Senior Associate - Tech Transfers

Overview

Senior Associate responsible for tech transfers and validation activities for pharmaceutical development and production, including regulatory submissions and quality systems.

What you'll do

• Perform tech transfer process for new molecules and developmental studies exhibit batches.
• Handle process validation and regulatory submissions.
• Evaluate, review, and approve validation master plans, protocols, and reports.
• Troubleshoot validation issues for equipment and performance processes.
• Conduct statistical analysis of testing results and process anomalies for quality investigations.
• Write, review, and approve validation process documents and technical reports.
• Manage routine quality systems (change control, quality agreement, documentation, investigations) and coordinate testing with functional groups.

What you'll need

• High school diploma (or equivalent) with 8+ years of experience, or associate’s degree with 6+ years, or BA/BS with 2+ years, or MBA/MS with relevant experience.
• Experience in tech transfer process scale-ups, exhibit batches, and process validations.
• Knowledge of multi-market FDA regulations.
• Experience with Good Manufacturing Practices.
• Working knowledge of various quality systems and processes.
• Familiarity with Global Document Management System, System Application & Products, and Quality Tracking System.
• Excellent verbal and written communication skills.

Details

• Work location assignment: On Premise.