Product Technical Operations Scientist

Description Product Technical Operations Scientist

Venesco LLC is seeking Product Technical Operations Scientists to provide Chemistry, Manufacturing and Controls (CMC), investigational product, manufacturing, quality, and nonclinical support across the medical product lifecycle to facilitate successful product development and regulatory approvals.

Requirements

Duties and Responsibilities

• 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.

Minimum 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.

Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are 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. For more information on Venesco, LLC., visit https://venesco.com.