

Assures team activities, equipment, facilities, and personnel are operated and maintained in a state of compliance with appropriate requirements and manages coordinators responsible for change-over activities.

• Measure and report schedule adherence delivery on a production schedule;
• Develops, measures, and improves strategies within the team that are in alignment with site and operational strategies;

Drives profit plan targets to ensure alignment with profit plan targets.

All other assigned duties as deemed necessary.

External US :

MAJOR ACTIVITIES AND RESPONSIBILITIES :

Employee Development & People Management :

• Coaches managers and coordinator(s) in a learning culture with the goal of achieving employee empowerment and ownership;
• Assists the manager with the development of objectives and ensures alignment with site and department goals;

Provides ongoing formal and informal feedback to direct reports; including 1 : 1’s

Assesses employee training / development needs, assesses the maturity of the team, and adjusts leadership style to enhance team performance;

Recognizes and addresses direct report performance

Responsible for preparing and presenting process trends and present results for active processes for real-time process monitoring.

Maintain budgeted headcount while assessing and providing input for increase as processing requires

Production Performance Ownership :

Manufacturing point of contact for internal and external program teams

Be the primary contact for production managers on shift to escalate issues or events

Observes critical operations, with production managers

Responsible for coordinating tasks and events with other cross-functional support groups (maintenance, process sciences, MTS, QC, and others)

Leads, coordinates, and implements manufacturing process and compliance improvements

Manages, tracks, and reports adherence to metrics, design standards, and performance

Responsible for ensuring audit readiness of their area

Approves and authors documents including but not limited too : protocols, work instructions, and SOPs

Ensure continuous improvement of standard work and other visual management tools used by Manufacturing for operations

Information Transfer :

Partners with readiness coordinators and process sciences to ensure manufacturing technology transfer success and right-first-time execution.

Participate and lead in PPA, PA and FEMA, stage gate, and client events, to ensure manufacturing readiness success;

Serves as liaison between shifts, teams, and other departments and interacts with clients, in select project meetings.

Attends / provides input at departmental, team, and cross-functional meetings, including equipment / process improvement

Cross-departmental communication to ensure process and operational success

Ensure good communication and understanding between managers to include other mfg. areas to maximize efficiency between US and DS i.

e resources, process timelines, etc.

Compliance :

Leads and / or participates in critical investigations for atypical, observation, and process capability investigations

Oversight of compliance metrics and work with Quality Management to establish priorities and improve systems

Reviews safety investigations and safety and environmental program compliance for manufacturing

Participates in internal and external audits and inspections, to include leading facility and area tours

Identifies quality-related trends and is responsible for on on-time completion of compliance-related actions

Periodic GEMBA critical operations to ensure deviation-free / right-first-time performance and build skills with technicians

BACKGROUND REQUIREMENTS :

B.S. / B.A. degree preferred (science, engineering, or other technical field preferred), but not required, plus 2 years of coaching / supervisory experience and a minimum of 7 years experience in a related Bio Pharm field.

Demonstrated leadership, interpersonal, technical aptitude, and problem-solving skills.

Strong team skills, including the ability to coach / develop work teams, provide training, motivate / empower others, and resolve conflict.

Must be flexible and able to manage multiple priorities

Excellent verbal and written communication skills

Must be available as needed to support a 4 shift, 24 hour / 7 day a week organization; requiring availability on nights, weekends and potentially holidays.

Physical Demands :

Essential physical requirements, such as climbing, standing, stooping or typing.

Physical effort / lifting up to 50 lbs.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.

S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 130 and Export Administration Regulations in 15 C.

F.R. Part 730 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.

S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.

S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed, please e-mail (url removed)

To all agencies : Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email, the internet or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.