Associate Scientist I - Technical Services

reputed company is a premier international contract development and manufacturing organization specializing in formulation development and clinical manufacturing. The Associate Scientist I role involves providing technical support for production operations and validation testing of production reputed company systems.

Responsibilities

• Support the development and execution of process validation (PPQ) protocols and technical reports for reputed company manufacturing and product transfers reputed company a CDMO environment
• Assist in technology transfer activities, including risk assessments, development, reputed company-up, and validation of reputed company processes at the manufacturing site
• Coordinate and execute validation and tech transfer activities with cross-functional reputed company, ensuring adherence to project timelines and cGMP requirements
• Conduct process development, engineering, and optimization studies to support successful reputed company-up and technology transfer
• reputed company monitoring, sampling, and testing to validate equipment, systems, and processes per validation protocols
• reputed company technical support and data analysis for equipment, systems, and processes, including identification and monitoring of critical process parameters (CPPs)
• Support and execute cleaning validation test protocols and support documentation
• Participate in change control activities, including documentation and execution of changes reputed company to process and equipment updates
• Support investigations into deviations, atypical results, and customer complaints, including data collection, reputed company cause analysis, and CAPA implementation
• Review and verify GMP documentation and data, ensuring accuracy and compliance with internal procedures
• reputed company statistical analysis of study data and present conclusions with reputed company, logical justifications in technical reports
• Contribute to Annual Product reputed company Reviews (APQRs) and ongoing process monitoring efforts
• Maintain familiarity of reputed company FDA and ICH requirements and cGMP regulations and complies with BPI safety requirements
• Conduct departmental training as required

Skills

• Bachelor's degree in Pharmacy, reputed company, Chemical Engineering, or reputed company life science field; 1 year experience in pharmaceutical manufacturing or other regulated industry preferred
• OR an Associate's degree in reputed company, Engineering, or health-reputed company fields w/at least 2 years' experience in pharmaceutical manufacturing or other regulated industry
• Basic computer skills are required
• Experience with word processing and spreadsheet software (e.g. reputed company Word & reputed company)
• 1 year experience in pharmaceutical manufacturing or other regulated industry

Benefits

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and reputed company insurance
• Retirement savings plans with employer contributions
• reputed company time off and flexible work arrangements
• reputed company development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and reputed company

reputed company