Job Title: Vial Process Manager
Location: Swiftwater, PA

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.

This role manages all shift-level processes to meet departmental goals and priorities while ensuring full compliance with regulatory authorities including cGMPs, CBER, WHO, EP, and other applicable regulatory bodies.

Key responsibilities include planning and initiating production schedules, coordinating personnel activities across manufacturing teams, and reviewing batch records for accuracy and completeness. The role carries broad accountability across employee development, counseling, cost reduction recommendations, quality assurance, incident investigations, CAPAs, and departmental budget management. Shift flexibility is required to drive project completion.

The position serves as the primary managerial coverage for shift employees and acts as a key liaison for communicating technical issues and process improvements to relevant stakeholders (e.g., IOC, Management Committee, staff meetings). When required, this role coordinates Maintenance, Metrology, and Validation activities with functional leaders and plays an active role in implementing new equipment and procedures.

Deviation management, people development, and Quality Assurance of the Aseptic Processing area are core to this role. A background in Aseptic Processing is strongly preferred.

Main Responsibilities

Main Responsibilities

• Production Management - Lead and schedule shift operations using eOOE, iObeya, Qualipso, SAP, and Ocularis
• Critical Function Leadership - Execute 5W2H analyses, Gembas, MSVs, LSVs, real-time reviews, BFRs, and audits
• Process Improvement & Projects - Identify and lead continuous improvement initiatives that enhance performance and reduce waste
• Cross-Functional Coordination - Partner with departments to align priorities and achieve +QDCI standards
• PCU Development & Training - Support team growth through coaching and training
• Personal Development - Pursue professional growth through assigned training and certifications

Key Accountabilities

Safety: Enforce safety procedures, conduct LSVs/MSVs, report incidents, participate in walkthroughs and investigations

Quality: Ensure cGMP compliance, lead 5W2H/deviation meetings, develop CAPA, conduct real-time reviews, maintain Quality relationships

Delivery: Analyze data to drive performance improvements, support production flexibility, follow escalation procedures, review eOOE metrics, ensure timely training

Cost: Drive CI and cost reduction initiatives, minimize deviations, improve operator efficiency, support changeover functions

Involvement: Complete training modules, maintain qualified trainer status, train new team members, lead 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
• Working knowledge of cGMPs is required
• Experience with aseptic processing is strongly preferred

Skills & Competencies

• Highly detail-oriented and organized with strong time-management capabilities
• Strong analytical and problem-solving skills with the ability to adapt in a dynamic environment
• Excellent verbal and written communication, interpersonal, and presentation skills
• Ability to interact effectively with employees at all levels of the organization
• Intermediate proficiency in MS Office Suite
• Working knowledge of SAP (preferred)
• Familiarity with Lean Manufacturing principles (preferred)
• Mechanical and engineering competency (preferred)
• Engineering background (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

Pursue Progress. Discover Extraordinary.

The salary range for this position is:
$78.000,00 - $112.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.