Syringe Filling PCU Lead

Scorpion Therapeutics; Pennsylvania; On-site; USD 130,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced operations leader to oversee the Line 7 Syringe Filling PCU for B57 aseptic filling at the Swiftwater site. You will provide direction across 24-hour operations, lead a 3-shift team of managers, and ensure safety, quality, and regulatory compliance.

Responsibilities include maintaining validated equipment, driving deviations, change controls, CAPAs, and regulatory commitments, and collaborating with QA and Maintenance to resolve issues in real time.

Qualifications

• Requires a High School Diploma and 7+ years in a cGMP aseptic manufacturing environment.
• 3+ years of experience leading teams.
• Preferred: Bachelor’s degree in Business/Engineering/Life Sciences with 3+ years aseptic experience and 1+ year leading teams.

Responsibilities

• Provide leadership, direction, and oversight of Line 7 Syringe Filling PCU for B57 Aseptic filling at the Swiftwater site with 24-hour coverage across shifts.
• Lead and develop a team of managers, supervising ~35–45 members over 3 shifts.
• Maintain facilities/equipment and ensure validated state of equipment and processes.
• Oversee Deviations, Change Controls, CAPAs, and regulatory commitments; lead audits.
• Ensure shop floor safety and quality; collaborate with QA and Maintenance to address issues in real time.
• Drive aseptic processing best practices to improve OEE and reduce costs; manage meetings and metrics.
• Support short-term projects, equipment/building integration, and day-to-day project needs.
• Set departmental objectives aligned to site vision; ensure associates have safe working conditions.

Skills

Leadership

People management

Regulatory knowledge

Quality systems

Education

Bachelor’s degree in Business/Engineering/Life Sciences

Tools

CAPA systems

MS Office

Job description

Main Responsibilities

• Provide leadership, direction, and oversight of Line 7 Syringe Filling Process Centric Unit (PCU) for B57 Aseptic filling at the Swiftwater site; ensure 24-hour performance across all shifts (safety, quality, supply, financial results).
• Lead and develop a team of managers; manage ~35–45 team members across 3 shifts.
• Ensure facilities/equipment are properly maintained and verify continued validated state of equipment and processes.
• Ensure timely, high-quality completion of Deviations, Change Controls, CAPAs, and regulatory commitments; meet FDA/International Regulatory Body/Corporate Quality requirements; lead operational audits.
• Ensure shop floor safety and quality; partner with QA and Maintenance to address issues in real time; build cross-functional relationships.
• Drive aseptic processing best practices and SMS 2.0 ways of working to improve Filling OEE, unit success rate, and reduce costs; guide Asset Care/CI/Deviation meetings and maintain required metrics/cycle times.
• Support special projects related to integration of buildings, equipment, and processes; provide day-to-day support for short-term projects.
• Set departmental objectives aligned to site vision (safety, quality, productivity, cost, continuous improvement, employee involvement); ensure associates have what they need to work safely.
• Resolve problems/introduce changes; set performance standards; evaluate and develop direct reports; provide career development, training, goals, and regular feedback.
• Manage headcount and departmental expenses to achieve site objectives and meet budget expectations.

Qualifications

• Minimum: High School Diploma + 7+ years in a cGMP aseptic manufacturing environment; 3+ years leading teams.
• Preferred: Bachelor’s degree (Business/Engineering/Life Sciences or related) + 3+ years cGMP aseptic experience and 1+ years leading teams.
• Strong understanding of quality systems; strong knowledge of cGMP and regulatory requirements; experience in controlled/pharmaceutical industry.

Preferred Qualifications/Skills

• Manage multiple production priorities while maintaining quality/compliance.
• Experience with external regulator inspections.
• Cross-functional experience (Quality, Manufacturing Excellence, MSAT, Facilities, Engineering, Validation).
• Review SOPs/on-the-job trainings and other controlled documents.
• Troubleshooting, investigations (GPS), root cause and risk analysis in cGMP.
• Ability to escalating operational issues appropriately.
• Leadership, communication, decision-making, conflict resolution, employee/team development.
• Business analysis, scheduling/planning, budget/headcount management, process improvement.

Special Working Conditions

• Ability to gown for entry to aseptic manufacturing areas.