Product Technical Operations Scientist

Requirements

• Support manufacturing strategy development.
• Review product specifications and manufacturing records.
• Support investigational product accountability and logistics.
• Review analytical and bioanalytical validation activities.
• Participate in manufacturing audits and inspections.
• Review stability programs and quality documentation.
• Support CMC content for regulatory submissions.
• Evaluate manufacturing risks and quality deviations.
• Support nonclinical study review activities.
• Participate in integrated product teams.

Qualifications

• Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field.
• Minimum 5 years of CMC or pharmaceutical development experience.
• Knowledge of FDA regulatory requirements, GMP, and GLP.
• Experience supporting regulated product development.

Skills

• Strong understanding of chemistry, manufacturing, and controls (CMC).
• Experience with investigational products and manufacturing logistics.
• Knowledge of regulatory submission processes and quality documentation.
• Ability to conduct and participate in manufacturing audits and inspections.
• Experience with stability programs and quality risk management.
• Proficiency in nonclinical study review and integrated product team participation.

Benefits

• Venesco, LLC, is an equal opportunity and affirmative action employer.
• The company is dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
• Visit https://venesco.com for more information about Venesco, LLC.

Pay

$135,000 - 150,000