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

Apply for this Job

Summary

• Supervise day to day operation of the pharmaceutical 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 pharmaceutics, excipient compatibility, product development, and drug product process development.
• Key collaborations and partnerships include:
  • Research: Work with personnel to design and implement appropriate preformulation and development pharmaceutics studies; accept development candidates from research and study their characteristics; collaborate in drug delivery research efforts; assist in defining criteria for compounds to move forward in the Eyetech Development Model.
  • Marketing: Jointly define product characteristics appropriate for commercialization, including dosage form(s), primary and secondary packaging, label, and trademark.
  • Project Management: Provide and update timelines for activities within department; designate representatives to project teams.
  • Technical Operations: Develop drug product manufacturing processes suitable for transfer to a commercial venue. Provide support to manufacture of registration lots of drug product.
  • Clinical:Oversee manufacturing of clinical lots of drug product; order supplies to meet needs of clinical team.
  • Preclinical/Toxicology: Supply product for preclinical and toxicology studies if and when needed.
  • Analytical R&D;: Collaborate in the design and execution of stability studies for clinical drug product lots; execute studies to probe compatibility and routes of degradation. Conduct packaging development studies.
• Participate in the hiring and career development of scientists working in the department. Perform appraisals of their work.
• Attend conferences, symposia and meetings relevant to pharmaceutics, formulation, drug delivery, drug product manufacturing, the pharmaceutical industry, and the Eyetech franchise. Deliver presentations on work of the department both internally and externally as appropriate.
• Ensure that laboratory and clinical manufacturing areas operate in a consistent high level of cGMP compliance. Prepare and author SOPs, qualification documents, etc. and follow through to QA approval and issuance. Participate in FDA pre-approval and GMP 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 pharmaceutics and drug development 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, or equivalent.
• 8 to 10 years experience in the pharmaceutical industry. Experience in formulation and drug product process development, problem solving, drug development, and clinical supply manufacturing. 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 also be able to work on a variety of projects and serve a diverse customer base.
• 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, cGMP compliance necessary. Regulatory affairs knowledge needed.