Lead, Technical Transfer

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.
• Proficient project management skills.
• Ability to collaborate with and coordinate cross-functional teams.
• Proficiency with Microsoft Suite applications (Word, Excel).
• High attention to detail.
• Able to multi-task and manage responsibilities within ongoing projects.