Technical Associate Director, Process Technologies and Development

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Job Responsibilities

• Technical leadership of engineering projects related to aseptic drug product processing, facilities, and equipment

• Pathfinding in the design, optimization, and problem solving of complex systems, particularly where conventional/established approaches are not appropriate or have not succeeded

• Developing feasible timelines which reflect physics, technical and financial constraints, deliver high quality, robust solutions, address desired business outcomes, and impact business success

• Apply fundamental engineering principles to the design, development, scale-up, and validation of robust 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

• Serve as a subject matter expert for clinical and commercial drug product processing operations

• Share expertise and provide guidance/mentorship to nurture and develop the skills of talented junior team members

• Reinforce a culture of continuous learning, technical rigor, data driven decision making, and patient-oriented ethics as keys to technical and business success

• Spearhead the establishment and equipping of a state-of-the-art sterile drug product process engineering lab, including the procurement and creation of experimental apparatus, instrumentation, and tools necessary to fulfill the lab’s deliverables

• Evaluate new/novel and established technologies and/or equipment most appropriate for implementation in aseptic manufacturing of parenteral drug products

• Provide technical leadership for the build out of new clinical and/or commercial drug product manufacturing facilities and manufacturing lines

• Provide technical leadership for facility fit analysis and site selection for drug product clinical and commercial, new processes and technology transfers

• Author sections of regulatory documents (e.g., IND, NDA, IMPD, BLA, PAS) in support of global regulatory submissions

Knowledge, Experience and Skills

• B.S. degree in packaging engineering, mechanical engineering, chemical engineering, or a related scientific field and a minimum of 10 years of pharmaceutical packaging experience are required. A combination of advanced degree(s) with comparable levels of relevant industry experience is acceptable

• Excellent verbal, written, and interpersonal communication skills are required.

• Must be able to write clear, concise, and error-free documents.

• Expert knowledge of aseptic drug product manufacturing, relevant cGMP standards, regulations, health authority guidance, and health authority expectations in regions including the United States (FDA) and the European Union (EMA).

• Expert knowledge of relevant parenteral drug product pharmacopeial standards (e.g., USP, Ph. Eur., JP).

• Expert knowledge of aseptic drug product manufacturing and process engineering industrial standards (e.g., ISO, PIC/S, ISPE, ISA), best practices, and norms.

• Technical leadership experience with respect to parenteral drug products, processes, facilities, and equipment.

• Practical skills building experimental apparatus, instrumentation, and tools.

• Complex engineering data analysis.

People Leader Accountabilities:

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.