What does a Bio-pharmaceutical Scientists do? : Pharmaceutical Career Guide
Role of Bio-pharmaceutical Scientists:
The pharmacokinetics of a drug depends on patient-related factors as well as on the drug’s chemical properties. Some patient-related factors (eg, renal function, genetic makeup, sex, age) can be used to predict the pharmacokinetic parameters in populations. Bio-pharmaceutical Scientists help prescribers adjust dosage more accurately and rapidly. The application of pharmacokinetic principles to individualize pharmacotherapy is termed therapeutic drug monitoring.
Biopharmaceutical Scientist's Job Specifications:
Skills of Bio-pharmaceutical Scientists:
Expertise in Pharmacokinetics / Bio-pharmaceutics or related field in academic research or generic pharmaceutical company or contract research organization
Hands-on experience in independently designing pharmacokinetic studies for ANDAs (and possibly NDA submissions), reviewing bio-analytical protocols/reports, analyzing pharmacokinetic data, and proposing PK strategies from a quality-by-design (QbD) perspective.
Demonstrated ability to work independently, manage and prioritize multiple projects, and perform concertedly in a team environment.
Exhibits a sense of urgency, ownership, and drive. Demonstrates excellent interpersonal, written, and verbal communication skills, and ability to prepare written reports/correspondence and presentations to senior leadership.
Ability to work closely with Product Development scientists by performing as one of the technical leads in bio-pharmaceutics. The incumbent will also act as an advisor in clinical drug development, CRO outsourcing, study monitoring, project management, and ensure that study conduct is in compliance with regulatory requirements.
Awareness of FDA and other guidelines on clinical studies and their conduct.
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