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KCAS is looking for a Senior Director of Large Molecule Services

KCAS Bioanalytical & Biomarker Services is seeking a Sr. Director of Large Molecule Services. This position will be responsible for leading and developing a technical operations group responsible for production activities involved in delivering regulated data and reports under GLP requirements to clients. Leads the organization to implement vision and executes tactical operations through assigned staff.  The Director will be required to ensure quality and compliance are maintained, and to be able to effectively communicate.

Critical Functions 

  • Responsible for all activities related to method development, method validation, and sample analysis of PK, ADA, PD, and Biomarker assays for support of pre-clinical and clinical trials.
  • Acquire and introduce appropriate new technologies to the Large Molecule operation, to diversify operational capability, and/or improve quality and/or efficiency.
  • Act as an expert resource in development, optimization and troubleshooting of LBA methods; provide troubleshooting guidance to resolve complex bionalytical problems.
  • When needed, interact with QA to answer analytical procedure questions and provide rationale.
  • Comply with applicable regulatory expectations, and keep abreast of industry trends in GLP.
  • Effectively interface with various functional units, groups or departments in the company.
  • Effectively interact with external clients and business development team.
  • Hire competent staff and build a strong scientific and operational team.
  • Assure that continuous training and educational needs of the staff are met in a timely manner. 


Education / Experience Requirements

  • PhD with 10 years preferred or equivalent experience in developing a wide variety of Ligand-binding based analytical techniques in regulatory compliant environment, directing scientific and technical personnel, interactions with regulatory agencies.

Comprehensive knowledge of

  • Working knowledge of GLP compliance as related to large molecule bioanalytical laboratory.
  • Scientific expertise in Ligand-binding assay development, validation and implementation.
  • Strong and effective people management and interpersonal skills.
  • Demonstrated leadership skills to provide direction to people working in multi-tasking and quality sensitive environment.
  • Knowledge and experience with use of radioactive materials and radiation safety procedures.
  • Strong communication skills, both written and spoken.

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