Title: Senior Manager, Translational Medicine Sample Logistics
Reports to: Associate Director, Immuno-Oncology Bioanalytical
Location: Camarillo, California
Classification: Exempt
Overview:The Senior Manager, Translational Medicine Sample Logistics will play an important role in reconciling and maintaining an active inventory of biomarker/bioanalytical samples for Coherus clinical trials. The successful team member will support translational/bioanalytical scientists with vendor management, including scheduling of analysis, shipment of samples, and ensuring timely data transfer to Coherus. The individual will join a dynamic and multidisciplinary team focused on the advancement of new drug candidates for the Coherus Oncology pipeline.
Responsibilities:
- Partner with translational medicine and clinical teams to manage PK, ADA, biomarker sample workflows, including collection schedules, shipment logistics, vendor analysis timelines, and query resolution.
- Manage end-to-end sample operations for clinical and non-clinical studies, including sample tracking, reconciliation, inventory oversight, long-term storage and issue resolution.
- Support development and execution of clinical sample management plans in collaboration with clinical, translational medicine, bioanalytical, data management, and central laboratory teams.
- Coordinate sample shipments, analysis schedules, and data transfers with internal stakeholders, central labs, and third-party assay vendors.
- Assist with reconciliation and data cleaning activities to ensure sample records are accurate, complete, and aligned with study timelines and deliverables.
- Review study protocols, lab manuals, kit specifications, informed consent forms, and related study documents for sample collection, processing, storage, and shipment requirements.
- Support audit readiness by maintaining sample documentation and participating in quality assurance or study audit activities as needed.
- Work closely with external vendors and central laboratories to resolve sample discrepancies, shipment issues, accessioning questions, and data transfer challenges.
- Contribute to process improvements and standardization of sample management procedures, reporting practices, and vendor communication pathways.
Qualifications:- BS in life sciences with 10+ years of biotech/ pharmaceutical industry experience.
- Demonstrated ability to multi-task with a high level of attention to detail to support biospecimen operations.
- Prior direct experience with biological sample management.
- Prior process development experience is very desirable.
- Familiarity with databases is desirable.
- A strong understanding of GCP/ICH is desirable.
- Experience working in cross-functional teams and developing effective cross-functional relationships.
- Ability to be proactive and flexible with changing work priorities.
- Ability to navigate ambiguity and take the initiative to create and define structure.
- Excellent analytical, logical thinking, and problem-solving skills.
- Excellent verbal, written, and presentation skills.
- Ability to successfully motivate individuals to complete projects in a timely manner.
- Ability to work in a small company and a fast-paced environment.
The Base Salary Range for this position is $140,000 to $175,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
