Assoc. Dir., Engineering

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.

• →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.

• 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

• 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

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.