PK Assay Specialist
Where
- Groton, CT
What you'll be doing
- Responsible for the scientific integrity of concentration data to support clinical programs and provision of bio analytical expertise to assigned projects (e.g by way of representation on clinical study teams). Coordinate with routine biomarker sample, bio analyses and ensure timely availability of quality and routine bio marker concentration data in support of clinical studies. Selection and qualification of external CROs for PK and ADA assays. Oversight of clinical PK, immunogenicity and routine bio marker assays run internally and at external CROs. Act as point of contact for Clinical Assay Group for those externals CROs. Method development and validation of new assays and transfer and validation of developed assay methods to external CROs. Lead troubleshooting the methods when this technology transfer encounters difficulties. Coordinate pharmacokinetic, immunogenicity and routine bio marker sample bio analyses in support of clinical studies including retrieval of final data. Ensure that optimal timelines are set and met. Evaluate and review raw data and study analytical reports and assay validation reports, as appropriate, to insure laboratories are performing analysis in compliance with current regulatory and Industry standards and that data are of the required quality (regulatory and scientific). Periodically inspect external CROs performing assays that support programs. Make effective contributions to the day to day operation of the CAG. May represent group on company initiative sub teams. Assists in writing regulatory submissions and responds to regulatory queries when needed. Ability to produce and present quality scientific papers at external meetings and for publication. Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bio analysis to ensure that company bio analytical practices are consistent with regulatory expectations. Ability to provide guidance to colleagues regarding development and validation of LBA and cell based assay methods. Ability to act as a mentor for training purposes. Understanding of the scientific /regulatory standards for method validation, quality control etc with regard to the generation of bio analytical data.
What your background should be
- Previous pharmaceutical experience and/or experience outsourcing bio analysis or working in a large molecule bio analytical laboratory under GLP, GCP, and in clinical trial settings. Previous experience assessing immunogenicity of large molecule biotherapeutics. A detailed knowledge of a wide range of bioanalytical techniques with an emphasis on ligand binding based assays (e.g. ELISA, MSD, Gyros) and cell based bioassays. Demonstration of extensive experience in problem solving LBA and cell based assays and analytical skills. Thorough up to date knowledge of large molecule analytical methods, technologies and their application.
Required Schooling / Training
- MS degree in biological sciences/analytical chemistry.
Who is the client company
- The company provides pharmaceutical service.
- If you are interested in this position, send your resume to apply@kochdavis.com
