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: 

1. Review summary basis of approval, prescribing information, and other relevant literature on specific marketed products in order to prepare detailed summary reports in support of pharmacokinetic (PK) studies.

2. Design PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical, and specialized dosage forms, including parenteral, ophthalmics, otic, nasal sprays, metered-dose inhalers, and transdermal patches
3. Develop, review, and recommend scientifically-supported PK study BE protocols for ANDAs (and some NDA products)
4. Review bio-analytical method validation protocols and reports from CROs and ensure compliance with compendial and other regulatory requirements
5. Establish in-vitro in-vivo correlations by convoluting/deconvoluting PK data, using WinNonLin® or other equivalent applications.

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.

How much does a Bio-pharmaceutical Pharmaceutical Scientist make?

As of  2022, The average annual pay for a  Bio-pharmaceutical Pharmaceutical Scientist in the United States is $85,530 a year. Just in case you need a simple salary calculator, that works out to be approximately $41.12 an hour. This is the equivalent of $1,645/week or $7,128/month based on the data of ZipRecruiter 

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