Lead, Technical Transfer

The Position

This position will be primarily responsible for leading technical transfer activities to support manufacturing readiness. This includes writing and developing GMP batch records, methods, and other necessary documentation to ensure effective process transfer between process development and manufacturing groups. They will assist with writing and updating SOPs and technical documents pertaining to GMP operations. The position is also responsible for coordinating process transfer activities for new and existing programs across cross-functional teams.

Responsibilities

• Work between process development and manufacturing scientists to create and maintain production batch records and process documentation for new and existing programs.
• Facilitate cross-functional coordination and input to document new methods
• Manage project timelines and provide project milestone updates to internal team members
• Identify and implement best practices and process improvements to technical transfer activities and documentation
• Lead deviation investigations and implement appropriate corrective action as necessary.
• Contribute to the compilation of master data
• Write SOPs pertaining to GMP production.
• Perform reviews of executed batch records
• Work with different departments to achieve project readiness goals
• Occasionally assist with laboratory work as needed

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• 3 years working in a GMP setting with a minimum of 1 year of experience in a technical writer or technical transfer position
• Proficient experience working with controlled documentation
• Experience with internal CAPA investigations
• Proficient project management skills
• Ability to collaborate with and coordinate cross-functional teams
• Proficiency with Microsoft Suite applications (Word, Excel)
• High attention to detail
• Ability to multi-task and manage responsibilities within ongoing projects

Preferred

• 5+ year's GMP experience and 3+ years tech transfer experience.