Purpose:
Process Engineers in Product Development Science & Technology support API projects through all the phases of late stage development, commercialization, product life cycle. This position will be responsible to ensure processes can be run safely, addressing scale-up issues and developing and implementing robust API process steps from the lab to a manufacturing environment. Once commercialized, the Process Engineer is responsible for continuous improvement activities, technical transfer to manufacturing sites, and resolution of technical manufacturing issues in a commercial setting. Effective cross functional interactions with quality and regulatory functions and on-site manufacturing personnel is key for successful job performance.
The Peptide Process Engineer will research and/or conduct project activities with a group of scientists within the individual’s area of expertise by effectively mentoring, guiding, and/or supervising scientific personnel. Independently conceive, execute, and communicate novel multi-disciplinary research or development strategies that achieve project and area goals. This role will oversee the design, implementation, and optimization of peptide synthesis manufacturing processes from development to commercialization.
Major Responsibilities:
- Develops and achieves discipline strategy in alignment with functional goals and key scientific objectives.
- Conceptualizes and implements approaches using combinations of engineering principles.
- Utilizes knowledge of engineering, literature, and experience to guide decision for complex situations.
- Collaborates with experts within function to integrate scientific objectives into activities associated with development of new/improved products or technology.
- Advances scientific expertise within function. Proactively advises and shares knowledge and expert opinions with subordinates, peers, and senior management. Mentors and trains functional colleagues and assesses current and emerging business challenges enabling functional goal achievement.
- Ensures quality and effectiveness of key results of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
- Sources and identifies emerging scientific trends from multiple internal and external sources and assess relevance. Integrates trends into functional short-term objectives. Advances technology and direction within area of discipline.
Level of Leadership Activities:
- Leads resolution of compliance quality issues and documents drafting.
- Presents results of projects both internally and externally.
- Reviews and critiques presentations for others.
- Establishes project operation criteria and technical standards for excellence. Generates new product ideas.
- Prepares and aligns impact goals with department divisional goals.
- Actively participates in cross-functional technology transfer teams including team members from development and manufacturing.