Sterile Production Supervisor (Onsite)

MSD • Rahway, NJ

2d • 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 primary accountability 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) and safety. The role involves tactical and strategic shift management, including collaboration with indirect staff, and promoting 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.
• Ability to develop and lead others
• Ability to be flexible and understand risk
• Continuous improvement
• Conflict resolution
• Leadership style – adaptive; high performance coaching; servant leader
• Compliance mindset to safety, environmental, and quality regulations
• 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.
• Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives.
• Identifies and resolves standard day-to-day quality, technical, and operational problems within own unit.
• Makes decisions – guided by policies and standard operating procedures – that impact the efficiency and effectiveness of own unit.
• Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business.
• Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement.
• Responsible to review and approve compliance documents, as per procedures or need.
• Exercises judgment and decision making to ensure quality product is reliably produced while managing cost.
• Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).
• Accountable for developing a company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s).
• Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans.
• Report Shift(s) monthly metrics and any action plans to address gaps to Management.
• Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability and eliminate waste.
• Responsible for creating and sustaining a highly engaged workforce through utilization of our company's Leadership Behaviors and Inclusion.
• Provide coaching on professional development and career paths.
• Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation.
• Provide feedback and input on performance evaluations for indirect staff.
• Support Talent Management.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level