Job Title:
Operational Lead
Key Responsibilities:
* Serve as primary production process owner responsible for New Production Introduction, lifecycle management projects, and/or CAPEX projects, and established process improvements projects.
* Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling, and Inspection.
* Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
* Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
* Support scheduling and execution of Characterisation, Engineering, and PPQ runs.
Requirements:
* Bachelor's degree in a science discipline.
* 3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Desirable Skills:
* Strong Project Management and organizational skills.
* Critical thinking skills: gathers data from key stakeholders, analyses, and interprets information to develop solutions to technical problems of moderate complexity.
* Negotiation and Influencing skills.
* Take initiative to identify and drive improvements.
* Excellent verbal and written communication skills.
* Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area.
* Teamwork and Coaching others.
* Demonstrated ability to work independently and deliver right first-time results under minimal direction.