Sample and Lab Coordinator (SLC)

Job Responsibilities:

• Receive, record, store, dispose, and ship biological samples in compliance with GxP and internal procedures for Biomarker/CDx, pharmacokinetic (PK), and ADA samples.
• Perform QC checks on shipment manifests and resolve discrepancies with stakeholders.
• Ensure laboratory areas are maintained, and equipment is qualified, calibrated, and in good working order.
• Manage laboratory consumables and inventory, maintaining accurate records.
• Contribute to continuous improvement initiatives and process optimization.
• Coordinate with clinical teams, research and development, bioanalytical/PK experts, and external partners for sample management.
• Oversee Central Lab activities and support audits and inspections.
• Maintain LIMS and central lab portals, assist with protocol reviews, and develop biospecimen documentation.

Skills:

• Proficiency in biospecimen management, laboratory coordination, and GxP compliance.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Expertise in LIMS (e.g., Watson LIMS) and bioanalytical methodologies.
• Advanced proficiency in Excel and digital solutions for data analysis.
• Organizational and project management skills.

Education/Experience:

• Bachelor’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
• Minimum 2 years of experience in biospecimen management and/or laboratory coordination in a regulated environment (GLP, GCLP, ICH-GCP).
• Proficiency in bioanalytical methodologies and regulatory requirements for drug development.
• Excellent communication skills, proficiency in English (written and spoken).
• Master’s degree in life sciences (Biology, Pharmacy, Veterinary, or related discipline).
• Experience with translational medicine operations and clinical trials.
• Knowledge of CDISC standards and controlled terminology.
• Experience in preclinical study support and laboratory operations management.