Principal Scientist, Process Development & Commercialization

Job Description

Job Summary:

Our Company is seeking a highly motivated and collaborative scientist/engineer to join our team. This is a unique opportunity to play a key role in advancing late-stage small molecule programs from development to commercialization while leading highly visible technical initiatives across our global network.

The Principal Scientist, Engineering position leverages scientific and engineering expertise to develop safe, robust, and scalable manufacturing processes through process characterization, technology transfer, process validation, regulatory filing support, and commercial supply activities.  

This role offers significant technical leadership, exposure to cross-functional decision-making, and opportunities to influence both internal and external development and manufacturing strategies.

The successful candidate will lead and mentor technical staff responsible for planning and executing process characterization studies, developing regulatory filing strategies, and implementing technology transfers to commercial manufacturing sites. In addition, you will apply Quality Risk Management principles, statistical design of experiments (DOE), and data-driven decision making to ensure successful process development and commercialization.

A strong commitment to safety, quality, and compliance is essential. The successful candidate will operate in accordance with current Good Manufacturing Practices (cGMPs), participate in risk assessments and deviation investigations, and champion Good Documentation Practices (GDPs) throughout development and manufacturing activities.

Position

Qualifications:

Education Bachelor's or master's degree in chemical engineering or a related scientific discipline from an accredited institution, with a minimum of 11 years of relevant experience in process development; orPh.D. in Chemical Engineering or a related scientific discipline, with a minimum of 7 years of relevant experience following completion of the doctorate.

Required

Experience and Skills:

Demonstrated experience in chemical process development, including:

Developing and executing experimental programs to address process design, robustness, scalability, productivity, and process understanding

Leading process characterization activities and applying scientific principles to establish robust manufacturing processes

Leading regulatory filing support activities, including process characterization, control strategy development, and process validation planning and execution

Mentoring and developing technical staff through laboratory execution, data analysis, and scientific problem-solving

Working effectively within cross-functional teams to drive complex development programs

Strong communication, organizational, technical writing, interpersonal, and project management skills

Demonstrated ability to lead technical teams and influence decision-making across multiple stakeholders

Preferred

Experience and Skills:

Hands-on experience in laboratory-based process development, including unit operations commonly used in small molecule drug substance development such as chemical reactions, work-up operations, isolation, and crystallization

Experience leading technical interactions with external partners, suppliers, and contract manufacturing organizations

Expertise in statistical experimental design and data analysis

Familiarity with the application of cGMP principles in pharmaceutical drug substance and/or drug product development and manufacturing

Experience applying Quality by Design (QbD) principles, mathematical modeling, and engineering scale-up methodologies

Experience supporting commercial product launches and post-approval process improvements

Required Skills:

API Manufacturing, Chemical Engineering,…