Assoc. Dir., Engineering

MSD•De Soto, KS

5d•$142,400 - $224,100•Onsite

About The Position

The Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) group is seeking a highly motivated individual to be part of process development group in the US. Process Development (BTS-PD) group is accountable for technology transfer of new large molecule products from R&D to commercial production. This team leads critical technical activities such as scale-up, process validation/qualification, and process optimization & robustness to ensure successful product launches to enable robust product supply. 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. The role reports to the US regional process development lead. Associate Director will be responsible for managing a high-performing team to deliver robust processes for various projects in the pipeline and transfer to manufacturing facilities. This role also requires managing strategic priorities and technical projects as needed and requires collaboration across matrix organization for collective success, including R&D, operations, site-support, supply chain and regulatory in the US region.

Requirements

Bachelor of Science in Chemical Engineering, Biotechnology, Biochemistry, Protein Chemistry, Biology or related field.
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 (4) 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

Nice To Haves

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

Responsibilities

Process Development – Accountable for development of robust processes and, right-first-time technology transfer of processes 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 – Accountable for building and sustaining a highly engaged technology transfer team through utilization of our Ways of Working. Drives culture of safety, compliance, technical excellence, and employee development. Directly manages and coaches the technology transfer team. Provides team members with aligned objectives, regular feedback on performance (including soliciting stakeholder feedback), development conversations and career progression opportunities. Proactively engages in talent management, retention, and succession planning.
Technical Excellence – Accountable for data-driven decision making across technology transfers. Drives continuous process improvements when required to enhance process and/or decrease cost-of-goods (COGs). Oversees appropriate risk identification and mitigation methodologies (e.g. FMEA) to drive decisions. Manages technical stage-gate reviews, where appropriate. When needed, accountable for driving execution of appropriate lab experiments to reduce risk, increase robustness, or reduce COGs.
Strategic Leadership – Accountable for managing strategic initiatives and overseeing execution by the technology transfer team. Additionally acts as a contributor to the Regional Technology Hoshin by aligning internal goals with the technology organization.