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.
Management of Key Interfaces:
- 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.
Basic Requirements:
- Bachelorβs 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.
Preferred Requirements:
- 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.