3 to 5 years technical experience in pharmaceutical manufacturing
Bachelor's, master's or ph.d. degree in technical field
Knowledge of cgmp guidelines and quality by design principles
The role involves supporting or leading new product introductions by conducting process comparisons and developing clinical supply manufacturing strategies
Job Summary
The role involves supporting or leading new product introductions by conducting process comparisons and developing clinical supply manufacturing strategies.
Candidates must demonstrate strong technical writing skills for change requests, PPQ reports, and CMC sections while ensuring compliance with regulatory requirements.
The position requires active participation in Continued Process Verification, Annual Product Review, and troubleshooting production system issues to ensure robust manufacturing.
Matching Summary
The role involves supporting or leading new product introductions by conducting process comparisons and developing clinical supply manufacturing strategies.
Skills & Requirements
Must-have
3 to 5 years technical experience in pharmaceutical manufacturing
Bachelor's, Master's or Ph.D. degree in technical field
Knowledge of cGMP Guidelines and Quality by Design principles
Experience with process optimization and sterile manufacturing
Ability to author PPQ protocols and regulatory documentation
Nice-to-have
Strong adaptability and personal initiative
Collaboration across global company S&T network
Leadership behaviors aligned with company standards
Experience with Production Systems tools for improvement
Proactive safety walks and Process Safety Management participation
Key Requirements
Bachelors, Masters or Ph.D. degree in Chemical/Mechanical Engineering, Chemistry, Biological sciences or Pharmaceutical Sciences
3 to 5 years technical experience in pharmaceutical manufacturing industry