Scientist, Pharmaceutical Process Development
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.
Responsibilities
• 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
Requirements
• 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
Nice-to-haves
• Minimum (3) years’ experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.)
Benefits
• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
Apply Now
Apply Now
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.
Responsibilities
• 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
Requirements
• 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
Nice-to-haves
• Minimum (3) years’ experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.)
Benefits
• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
Apply Now
Apply Now