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
Company Overview
Bora Pharmaceutical is one of the premier pharmaceutical companies in Taiwan. It was founded in 2007, and is headquartered in Taipei, T'ai-pei, TWN, with a workforce of 1001-5000 employees. Its website is http://www.bora-corp.com/.