This role is for a scientist who is an individual contributor with operational and technical responsibilities in Animal Health Pharmaceutical Sciences & Clinical Supplies (R&D).
Requirements
- Support internal (FLEx Center; commercial sites) and external (CMOs) transfer of manufacturing processes.
- Link to project teams/meetings to drive pre-FLEx manufacturing deliverables.
- Support in preparation and manufacture of development and GMP drug product batches
- Oversee inventory management and ensure raw materials are ordered and available for manufacturing activities
- Lead data management activities related to communication through FLEx Scheduling and virtual tools.
- Initiate deviation, change control, and documentation requests to comply with our company Quality Standards
- Incorporate scientific and technical knowledge to complete assigned tasks.
- Collaborate with internal stakeholders to drive effective communication and completion of deliverables.
- Understand priorities from manager/supervisor to ensure task completion.
- Identify and help to resolve standard day to day quality, technical, and operational problems.
- Trouble-shooting manufacturing process failures. Set priorities to meet daily deadlines
- Work within budgetary/financial objectives.
- Make decisions guided by policies and standard operating procedures.
- Compliance: Responsible for creating and sustaining a culture of compliance (Safety, Environment, cGMP).
- Responsible for driving continuous improvement and reviewing compliance documents, as per procedures
- Exercise judgement and decision making to ensure quality product is reliably produced.
- Continuous Improvement: Tie into overall FLEx Center metrics across modalities to drive efficiency.
- Utilization of our company's Leadership Behaviors and Inclusion to promote daily work activities.
- Keep informed on current policies/procedures and all other FLEx Center communications.
- Enforce all safety rules and regulations and take prompt corrective action concerning potential safety hazards.
- Identify root causes of manufacturing issues and implement corrective action
- Enhance operational and/or technical capability through project experience or outside learning.
- Author/review documentation related to operational procedures and/or reports
Benefits
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
