Sterile Production Supervisor (Onsite)

Merck•Rahway, NJ

4d•$117,000 - $184,200•Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations. This is a first-line operations supervisor role with a team of individual contributor production direct reports. The goal is to ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP), safety, etc. This role involves tactical and strategic shift management, including collaboration with indirect staff, and promoting the behaviors and principles that drive continuous improvement.

Requirements

Minimum (4) years’ experience in a functional area, such as operations Management, Quality, Technical Operations, Technology, Engineering or Maintenance.
Bachelor’s Degree in Business Administration, Science, Engineering or another technical field, or at least 7 years experience in pharmaceutical manufacturing or processing with HS diploma.
Aseptic Processing
Leadership
Sterile Filling
Sterile Manufacturing
Sterile Operations
Sterile Processing
Sterile Products

Nice To Haves

Minimum (2) years’ experience in aseptic/sterile drug product manufacturing or processing
Minimum (2) years’ experience in heavily regulated industry (e.g. FDA, military, nuclear and petro-chemical)
Minimum (2) years’ direct supervisory experience.
Demonstrated knowledge of Lean
Demonstrated experience of interacting with site, divisional or regulatory audits
Continuous Improvement
Manufacturing
Manufacturing Operations

Responsibilities

Coordinates and supervises the daily activities of individual contributors, setting priorities for the team to ensure task completion and coordinating work activities with other supervisors.
Identifies and resolves standard day-to-day quality, technical, and operational problems within own unit, making decisions guided by policies and standard operating procedures that impact the efficiency and effectiveness of own unit.
Works within budgetary/financial objectives set by the Director.
Ensures compliance with safety, environmental, and cGMP regulations, establishing a 'Right First Time' culture by reducing waste and driving continuous improvement. Reviews and approves compliance documents.
Ensures quality product is reliably produced while managing cost, and is responsible for shift supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).
Develops a company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develops strategic initiatives related to the manufacturing process, equipment, and human resources. Reports Shift(s) monthly metrics and action plans to Management. Identifies, prioritizes, and champions improvement initiatives.
Creates and sustains a highly engaged workforce through utilization of company's Leadership Behaviors and Inclusion. Provides coaching on professional development and career paths, timely feedback, and performance evaluations for direct reports. Provides feedback and input on performance evaluations for indirect staff and supports Talent Management.