Alvogen Pine Brook, Inc. seeks a qualified candidate as Sr. Mgr, Biopharmaceutics @ its Pine Brook, NJ facility. The Sr. Mgr, Biopharmaceutics will conduct bioequivalence(BE) studies &/or clinical end-point studies sponsored by Alvogen, & ensure that generated data is documented & reported in compliance w/ the study protocol; ensure that Good Clinical Practice(GCP), Good Laboratory Practice(GLP), the Declaration of Helsinki,& all applicable regulatory requirements are complied with in the country where the study is to be conducted.
The Sr. Manager, Biopharmaceutics will also design comparative research studies for human participants to test potential available treatment options for Alvogen pharmaceutical innovator & generic products; conduct & monitor bioequivalence studies,& ensure that application of these studies meet all regulatory rqmts; ensure that clinical supplies are shipped to clinic sites for bioequivalence studies; ensure that in-house SOPs and applicable guidance documents are followed during administration of bioequivalence & human comparative studies; oversee& manage the Clinical Research Associate.
Min. rqmts. for this position are:
- MS degree in Pharmacy, Biopharmaceutics, or related Life Sciences degree plus 3-years exp. in the pharmaceutical/biopharmaceutical industry. BS in Pharmacy or Biopharmaceutics plus 5-yrs of progressive post-baccalaureate degree experience in the pharmaceutical industry will substitute for a Master’s degree in Pharmacy & 3-yrs of such experience.
- Experience in managing laboratory staff & participants in human research studies.
- Excellent written, verbal communication, & interpersonal skills.
- Detail-oriented and structured, team-player, able to prioritize & work within timelines, good communication skills
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