Senior Director – Bioanalytical

Genesis Biotechnology Group is a consortium of vertically integrated companies, with a mission of improving patient’s care through cross linking our expertise, dedication, and vision in the fields of drug discovery, personalized and tailored clinical diagnostics, and through the development, manufacturing and distribution of unique biotechnology-based products.   Job Summary: Function as the scientific lead for small molecule and peptide pharmacokinetics and pharmacodynamics.  Drive business and growth within the bioanalytical laboratory group through oversight, leadership, and training.  Duties including but not limited to:  study design, costing/pricing of studies, client engagement and management, training of staff, method development, assay validation, sample analysis, PK/PD analysis, and reporting.   Responsibilities:   Serve as the lead contact with clients and prospects; interacting directly with clients and prospective clients on bioanalytical study design, costing/pricing, study quoting, and method development. Perform the responsibilities of Study Director with respect to bioanalytical validations and qualifications for regulated and discovery bioanalytical studies. Assist business development in attracting and cultivating client relationships.  The successful incumbent will have experience developing and implementing assays for small molecules, peptides, and metabolites in multiple tissue matrices in a GLP environment.  Must have excellent laboratory bench skills, experience with multiple HPLC-MS/MS platforms, and good interpersonal skills. Mentor and develop staff. Generating quotes and study protocols as well as provide oversight and assistance with writing and review of final study reports. Building additional services for the bioanalytical center of excellence. Interfacing with multiple groups for the successful implementation, conduct, and interpretation of studies.    Job Requirements:   Demonstrable expertise in current Bioanalytical techniques, instrumentation, and the overall drug development process. A scientific degree (B.S., M.S., and Ph.D.) with relevant CRO industry experience, 3 years preferred. Experience in a client-facing role w/ the ability to lead initial discussions on proposed bioanalytical requests for quotations and/or proposals. Proficient with Microsoft Office, Analyst, Xcalibur software. Experience with PK analysis using Phoenix WinNonlin is preferred. Experience with oversite of regulated studies including FDA GLP, GMP and GCP requirements and guidance.  Ability and experience developing and implementing bioanalytical extraction and instrumentation assays. Experienced with Sciex and Thermo LC-MS platforms is preferred.  Excellent written, presentation and verbal communication skills.