Senior/Principal Scientist (FullTime)

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Summary

• Participate in the establishment of a core drug product formulations department with responsibility for the formulation, process, and drug delivery development activities required for regulatory approval.
• Provide technical leadership in the areas of aseptic filling, formulation component compatibility, stability, and process development and scale up of parenteral formulations in support of clinical studies and commercial product.
• Coordinate the activities of contract manufacturers associated with the preparation of drug product, as required. Some travel will be necessary (25%).
• 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 manufacturing through conferences and scientific literature.
• Advise management of applicable developments in the fields of drug product development/manufacturing as appropriate.
• Communicate/coordinate activities with Eyetech alliance partners. Travel and represent company when appropriate.

Qualifications

• BA/BS, MS, Ph.D. degree in chemistry, chemical engineering biochemistry, pharmacy or equivalent.
• 12+ (BS), 8+ (MS), 5+ (Ph.D.) years experience in pharmaceutical formulation and process development, preferably in biopharmaceutical parenterals.
• Proven track record of scientific/engineering accomplishments with a demonstrated ability to solve scientific/engineering 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.