Senior Scientist, Engineering- Small Molecule Drug Substance Process Development Full-time NEW

Senior Scientist, Engineering

The Chemical Commercialization Technology (CCT) department, which is part of the company's 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).

Position Qualifications:

• 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

Required Experience and Skills:

• 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

Preferred Experience and Skills:

• 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.

Required Skills: Bioreactors, cGMP Regulations, Chemical Engineering, Chemical Technology, Chromatographic Techniques, Data Analysis, Design of Experiments (DOE), Good Manufacturing Practices (GMP), Manufacturing Processes, Process Development (PD), Process Optimization, Process Scale Up, Small Molecules, Technology Transfer

Preferred Skills:

Salary range for this role is $117,000.00 – $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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.