Process Engineers in PDS&T API projects through all the phases of late stage development, commercialization, and the product life cycle. This position will be responsible to ensure processes can be run safely, developing and implementing robust small molecule and peptide API process steps and control strategies 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.

Major Responsibilities:

Conceptualizes and implements approaches using combinations of engineering scientific principles relevant to laboratory, pilot and commercial scale manufacturing processes.
Demonstrate the ability to resolve key project hurdles and assumptions by effectively utilizing available information and technical expertise.
Proactively seek out new information in the literature and utilize knowledge of engineering and experience to incorporate this into individual project(s) as well as the overall program.
Seize opportunities to pursue leads that are in line with the project team and/or group’s strategy.
Maintain a high level of productivity in the lab and/or in transfer to and support of manufacturing facilities.
Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug, and GxP compliance.
Applies strong technical writing skills to produce reports and document; write independently. Utilizes numerous analytical instruments and may trains others in their operation.
May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

Level of Leadership Activities:

Presents results of projects both internally and externally.
Reviews and provides feedback of others’ presentations.
Actively collaborates in cross-functional process development and technology transfer teams including team members across functions.
Demonstrates strong verbal, written and presentation skills.

Preferred Qualifications:

Possess thorough theoretical and practical understanding of own scientific discipline.
Effective writer and communicator of research or other regulatory materials.

Senior Scientist, Engineering II