Associate Scientist I - Technical Services

Job Overview Completes projects that provide general technical support for production operations and validation testing of production quality systems. This role requires to be onsite. Key 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 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 with current FDA and ICH requirements and cGMP regulations and comply with BPI safety requirements. Conduct departmental training as required. Qualifications Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related life science field with at least 1 year experience in pharmaceutical manufacturing or other regulated industry; or Associate’s degree in Chemistry, Engineering, or health‑related fields with at least 2 years’ experience in pharmaceutical manufacturing or other regulated industry. Basic computer skills in Microsoft Word and Excel; supplemental skills in PowerPoint and database software are beneficial. Strong understanding of cGMP, validation protocols, and statistical analysis. Compensation $60,000 - $80,000, based on qualifications, skills, and experience. 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 Equal Employment Opportunity Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. #J-18808-Ljbffr Bora Pharmaceuticals Inc