Process engineers support API and natural products projects through all phases of late-stage development, commercialization, and product life cycle. This position is responsible for assessing key unit operations (e.g., reactions, crystallizations) for process robustness, scientific understanding, and potential scale-up risks from the lab to a manufacturing environment. Effective cross-functional interactions with other functions (e.g., technical, quality, regulatory) and on-site manufacturing personnel are key for successful job performance.
Purpose
Lead research and/or project activities with a group of scientists within the individual’s area of expertise by effectively mentoring, guiding and/or supervising scientific personnel. Oversee the design, implementation, and optimization of processes for key modalities (e.g., small molecule APIs, antibody drug conjugates, peptides, and natural products) from development to commercialization. Independently conceive, execute and communicate novel multi-disciplinary research or development strategies that achieve project and area goals. Serve as a lead scientist on his/her own project and contribute scientific insights into multiple other projects.
Responsibilities
- Leverage core chemical engineering principles (chemical kinetics, transport phenomena, thermodynamics, mathematical modeling) in experimental design, thought process in problem-solving, and data analysis.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance.
- Effectively function as a principal investigator, generating original technical ideas and research or development strategies.
- Demonstrate creative 'out of the box' thinking to solve difficult problems and champion new technologies to achieve project goals.
- Independently responsible for project science within his/her area of expertise on one or more project teams.
- Make significant contributions to project team through lab-based, or other work environments, activities.
- Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
- Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
- Primary author of publications, presentations, regulatory documents and/or primary inventor of patents. Present at leading scientific conferences.
- Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.