Duties and Responsibilities:
* Oversee technical activities for commercial manufacturing processes at the Contract Manufacturing Organization (CMO) Partner, encompassing authorship of change control documents, management of process improvement projects, and analysis of process performance.
* Pursue technical transfer activities, as necessary, through authorship and/or review of required Good Manufacturing Practice (GMP) documentation, including Master Batch Records, change control documents, protocols, reports, qualifications, and regulatory filings.
* Provide on-site support at External Partners to facilitate Commercial and/or Technology Transfer Person-In-Plant Activities.
* Translate understanding of GMP requirements and current regulations into standardized work procedures by collaborating with Operations, Quality, and External Partners.
* Ensure that External Partners are adequately prepared for all routine inspections and/or inspections related to new product introductions or transfers in conjunction with Operations, Quality, and Regulatory teams.
Requirements:
* Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or a related science or engineering field.
* Must have a minimum of 4 years of experience in Drug Substance Technical Transfer, preferably in a leadership role.
* Minimum of 4 years post-bachelor's degree experience in a GMP functional area or supporting a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
* Frequent travel is a requirement of this position, estimated at approximately 25%.
* Excellent 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 and meet deadlines.
* Experience in statistics, including Proactive Process Analysis and Continuous Process Verification.
* Background in deviation management, change control, equipment support, and/or project management.