Associate Director, Process Development Large Molecules

The Associate Director is accountable for developing robust processes for new products and transferring large molecule pipeline projects from R&D to operations in the US region, reporting to the US regional process development lead. The role manages a high-performing team and requires collaboration across a matrix organization including R&D, operations, site-support, supply chain, and regulatory.

Job Responsibilities

• Process Development: Accountable for development of robust processes and right-first-time technology transfer from R&D to operations for antigens and final products to meet file-on-time and launch-on-time targets.
• Collaborate with partner groups (R&D, operations, quality, regulatory) to ensure file/launch on time.
• People Management: Build and sustain a highly engaged technology transfer team; drive culture of safety, compliance, technical excellence, and employee development.
• Directly manage and coach the technology transfer team; provide aligned objectives, regular performance feedback, development conversations, and career progression opportunities.
• Proactively engage in talent management, retention, and succession planning.
• Technical Excellence: Drive data-driven decision making across technology transfers and continuous process improvements to enhance process and/or decrease cost-of-goods (COGs).
• Oversee risk identification and mitigation methodologies (e.g., FMEA) to drive decisions; manage technical stage-gate reviews.
• Drive execution of appropriate lab experiments to reduce risk, increase robustness, or reduce COGs.
• Strategic Leadership: Manage strategic initiatives and oversee execution by the technology transfer team; contribute to the Regional Technology Hoshin by aligning internal goals with the technology organization.

Required Education

Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field.

Required Qualifications

• Bachelor's with at least 8 years of relevant post-graduate experience OR Master of Science degree and at least 6 years of relevant post-graduate experience OR doctoral degree with at least 4 years of relevant post-graduate experience.
• Minimum of 3 years of direct management experience.
• Minimum four years of relevant experience in technology transfer, process development, technical operations, or manufacturing operations within a regulated biopharmaceutical environment.
• Demonstrate as an effective project leader who can maintain oversight, manage priorities, and deliver on-time results in a complex, fast-paced matrix organization.
• Strong working knowledge of EMA, FDA, and/or USDA regulations and guidelines.
• Demonstrated commitment to Diversity, Equity, & Inclusion.

Preferred Qualifications

• Demonstrated successes with Talent Management, process development/technology transfer and strategic initiatives.
• Demonstrated experience with USDA regulations.
• Demonstrated experience in commercial biomanufacturing (sterile/aseptic, bulk drug substance, filling, lyophilization, etc.) in a regulated environment.
• Strong working knowledge of key biopharmaceutical business processes, including Process Performance Qualification/Validation, risk assessments, CMC regulatory processes, and manufacturing change control.
• Demonstrated experience with statistical process control and/or design of experiments.

Required Skills

Biopharmaceutical Industry, Coaching Employees, Decision Making, Life Sciences Industry, Life Sciences R&D, People Leadership, Process Development (PD), Technical Operations, Technology Transfer.

Preferred Skills

Design of Experiments (DOE), Strategic Technology Initiatives, USDA Regulations.