Sr. API Technical Operations Manager (Remote Contractor - Organic Chemist)
This multinational pharmaceutical and biotechnology corporation is a leading producer of therapeutics, with 50,000+ employees and revenues exceeding 10 billion annually. The company has expanded its Irish footprint to include significant manufacturing operations and key global roles responsible for its contract manufactured product portfolio.
The Position
* Transfer APIs from internal sites to Contract Manufacturing Organizations (CMOs), ensuring comparable physical and chemical quality for customers.
* Qualify identified markets and meet business milestones and drivers by coordinating action plans and timelines.
* Proactively identify and communicate project/plan issues, and implement corresponding resolutions.
* Lead Global Tech Transfer Teams, including API sites, CMOs, and other stakeholders, providing technical support and guidance.
* Lead ES API source change activity and qualification of alternate CMO suppliers, developing project implementation plans and chairing meetings.
* Investigate problems during transfer and scale-up processes, and recommend solutions.
* Analyze transferring API processes, comparing CMO proposals, and writing/reviewing process-related documents.
* Lead quality issue investigations at CMO sites, addressing chemistry, processing, or analytics-related product quality concerns.
* Communicate effectively with team members and colleagues to ensure clear and precise communication within the Project Team.
* Manage process validation activities, project management requirements, and finished goods specifications.
* Collaborate with multifunctional teams to resolve Technical Transfer-related problems and manage Cost Improvement Projects.
* Provide Subject Matter Expert (SME) input to improve product performance in quality and cost, and engage with contract manufacturers to ensure successful project delivery.
The Person
* Bachelor's degree in Chemistry, Chemical Engineering, or related scientific discipline; advanced degree preferred.
* Broad knowledge of technology transfer process and manufacturing for active pharmaceutical ingredients.
* Good technical understanding of pharmaceutical processes and the impact of technical change.
* Demonstrated experience and competence in organizing, planning, and problem-solving related to qualifying new API suppliers.