Executive Development Specialist

6 days ago

Vadodara, Gujarat, India beBeeDevelopment Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Overview

We are seeking an Executive Development Specialist to join our team. In this role, you will be responsible for designing and conducting experiments for preformulation and formulation optimization of microsphere and long-acting complex non-oral dosage forms, implants, in-situ gels, etc., based on the Quality by Design (QbD) approach.

Responsibilities
  • Design and conduct experiments as per the design of experiments
  • Execute literature searches, prepare summary reports, and reviews for ANDA projects
  • Prepare product development study protocols and reports as per regulatory requirements
  • Enter experimental details, observations, and test requests in eLNB METIS software
  • Compile and interpret experimental trials and stability study results using MINITAB software
  • Prepare technology transfer documents like Master Files (MF), Risk Assessments based on Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs)
  • Prepare justification for import materials, documents for Form 29 applications, and Common Pharmaceutical Documents for DCGI submissions
  • Execute scale-up exhibits at plants and prepare scale-up summary reports
  • Prepare stability protocols as per regulatory requirements
  • Prepare Product Development Reports, Risk Assessment Reports for Elemental Impurities, Residual Solvents, and Extractables for regulatory submissions
  • Prepare pre-ANDA meeting packages, scientific justifications, and/or reports for various regulatory agencies
  • Prepare SOPs related to laboratory equipment and instruments
Requirements

To be successful in this role, you should have a strong background in pharmaceutical sciences, experience with QbD approaches, and proficiency in laboratory equipment and software. Additionally, you should be able to work independently and as part of a team, communicate effectively, and demonstrate a collaborative spirit.

What We Offer

We provide a comprehensive benefits package, opportunities for professional growth and development, and a supportive work environment. If you are a motivated and detail-oriented individual looking for a challenging role, please apply now.

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