Sr. Chemical Process Engineer

Corden Pharma

Corden Pharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals drug products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people's lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms:
Peptides, Lipids, & Carbohydrates;
Injectables;
Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

Chemical process engineer targeting complex small molecules, peptides, and highly actives for active pharmaceutical ingredients. Performs research and development activities for the purpose of designing/improving a process or technology. And provides process engineering support for manufacturing processes in assigned group, or plant, through proactive problem prevention and troubleshooting, as well as identifying and implementing process improvements. Provides leadership and project management to work groups on large scale projects and technology transfers.

Include the following. Other duties may be assigned.

• Knowledge of plant scale unit operations, scale-up, and plant design considerations, especially as they apply to the production of APIs
• Broad understanding of chemical reactivity, potential exotherms, cross-reactivity, side products, and waste streams
• Evaluating new process fits into manufacturing, having good understanding of process fit issues – safety factors, standard cost, equipment, chemistry, and unit operations
• Performing process development at the lab scale, concentrating on key scale-up parameters to scale up from kilo-scale to full production scale
• Supporting manufacturing through authoring operating procedures, SOPs, guidelines, PSI packages, developing process models, and assembling technology transfer packages
• Participating in or leading technology transfer from one manufacturing site to another; developing and implementing innovative process scale-up technologies.
• Performing process validation on an API process.
• Knowledge and application of QEH&S regulatory compliance principles related to chemical and pharmaceutical manufacturing, including FDA, cGMPs, EPA, OSHA, and PSM requirements
• Position may require day-to-day support to manufacturing and process development, at times requiring attention outside of the normal work hours. Support includes troubleshooting and continuous improvement of equipment and processes, as well as participation in change control, deviations, and investigations
• Identifying, evaluating, developing, and implementing process improvements and optimization that reduce costs; improve yield, cycle times and product quality; resolve or prevent environmental, health and safety impacts; reduce down time; improve process consistency; and improve process robustness
• Developing and implementing detailed plans for projects, including successful technology transfers, and implementing processes into pilot and commercial-scale facilities, providing leadership and technical project management

This position has no direct reports but is responsible for providing leadership for continuous improvement of processes. Periodic assignments of significant responsibility levels for large projects and technology transfers.

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may…