Scientist, Engineering Full-time

Scientist, Engineering

The Chemical Commercialization Technology (CCT) department, which is part of our company's Manufacturing Division, is seeking self-motivated individuals who are looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work.

The Scientist, Engineering position leverages scientific/technical experience to develop safe and robust processes through process characterization, tech transfer, validation, filing and supply support. The incumbent is expected to provide scientific expertise in small molecule active pharmaceutical ingredients (API) process characterization work by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on wet chemistry experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. Approximately 10-20% travel time is expected. 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).

Position Qualifications

Education Minimum Requirement:

• The position requires a BS with 2 years of experience or MS in Chemical Engineering (or related engineering field) from an accredited college/university

Position Requirements / Required Experience and Skills:

• Strong understanding of chemistry and/or chemical engineering fundamental concepts
• Desire to learn and engage in process scale-up and technology transfer, moving from laboratory to pilot plant or factory scale
• Desire to perform both laboratory experimentation and on-site support of scale-up activities and manufacturing operations
• Ability to work in the laboratories at the Rahway, New Jersey site with occasional domestic and international travel, as necessary. This is primarily a laboratory-based roll and onsite presence is required.
• Strong organizational, interpersonal, technical writing, and time management skills

Preferred Experience and Skills:

• Experience with Small Molecule manufacturing process
• Proven ability to work independently and collaborate effectively as part of a team
• Experience with process development in a laboratory, pilot-scale, or manufacturing environment
• Experience with developing and executing an experimental program to address issues with process design, robustness, or productivity for an existing product/process
• Familiarity with statistical design and analysis tools
• 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