Sr. Mgr, Biopharmaceutics

Overview

Alvogen Pine Brook, Inc. seeks a qualified candidate for Sr. Mgr, Biopharmaceutics at its Pine Brook, NJ facility. The Sr. Mgr, Biopharmaceutics will conduct bioequivalence (BE) studies and/or clinical end-point studies sponsored by Alvogen, ensuring that data are documented and reported in compliance with the study protocol; ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), the Declaration of Helsinki, and all applicable regulatory requirements in the country where the study is conducted.

The Sr. Manager, Biopharmaceutics will design comparative research studies for human participants to test potential treatment options for Alvogen pharmaceutical innovator and generic products; conduct and monitor BE studies; ensure that the application of these studies meets regulatory requirements; ensure clinical supplies are shipped to clinic sites for BE studies; ensure in-house SOPs and applicable guidance documents are followed during administration of BE and human comparative studies;

oversee and manage the Clinical Research Associate.

• Conduct bioequivalence studies and/or clinical end-point studies sponsored by Alvogen, ensuring data are documented and reported per the study protocol and in compliance with GCP, GLP, the Declaration of Helsinki, and applicable regulatory requirements.
• Design and oversee comparative research studies for human participants to test treatment options for Alvogen products (innovator and generic).
• Conduct and monitor BE studies and ensure regulatory compliance of study applications.
• Manage the shipment of clinical supplies to clinic sites for BE studies.
• Ensure in-house SOPs and guidance documents are followed during BE and human comparative studies.
• Oversee and manage the Clinical Research Associate.

• MS degree in Pharmacy, Biopharmaceutics, or related Life Sciences, plus 3 years of pharmaceutical/biopharmaceutical industry experience. A BS in Pharmacy or Biopharmaceutics plus 5 years of progressive post-baccalaureate experience substitutes for the Master’s degree and 3 years of related experience.
• Experience in managing laboratory staff and participants in human research studies.
• Excellent written, verbal communication, and interpersonal skills.
• Detail-oriented and structured, a team player, able to prioritize and work within timelines, with good communication skills.

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