SUMMARY OF POSITION
Biopharmaceutics is a department within Alvogen. This position is responsible for management of bioequivalence studies conducted to support ANDAs. This position will be responsible to ensure studies are conducted as per GCP, GLP and regulatory guidelines.
This position reports to the Vice President, Biopharmaceutics.
Responsible for the management of bioequivalence studies including, analysis of subject recruitment, review and finalization of trial related documentation (protocols, case report forms, informed consent forms, and review of reports) and management of clinical supplies.
Design BE studies according to current standards and guidance applicable. Ensure adherence to GCP and GLP
Monitoring the assigned study following company SOPs and in accordance with GCP + GLP. Management of AEs and SAEs following company SOPs and in accordance with regulatory
Maintain trial master files
Participate as a team member in project meetings Knowledge of bioanalytical and PK/Stats is a plus
BS or MS degree in relevant scientific discipline with at least 5 yrs of pharmaceutical industry experience in biologicals research and development and or Ph.D in Pharmaceutical Sciences with 4 years of relevant industry experience.
10 years of experience in Biopharmaceutics, BA/BE studies, FDA requirements, GCP and GLP.
Thorough knowledge and understanding of scientific principles applicable to development and implementation Excellent written and verbal communications and interpersonal skills Ability to travel internationally and extended stays
Personal attributes: Detail-oriented and structured, team-player, able to prioritize and work within timelines, good communication skills.
GMP DECISION-MAKING AUTHORITY
No GMP Decision-Making Authority
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