Job Overview
We are seeking a skilled Technical Transfer Specialist to join our team. This individual will be responsible for coordinating technical activities related to commercial manufacturing processes at our Contract Manufacturing Organization (CMO) partner.
* The successful candidate will manage the development and execution of technical transfer projects, ensuring compliance with Good Manufacturing Practices (GMP) regulations and industry standards.
Technical Transfer Activities:
This role involves various tasks, including:
1. Preparing and reviewing GMP documentation, such as Master Batch Records, change control, protocols, reports, qualifications, etc.
2. Providing on-site support at External Partners during Commercial and/or Technology Transfer Person-In-Plant activities.
3. Translating GMP requirements and current regulations into actionable steps by partnering with Operations, Quality, and External Partners.
4. E nsuring that External Partners are inspection-ready for all routine inspections and/or inspections related to new product introductions or transfers.
Required Skills and Qualifications:
To succeed in this position, candidates should possess:
* A Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or other related science/engineering field.
* Minimum 4 years of post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
* Strong communication and teamwork skills.
* Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer.
* Demonstrated ability to independently manage projects/work to schedule/deadlines.
* Statistics experience, including Proactive Process Analysis and Continuous Process Verification.
* Experience in deviation management and/or change control and/or equipment support, and/or project management.
Travel and Work Environment:
This role requires approximately 25% travel time. The ideal candidate will thrive in a dynamic work environment, working closely with cross-functional teams to deliver high-quality results.