Biosample Operations Senior Associate / Manager

Who We Are

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description

Calico is seeking a Biosample Operations Senior Associate / Manager to manage the lifecycle of clinical samples, from patient to data. This position will be responsible for managing biosample collection, processing, shipment, tracking, storage, and analysis while ensuring compliance with clinical protocols, regulatory requirements and ethical standards. The ideal candidate will work closely with cross-functional teams including Clinical Operations, Data Management, Biomarker Scientists, Biostatistics, and external vendors.

Responsibilities

• Coordinate biosample logistics from clinical sites to central labs and analysis laboratories
• Manage query resolution and documentation
• Contribute to development of biosample management plans (BMPs), study protocols, ICFs, lab manuals and other relevant study documents
• Collaborate with Biomarker and Clinical teams to ensure sample and data delivery and support data analysis and interpretation
• Assist with process improvement activities for biosample operations including development of vLIMS and biomarker data management systems to ensure traceability and accurate documentation
• Participate in study team meetings and provide updates on sample operational status
• Ensure compliance with clinical trial protocols, regulatory guidelines, and Good Clinical Practice (GCP)
  
  

Position Requirements

• Bachelor’s degree in a life sciences discipline or related field
• Minimum of 5 years’ experience in laboratory setting or sample management within the biotechnology or pharmaceutical industry
• Demonstrated understanding of ICH, GCP, and GLP guidelines
• Excellent organizational, interpersonal, and communication skills
• Strong proficiency with electronic data management systems (LIMS) and sample tracking software
• Proficiency with Microsoft Office, advanced Microsoft Excel skills preferred
• Demonstrated ability to establish priorities, work independently and collaborate effectively with the cross-functional team and external partners/vendors
• Must be willing to work onsite at least four days a week
  
  

Nice To Have

• Previous oncology drug development experience
• Prior experience building LIMS system
  
  

The estimated base salary range for this role is $100,000 - $144,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.