Associate Scientist I - Technical Services
Bora Pharmaceuticals 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 quality systems.
Responsibilities
- Support the development and execution of process validation (PPQ) protocols and technical reports for commercial manufacturing and product transfers within a CDMO environment
- Assist in technology transfer activities, including risk assessments, development, scale-up, and validation of client processes at the manufacturing site
- Coordinate and execute validation and tech transfer activities with cross-functional groups, ensuring adherence to project timelines and cGMP requirements
- Conduct process development, engineering, and optimization studies to support successful scale-up and technology transfer
- Perform monitoring, sampling, and testing to validate equipment, systems, and processes per validation protocols
- Provide 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 related to process and equipment updates
- Support investigations into deviations, atypical results, and customer complaints, including data collection, root cause analysis, and CAPA implementation
- Review and verify GMP documentation and data, ensuring accuracy and compliance with internal procedures
- Perform statistical analysis of study data and present conclusions with clear, logical justifications in technical reports
- Contribute to Annual Product Quality Reviews (APQRs) and ongoing process monitoring efforts
- Maintain familiarity of current FDA and ICH requirements and cGMP regulations and complies with BPI safety requirements
- Conduct departmental training as required
Skills
- Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related life science field; 1 year experience in pharmaceutical manufacturing or other regulated industry preferred
- OR an Associate's degree in Chemistry, Engineering, or health-related 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. Microsoft Word & Excel)
- 1 year experience in pharmaceutical manufacturing or other regulated industry
Benefits
- Competitive salary and performance-based incentives
- Comprehensive health coverage including medical, dental, and vision insurance
- Retirement savings plans with employer contributions
- Paid time off and flexible work arrangements
- Professional development opportunities
- Employee wellness programs and resources
- Employee Assistance Program and Mental Health Resources
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