Vial Filling Process Manager (2nd Shift)

About the role

The Vial Process Manager is responsible for overseeing all personnel and operational activities within their assigned shift, ensuring full team adherence to +QDCI standards. This role drives continuous improvement of line performance by leading and supporting strategic projects and initiatives, including thorough investigation of deviations from planned outcomes and the development of robust Corrective and Preventive Actions (CAPA) to prevent recurrence. The position requires strong leadership, people managing skills, shift flexibility for coverage and project completion, regulatory awareness, and a commitment to producing safe, high-quality aseptic products.

Key responsibilities

• Planning and initiating production schedules
• Cross-functional coordination to align priorities and achieve +QDCI standards
• Supporting team growth through coaching and training
• Completing training modules, maintaining qualified trainer status, training new team members, and leading meetings professionally

Physical Working Conditions

Office environment and proper PPE >50% of time; isopropyl alcohol exposure

About you

• Education: Bachelor's degree in Life Sciences, Engineering, or a related field with relevant manufacturing/filling experience and 3+ years of experience in manufacturing and/or development within a pharmaceutical environment OR 7+ years of relevant experience in manufacturing and/or filling of biological products
• Experience: 3+ years of experience in manufacturing and/or development within a pharmaceutical environment, prior experience in an FDA-regulated industry is required
• Skills & Competencies: Working knowledge of cGMPs is required, experience with aseptic processing is strongly preferred

Key competencies

• Operational Excellence: Drives consistent, high-quality production outcomes through disciplined planning and execution
• Technical Expertise: Applies deep knowledge of aseptic manufacturing to solve complex process challenges
• People Leadership: Inspires, develops, and empowers teams to achieve their full potential
• Regulatory Acumen: Ensures full compliance with applicable regulations and internal quality standards
• Continuous Improvement: Proactively identifies opportunities to improve processes, systems, and outcomes
• Cross-Functional Collaboration: Builds strong partnerships across departments to achieve shared goals
• Data-Driven Decision Making: Leverages production data and digital tools to inform priorities and actions
• Patient Safety Focus: Maintains an unwavering commitment to product quality and patient safety in all decisions