Vaccine Manufacturing Manager Production Influenza Bulk Drug Substance Upstream 2nd Shift

Main Responsibilities

• Manage multiple priorities independently or as part of a team to meet key deadlines.
• Communicate issues and progress across all levels of the organization.
• Resolve QA shop floor observations promptly to maintain product quality.
• Perform monthly HSE audits, complete HSE investigations, and provide support for HSE Corrective and Preventive Actions (CAPAs).
• Perform GEMBA Walks to ensure strict adherence to quality and compliance in our facilities.
• Support Deviation closures to ensure compliance and continuous improvement.
• Support CAPAs, Change Controls, internal audits and any other regulatory commitments.
• Execute Batch Record Sections and Final Review in a timely manner in order to hit production targets.
• Manage +QDCI L1 boards to meet company KPIs and drive change.
• Establish performance expectations and evaluate direct reports.
• Manage employee development goals to foster growth and skill.
• Support a culture of teamwork.
• Drive efficient communication between employees through shift change huddles.
• Manage personnel attendance using Labor Utilization Role-Based Schedule Tool, ADP, Workday.
• Actively involved in onboarding new hires to ensure smooth integration.
• Monitor Metasys/Lab watch applications to ensure GMP status of the production floor.
• Serve as an escalation point and make decisions to resolve issues promptly.
• Responsible for project work on the shop floor, providing assistance and recommendations regarding processes or equipment.
• All other duties as assigned.

About You

Basic Qualifications

• Bachelor's degree with a minimum of 5 years of experience in Quality, Production, manufacturing operations or other related fields.
• Associates degree with a minimum of 7 years of experience in Quality, Production, manufacturing operations or other related fields.
• High School degree with a minimum of 10 years of experience in Quality, Production, manufacturing operations or other related fields.

Skills:

• Experience with managing, supervising or leading teams.
• Experience in Viral manufacturing and/or Bacterial Manufacturing.
• Excellent communication and interpersonal skills.
• The ability to work on cross functional project teams.
• Demonstrated ability to meet/exceed timelines/deliverables.
• Continuous improvement techniques and problem solving/analytical skills.
• Ability to negotiate/influence.
• Organized and detail oriented.

Special Working Conditions

• Ability to lift to 50 lbs.
• Ability to stand on average 8 hours per shift.
• Ability to gown and gain entry to manufacturing areas.
• Ability to work a twelve-hour rotating shift and every other weekend, including holidays as scheduled.
• May require personnel to flex into another platform within MTech and/or another M&S department, as well as the possibility to work weekends, holidays or off shift hours based on business need.
• May also include working in an aseptic processing area.