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.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.