Manufacturing Lead

Overview

The Manufacturing Lead will oversee and perform cGMP manufacturing operations for manufactured biopharmaceutical products.

Ensure the effective use of material, equipment, and personnel while making products at high quality levels. Recognized as a subject matter expert with regard to manufacturing processes.

The schedule for this position is 7 p.m. to 7 a.m.

External US

The Manufacturing Lead will oversee and perform cGMP manufacturing operations for manufactured biopharmaceutical products.

Ensure the effective use of material, equipment, and personnel while making products at high quality levels. Recognized as a subject matter expert with regard to manufacturing processes.

Oversee manufacturing production team by :

• 1) Proactively and regularly develops / manages team member’s performance and capabilities;
• 2) Assures team activities, equipment, facilities, and personnel are operated and maintained in a state of compliance with appropriate requirements;
• 3) Assures delivery upon production supply schedule;

4) All other assign duties as deemed necessary

MAJOR ACTIVITIES AND RESPONSIBILITIES :

EMPLOYEE DEVELOPMENT / PEOPLE MANAGEMENT

• Mentors technicians in an employee involvement culture with the goal of achieving employee empowerment
• Assists the team with 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

PRODUCTION PERFORMANCE

• Troubleshoots equipment problems, identifies need for new equipment and / or modifications to existing equipment to optimize throughput;
• Ensures equipment is maintained in a qualified state;
• Maintains and continuously improves standard work shift plan and visual management tools for the team
• Observes all critical operations to ensure deviation free / right first time performance and build skill with technicians
• Proactively looks 2-3 days out at process and schedule to ensures equipment, materials, and supplies are available for upcoming operations

INFORMATION TRANSFER

• Attends departmental and team meetings focused on equipment / process improvement;
• Serves as liaison between shifts, teams and other departments

COMPLIANCE

• Ensures GMP documents are completed accurately and timely
• Ensures completion of real time documentation of observations or execution events. Initiates any necessary investigations.
• Initiates safety incidents and supports corrective and preventative actions
• Initiates real time deviations
• Supports internal and external audits and inspections
• Identifies out of expectation process trends and escalates appropriately
• Ensures compliance training is completed and technicians are qualified to perform tasks
• Ensures the execution and closure of SFO’s in Pas-X prior to records being removed from the floor
• Ensures room inspections are completed and update assignment list as needed

BACKGROUND REQUIREMENTS :

B.S. / B.A. degree preferred (science, engineering or other technical field preferred) plus a minimum of one year experience in a related technical field.

Required : High School Diploma or equivalent with a minimum of 5 years’ experience in a related technical field.

Demonstrated leadership, interpersonal, technical aptitude, and problem solving skills. Strong team skills, including ability to coach / develop work teams, provide training, motivate / empower others, and resolve conflict.

Must be flexible and able to manage multiple priorities. Must be goal-oriented and able to manage risks. Good verbal and written communication skills.

It is expected that employees in each grade have the ability to perform all tasks of lower level positions in areas or responsibility.

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,