Our Client is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, and to aid in biomedical research. They are also a leader in development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women.
- Responsible for the support of launched/approved products and operations processes and the creation and transfer of manufacturing processes from R&D to Manufacturing and site to site transfers of on-market products.
- Responsible for the development of LEAN processes by the removal of waste and continuous improvement of existing process.
- Responsible for the development of new processes, transfer to manufacturing and continuous improvement of existing processes.
- Provide process support to Manufacturing and other Operations Groups.
- Responsible for Pilot & Development Manufacturing activities, Scale-Up of production processes as the production demand dictates.
- Provides the support needed to complete Process Validation activities and training of manufacturing staff during the validation cycle.
- Directs Subordinates to complete assignments using established guidelines, procedures and policies. Monitors daily operations of the Process Transfer Department.
ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES
- Ensures team actions and deliverables are completed to the required due dates and project timelines.
- Works collaboratively to problem solve with other departments.
- Performs document review and approvals for the department.
- Operates effective performance management of the Process Transfer team setting appropriate and business aligned goals, reviewing against expectations.
- Provides guidance and development opportunities for team members.
- Develops validation strategies for projects and agrees with the responsible member of Quality Engineering.
- Contributes to department budget creation and ensures that department expenditure is within or below expectations.
- Assigns and determines the team workload and priorities.
- Oversees the development inventory locations and development production activities
- Produces notebook, development, pilot and production materials
- Oversees ERP real time transactions.
- Reviews and independently generates notebook studies, technical reports, development and manufacturing documents.
- Oversees and executes process validation of new and existing manufacturing processes
- Represents Process Transfer on one or more core teams.
- Provides the main point of contact and participates on behalf of Process Transfer in FDA and ISO lab audits.
- Assists with troubleshooting experimentation required for projects.
- Troubleshoots complex manufacturing process problems.
- Oversees the development of manufacturing processes for transfer to Manufacturing.
- Trains Manufacturing Operators on newly developed procedures.
- Support the Technical Writers by contributing to manufacturing work instructions, area guidelines, knowledge base topics, style guides/templates, & department SOPs.
- Reports periodically to management on project progress and status.
- Provides technical support to Operations groups
- Responsible for the Engagement plan and execution for the Process Transfer team.
- Drive Value Improvement Project initiative for the team.
- Typically requires BA or BS and experience desired
- Working knowledge of experimental design.
- Advanced knowledge of current GMPs.
- Blood Borne Pathogen training.
- Interpersonal skills
- Technical skills
- Work under own initiative and uses own judgment
- Works collaboratively
- Builds working relationships
- Problem Solving
- Proficiency with MS Word and Excel.
- Strong math skills.
- Applied knowledge of Technical writing.
- Experience with presentation skills.