Sr. Scientist, Engineering

MSD

4d•$117,000 - $184,200•Hybrid

About The Position

The Chemical Commercialization Technology (CCT) department, which is part of our Manufacturing Division, is seeking a self-motivated individual who is looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work. The Senior Scientist, Engineering position leverages scientific/technical experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline. The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).

Requirements

The position requires a BS and/or MS with a minimum of 5 years relevant work experience or PhD in Chemical Engineering from an accredited college/university
Relevant work experience in chemical process development, including the following:
Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity
Highly effective communication and collaboration skills
Good organizational, interpersonal, writing, and time management skills
Ability to operate within a cross-functional process development team
Accountability
Adaptability
cGMP Regulations
Chemical Engineering
Chemical Manufacturing
Chemical Technology
Chromatographic Techniques
Detail-Oriented
Deviation Investigations
Good Manufacturing Practices (GMP)
Innovation
Manufacturing Processes
Process Design
Process Optimization
Process Scale Up
Quality Risk Assessment
Risk Assessments
Self Motivation
Small Molecule Synthesis
Strategic Planning

Nice To Haves

Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization
Experience leading regulatory file authoring, validation planning and execution
Experience guiding internal/external technical discussions
Familiarity with statistical design and analysis tools
Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory
Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting
Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles.

Responsibilities

Develop safe and robust manufacturing processes through process characterization.
Technology transfer.
Validation.
Filing and supply support of late-stage projects in the small molecule pipeline.
Provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments.
Hands-on experimentation at the laboratory bench and kilo lab scales.
Technology transfer to commercial manufacturing facilities.
Following current Good Manufacturing Practices (cGMPs).
Participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).