Senior Director/Director, Bioanalytical Research & Development (FullTime)

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Summary

• Supervise day to day operation of the bioanalytical R& D laboratory. Plan/design experiments, assign work to scientists and manage the workload of the laboratory. Provide scientific guidance to staff.
• Direct all efforts and activities in the areas of bioanalytical and toxicology analysis.
• Key collaborations and partnerships include:
  • Research: Work with personnel to design and implement appropriate analytical methods for preliminary animal studies to define development candidates; accept development candidates from research and study their bioanalytical characteristics; help make decisions on choosing candidates based on appropriate metabolic data and models.
  • Preclinical/Toxicology:Obtain input as to design of preclinical studies to allow development and validation of sensitive and selective methods for drug and metabolites in biological fluids.
  • Clinical/Clinical Pharmacology: Coordinate analysis of clinical samples with contract laboratory organizations. Troubleshoot and solve problems with methods of analysis.
  • Project Management: Provide and update timelines for activities within department; designate representatives to project teams.
  • Analytical R&D;: Communicate with regard to design of appropriate methods, capital/analytical equipment/capabilities. Balance outsourcing versus in-house technical capabilities.
• Attend conferences, symposia and meetings relevant to pharmaceutics, drug metabolism, bioanalytical chemistry, the pharmaceutical industry, and the Eyetech franchise. Deliver presentations on work of the department both internally and externally as appropriate.
• Participate in the hiring and career development of scientists working in the department. Perform appraisals of their work.
• Ensure that laboratory and clinical manufacturing areas operate in a consistent high level of GLP compliance. Prepare and author SOPs, qualification documents, etc. and follow through to QA approval and issuance. Participate in internal and external audits and inspections.
• Prepare and review scientific reports and regulatory documentation for inclusion in worldwide regulatory submission.
• Prepare/manage operating and capital budgets for department.
• Keep current with field of biopharmaceutics and analysis through conferences and reading of scientific literature.
• Communicate with Eyetech alliance partners and contract research organizations. Travel and represent company when appropriate.

Qualifications

• Ph.D. in chemistry, pharmacy, pharmacology, or equivalent.
• 8 to 10 years experience in the pharmaceutical industry. Experience in drug metabolism, clinical and/or preclinical pharmacology, problem solving, and drug development. Direct experience with biologics preferable.
• Proven track record of scientific accomplishment. Demonstrated ability to solve scientific problems and face regulatory challenges necessary.
• Ability to multi-task and handle an abundance of customers; need to be flexible.
• Supervisory skills, ability to work in a team environment, and meet aggressive deadlines mandatory.
• Good oral and written communication skills desired.
• Knowledge of drug development, GLP procedures necessary. Regulatory affairs knowledge needed. cGMP compliance knowledge a plus.