Senior Principal Scientist, Bioanalytical Outsourcing
Overview
You will own the outsourcing strategy for bioanalytical assays across GLP and clinical-stage programs, managing external CRO partners from initiation through reporting. You will oversee drug quantitation, immunogenicity, and soluble target engagement on platforms like LC-MS/MS and ligand binding assays. You will coordinate with internal teams and ensure contractual obligations are met, including timelines, cost, and quality. This role includes supporting programs in China and requires domestic and international travel up to 20%. You will drive scientific assessments of external labs to maintain BDDS standards.
What You'll Do10
- 1Oversee all bioanalytical assays at external partners, including drug quantitation and immunogenicity (ADA and NAb), ensuring seamless execution from initiation to reporting.
- 2Coordinate review of supply agreements, protocols, and reports, ensuring compliance with GLP and regulatory requirements.
- 3Monitor deliverables, timelines, cost, and quality against contracts, and submit work orders and change orders through internal systems.
- 4Lead regular meetings with CRO labs to discuss progress, resources, and issues, communicating updates to J&J partners.
- 5Review data from CRO labs daily or weekly, troubleshoot issues, and implement resolutions to meet reporting and submission deadlines.
- 6Prepare Data Transfer Agreements and coordinate sample tracking and shipping schedules with central labs.
- 7Verify sample shipments and receipts, ensuring accuracy and timeliness for each analytical effort.
- 8Track and review data reporting files from CROs for formatting and content accuracy.
- 9Prepare shipping permits for study reagents to support programs in China, ensuring compliance with HGRAO guidelines.
- 10Conduct onsite business reviews and scientific assessments of external CROs, evaluating capabilities against BDDS standards.
Requirements10
- 1PhD with 6+ years post-doctoral experience or Bachelor’s degree with 12+ years of working experience.
- 2Knowledge of drug development from discovery to BLA/NDA license application.
- 3Hands-on experience with ligand binding assays including immunogenicity assays.
- 4Hands-on experience with LC-MS/MS assays for small and large molecule therapeutics.
- 5Experience managing bioanalysis for clinical trials and GLP preclinical studies.
- 6Proven problem-solving, organizational, and interpersonal skills.
- 7Ability to work under timelines and collaborate within multidisciplinary teams.
- 8Travel required up to 20%, domestic and international.
- 9Preferred: familiarity with Good Laboratory Practices, Good Clinical Practices, and global regulatory guidance for bioanalytical method validation and immunogenicity assays.
- 10Preferred: excellent record keeping and communication skills.
Salary Insight
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