Senior Executive / Assistant Manager - IVIVC

AET Laboratories

5 - 10 years

9 - 17 Lacs

Hyderabad

Posted:4 days ago| Platform:

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Skills Required

IVIVC Invivo In Vitro In Vivo Correlation In Vitro

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Responsibilities :

Develop and validate
IVIVC and PBPK models
to predict in vivo drug performance from in vitro data.
Conduct
in vitro experiments
such as solubility, dissolution, and permeability studies using biorelevant media.
Collaborate with formulation, analytical, and clinical teams to optimize drug product development.
Analyze
bioequivalence (BE) study data
and support regulatory submissions with modeling insights.
Prepare and review
technical reports, protocols, and regulatory documentation
.

Preferred candidate profile & Qualifications:

Should be well versed with IVIVC concepts,preferably 5-10 years of experience.
Should have excellent knowledge on product development and clinical studies.
Should have hands on experience on operating various simulation tools necessary for IVIVC.
Excellent communication skills are must.
Strong knowledge of
oral solid dosage forms (OSDs)
and excipient functionality.
Experience with
regulatory guidelines
(e.g., USFDA, EMA) related to IVIVC and BE studies.
M.Pharm or Ph.D. in Pharmaceutics, Biopharmaceutics, or Pharmaceutical Sciences.

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