Edison-New Brunswick Metro Area, NJ
- BS/MS in Chemical Engineering or related with 5+ years experience as a process engineering in Liquid Pharmaceutical Products. Experienced in dry powder inhalers, spray drying technology and/or lyophilized products also desired.
- Responsible for process development, characterization, scale up and tech transfer activities.
- Key member of a dynamic scientifically driven team, dedicated to the development and optimization of robust manufacturing processes for drug products.
- Key contributor to process development strategies to define manufacturing processes for clinical and commercial products.
- Manage external vendors and contractors as related to drug product manufacturing services and products.
- Assume departmental responsibilities for assigned projects and equipment.
- Maintain safety, regulatory, and compliance standards
- Strong background in pharmaceutical development as it relates to and process development/optimization.
- Demonstrated capability in execution of an experimental program to address issues of process robustness, productivity, and cost, integrating efforts with specialists in other technical disciplines. Demonstrated record of implementing novel and creative solutions to overcome process development obstacles.
- Working knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, engineering design, and statistical process control fundamentals.
- Working knowledge of cGMPs during pharmaceutical development and commercial manufacturing.
- Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment. Strong verbal and written communication skills are essential.
- Experience in the design and operation of aseptic processing equipment is a plus.