Director, Chemical Technical Operations, North America External Manufacturing
About the role
The Chemical Technical Operations Director for North America API External Manufacturing (ExM) leads the Technical Operations team in support of the manufacturing of Active Pharmaceutical Ingredients, intermediates, and drug product intermediates at external contract manufacturing facilities in the region.
Responsibilities
Partner across ExM Operations, ExM Quality, Business Development, Supply Chain Management, and Global Procurement to support API supply, including intermediates and other critical materials in the areas of new product introductions, sustained commercial supply, risk management and sourcing.
Lead and develop a diverse team to enable evolving business needs.
Work across functions to develop and enable realization of strategic initiatives aligned with company priorities.
Requirements
Leadership experience in one or more roles in Technical Operations, Process Development, Manufacturing, Quality Operations or Engineering.
Demonstrated experience with traditional API processing as well as introducing new technologies and ways of working.
Familiarity with use of biocatalysts, enzyme manufacturing, flow chemistry, processing of highly potent compounds, or sterile/low bioburden DS manufacturing.
Ensure strong technical capability is developed for new products as part of acquisition and commercialization, and an appropriate control strategy is realized.
Frequent travel about 25%.
Qualifications
Bachelor's in a technical field (Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) with minimum 10 years of relevant pharmaceutical industry experience; or Master’s with minimum 7 years of relevant experience; or PhD with minimum 5 years of relevant experience.
Skills
Cross-Functional Leadership
Decision Making
External Manufacturing
GMP Compliance
Leadership
Manufacturing
Results-Oriented
Sterile Filling
Benefits
Annual bonus and long-term incentive, if applicable.
A comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
Flexible work arrangements, hybrid shift 1st - Day, valid driving license, no hazardous material(s).