Associate Director, Process Technologies and Development

* Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals* Support extremely complex technical problems related to sterile processing engineering that advance Gilead portfolio priorities* Execute studies and author reports related to container closure system compatibility and manufacturing process development* Play a key role in the establishment of a state-of-the-art sterile process engineering lab* Evaluate new/novel technologies relevant to parenteral drug product manufacturing* Represent sterile processing engineering in cross-functional project teams* Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions* Serve as a subject matter expert for development and commercial sterile processing operations* Share expertise and provide guidance/mentorship to support the growth and development of talented junior team members* Excellent verbal, written, and interpersonal communication skills are required.* Must be able to write clear, concise, and error-free documents.* Expert knowledge of FDA and cGMP standards and sterile processing. #J-18808-Ljbffr