Vial Filling Process Manager (2nd Shift)

Scorpion Therapeutics; Pennsylvania; On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking a capable shift leader to oversee manufacturing operations, ensuring adherence to +QDCI standards and safety requirements in a GMP environment. This role emphasizes hands-on supervision, data-driven decision making, and continuous improvement to meet production goals.

You will coordinate cross-functional teams, drive CAPAs, coach and train personnel, and leverage SAP, Ocularis, and related tools to optimize performance and reduce waste across the line.

Qualifications

• 3+ years in pharmaceutical manufacturing/development.
• FDA-regulated industry experience required.
• Aseptic processing experience strongly preferred.

Responsibilities

• Oversee shift personnel to ensure +QDCI standards.
• Lead shift operations using eOOE, iObeya, Qualipso, SAP, and Ocularis.
• Execute analyses and reviews (5W2H, Gembas, MSVs, LSVs) and audits.
• Investigate deviations and develop CAPAs.
• Identify and lead continuous improvement projects.
• Coordinate cross-functionally to align priorities.

Skills

Detail-oriented

Time management

Analytical thinking

Education

Bachelor’s degree in Life Sciences/Engineering

Tools

eOOE

iObeya

Qualipso

SAP

Ocularis

Job description

Main Responsibilities

• Oversee shift personnel and operations to ensure adherence to +QDCI standards.
• Lead and schedule shift operations using eOOE, iObeya, Qualipso, SAP, and Ocularis.
• Execute critical analyses and reviews (5W2H, Gembas, MSVs, LSVs), real-time reviews, BFRs, and audits.
• Investigate deviations from planned outcomes and develop robust Corrective and Preventive Actions (CAPA).
• Identify and lead continuous improvement projects to enhance performance and reduce waste.
• Coordinate cross-functionally to align priorities and achieve +QDCI standards.
• Support PCU development through coaching, training, and professional growth activities.

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 CAPAs; conduct real-time reviews.
• Delivery: Use data to drive performance improvements; support production flexibility; follow escalation procedures; review eOOE metrics; ensure timely training.
• Cost: Drive CI and cost reduction; minimize deviations; improve operator efficiency; support changeover functions.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field with relevant manufacturing/filling experience and 3+ years in pharmaceutical manufacturing/development.OR 7+ years relevant experience in manufacturing/filling biological products.
• 3+ years experience in pharmaceutical manufacturing/development.
• Prior FDA-regulated industry experience (required) and working knowledge of cGMPs (required).
• Aseptic processing experience strongly preferred.

Skills/Competencies

• Detail-oriented; strong time management; strong analytical/problem-solving.
• Excellent communication and interpersonal skills; ability to work with all organizational levels.
• Intermediate MS Office; SAP knowledge preferred; Lean principles and mechanical/engineering competency preferred.