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GCI Scientific Logistics and Assay Lifecycle Management Team Lead
Job in
Erie, Erie County, Pennsylvania, 16501, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Main Responsibilities:
- Collaborate with platform heads to optimize the assay lifecycle, streamline processes, and maintain quality control through performance monitoring.
- Strategically prioritize digital and equipment needs across GCI.
- Ensure timely and compliant closure of clinical assay investigations.
- Lead a team of transversal SLAs.
- Translate scientific requirements into operational strategies supporting organizational goals.
- Serve as main point of contact for GCI digital and FELS needs.
- Monitor equipment readiness and functionality.
- Lead documentation efforts to ensure compliance and process efficiency.
- Identify and implement process improvements and best practices.
Oversee scientific lab staff for transversal support; ensure versatile workforce through cross-training. - Yoh SOW owner and manage Yoh resources across LSI.
- Liaise with other platform leads and GI department heads/scientists to maintain end-to-end GI communication.
- Serve as function representative/SME at key meetings and with CROs and regulatory authorities.
- Act transversally to build and optimize novel bioanalytical methods for fast-moving projects within budget targets.
- Bachelor’s degree in life sciences (molecular, immunology, microbiology, virology, biochemistry or related) + 15+ years; or MS + 12+ years; or PhD + 8+ years.
- Proven operations management experience in biotech/pharma.
- Regulated laboratory experience as research scientist or laboratory manager (preferably pharma R&D).
- Experience developing new bioanalytical characterization methods for vaccines.
- Familiarity with bioanalytical/LBA instrumentation and techniques; strong immunogenicity assay knowledge.
- Understanding of GXP; experience in early and clinical stage development.
- Familiarity with clinical/sample databases and inventory management.
- Proven leadership in multi-functional/matrixed teams; quality systems experience in regulated environments.
- Expertise with LIMS, reagent characterization/qualification, equipment/supplies; familiarity with laboratory testing regulations.
- Strong project management; ability to work across diverse cultural backgrounds.
- Commitment to scientific excellence/innovation; excellent interpersonal skills.
- Leadership promoting cross-group collaboration; publication/patent/inventorship and conference presentation record.
- Proven experience managing personnel, budgets, and projects.
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