Scientist, Pharmaceutical Process Development

MSD • Rahway, NJ

6d • Hybrid

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.

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

Nice To Haves

• Minimum (3) years’ experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.)

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.
• 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.
• 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

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include 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.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees