Scientist-Biopharmaceutics & Pharmacokinetics


Job ID 17-00253

Industry Pharma

Job Type Permanent

Location Denville, NJ

Description

Job Responsibilities
The selected candidate should be able to perform the following in the areas listed below:
1. Clinical/ Bioequivalence studies
a. Technical/ scientific review of study protocols and recommendations based on scientific principles
b. Review and finalization of BE study reports as per regulatory requirements
c. Performing IVIVC and recommendations to the formulation development team
d. Coordination with CROs for scheduling/completing the studies as per timelines
2. Biostatistics
a. Verification of statistical data output from CROs
b. Treatment of data for statistical output under various simulated scenarios
c. Assisting the FR&D groups in Design of Experiments (DoE) planning and interpretation
Justification for the position This position will be a resource available to the organization in getting the coordination work done with various CROs in conducting the clinical/ bioequivalence studies, review of the BE reports and providing the same to regulatory for filing to the Agency in timely manner.
In addition, this position will add significant contribution to the formulation development groups, both in US and in India,
1. in creating the design space for the robust formulation and process through appropriate application of DOE (design of expts) concepts and
2. in assessing the formulation data of the ongoing projects and providing the direction to the FR&D groups in choosing the right dissolution conditions to get better assurance of bioequivalence study success.



Qualifications

Qualifications MS or Ph.D in Pharmaceutical Sciences from a reputed Institute with special emphasis on Biopharmaceutics and Pharmaco-kinetics
Experience
1. 3-5 years in a Pharmaceutical company in the area of bioequivalence (BE)/ clinical studies
2. Should be able to use the statistical packages like SAS, DoE and interpret the data and results
Should be conversant with
1. Deep understanding of drug ADME concepts
2. Basic statistics and its application in IVIVC, Bioequivalence calculations
3. Basic understanding of dosage form development
4. FDA regulatory guidance relevant to clinical/ bioavailability/ bioequivalence studies
5. Literature and patent search capabilities for the drug products undergoing clinical/ bioequivalence studies