Scientist, Pharmaceutical Process Development

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

About the position

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).
This position has a multiple roles including
leveraging experience in drug product manufacturing to perform daily manufacturing operations (development & GMP) within the Formulation, Laboratory and Experimentation Center (FLEx Center)
supporting and/or leading pre-FLEx manufacturing activities that enable on-time program delivery
leveraging scientific/technical capabilities to support R&D development program activities as needed (formulation/process)
The Scientist position will flex between roles when necessary to drive program and development needs.

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.
Understand/act on guidance from supervisor where decisions are guided by policies, procedure and business plan
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

B.S. Degree in Science, Engineering or other related, technical field
Minimum (3) years’ experience in a functional area, such as Operations, Management, Quality, Technical Operations, Technology, Engineering
Accountability, Accountability, Bioanalytical Techniques, Biological Research, Chemical Engineering, Chemical Process Development, Clinical Investigations, Communication, Corrective Action Management, Detail-Oriented, Experimentation, Formulation Chemistry, GMP Compliance, Innovation, Inventory Management, Machine Learning (ML), Machine Troubleshooting, Manufacturing Processes, Manufacturing Quality Control, Packaging, Pharmaceutical Process Development, Pharmaceutical Systems, Policy Management, Process Optimization, Product Evaluations + 5 more