Technical Operations Associate Director

Description

The Technical Operations Associate Director leads the a team accountable for process development, process validation, scale-up technology transfer, and manufacturing / packaging; including technical analysis and assessment of the CMOs manufacturing capabilities, and equipment process excellence, product robustness, and designing, implementing and executing risk assessments. Has direct oversight of a team of Tech. Ops members that perform activities for R&D pipeline product projects, including planning and coordination of engineering batches, submission batches, scale up to commercial production size, through product and cleaning validation. The Technical Operations Associate Director, will be accountable for the performance and development of their team of direct reports. This position also supports technical assistance on previously developed and launched products.

Plans, develops, and directs operations with resources enabling the safe, compliant and opportune manufacture of product. Supports the development of new products through registration and commercialization including Sterile Injectables (IV Bag, PFS, Vial) and Oral Solid Dosage forms (Oral suspensions, Capsules and tablets), ensuring safety and efficacy for intended use. Participates on cross-functional teams to address specific problems, facilitate discussion and research, and enable operation to become more efficient.

The incumbent must be capable of managing a number of increasingly complex projects where analysis of situations or data requires an in-depth evaluation of various factors.

Promotes a positive working environment, and acts as a mentor to other members of the Technical Operations team. Collaborates with internal and external cross-functional teams to ensure projects are completed on time and adhere to strategic goals and objectives. Proactive leader who is accountable to provide expert technical opinion to management to assist in formulation and execution of strategic planning to ensure the operation is positioned to meet or exceed industry and regulatory expectations. Ensures operations are carried out with a consistent approach and on a timely basis in line with the strategy as well as applicable regulatory requirements.