Senior/Principal Scientist (FullTime)

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Summary

• Participate in the establishment of a core drug product formulations department with responsibility for the preformulation, formulation and drug delivery development activities required for regulatory approval.
• Independently design and conduct experiments, including review and analysis of experimental data, to assess physiochemical properties of new drug candidates and develop preliminary and final drug product formulations in support of clinical studies and commercial product.
• Prepare and maintain documentation including lab notebooks, scientific reports, summaries, protocols, and regulatory documentation in support of worldwide regulatory submissions.
• Supervise technical staff including day-to-day activities, personnel development and reviews.
• Keep current with field of drug product development, formulation and delivery through conferences and scientific literature.
• Advise management of applicable developments in the fields of drug product development/delivery as appropriate.
• Communicate/coordinate activities with Eyetech alliance partners and contract research organizations as necessary. Travel and represent company when appropriate.

Qualifications

• BA/BS, MS, Ph.D. degree in chemistry, biochemistry, pharmacy or equivalent.
• 12+ (BS), 8+ (MS), 5+ (Ph.D.) years experience in pharmaceutical preformulation/formulation development, preferably in biopharmaceutical parenterals.
• Proven track record of scientific accomplishments with a demonstrated ability to solve scientific problems.
• Demonstrated abilities to multi-task, work in a team-based environment and meet aggressive deadlines.
• Good oral and written communication skills required.
• Knowledge of drug development, cGMP compliance and regulatory guidances (ICH, FDA) necessary. Previous experience with IND/NDA filings a plus.