Job Summary: We are seeking a highly skilled and detail-oriented Process Development Scientist to support technical transfer, process validation, and sustaining operations for pharmaceutical or biotech manufacturing processes. The successful candidate will play a key role in ensuring seamless product transfer, maintaining operational excellence, and driving continuous improvement.
Key Responsibilities:
- Tech Transfer and Sustaining Operations:
- Collaborate with cross-functional teams to facilitate product transfer and establish robust processes.
- Ensure post-process performance qualification (PPQ) process sustainability and resolve issues as needed.
- Change Control:
- Evaluate and implement change control strategies to ensure process alignment with regulatory requirements.
- Assess potential risks and document changes meticulously.
- Technical Documentation:
- Develop comprehensive technical assessments, protocols, and reports.
- Author clear and concise commissioning, qualification, and validation (CQV) reports.
- Data Analysis and Statistical Evaluation:
- Perform statistical analysis to evaluate process performance and capability.
- Leverage data to identify trends and propose improvements.
- Process Validation:
- Lead process validation activities in alignment with industry standards.
- Document validation outcomes and analyze results for accuracy.
- Visual Inspection:
- Conduct visual inspection of filled syringes to ensure quality standards.
- Support MSAT visual inspection requirements during manufacturing processes.
Qualifications:
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- Proven experience in technical transfer, CQV, and process validation within the pharmaceutical or biotech industry.
- Strong expertise in data analysis, statistical methods, and change control.
- Familiarity with regulatory requirements (e.g., FDA, EMA) and Good Manufacturing Practices (GMP).
- Exceptional attention to detail, problem-solving abilities, and communication skills.
Preferred Qualifications:
- Experience with visual inspection techniques for injectable products.
- Knowledge of post-PPQ process sustainability practices.
Why Join Us: Be part of a dynamic team dedicated to delivering high-quality products and innovative solutions in pharmaceutical manufacturing. Your expertise will contribute directly to improving patient outcomes worldwide.