Director, Chemical Technical Operations, North America External Manufacturing

Chemical Technical Operations Director

The Chemical Technical Operations Director for North America API External Manufacturing (ExM) leads the Technical Operations team in support of the manufacturing of Active Pharmaceutical Ingredients, intermediates, and drug product intermediates at external contract manufacturing facilities in the region. The successful candidate will provide leadership and expertise in technical oversight, portfolio management, continuous improvement, talent development and upskilling organization capabilities. This position reports to the Executive Director, Chemical Technical Operations (CTO), Small Molecule Science & Technology.

The Director of Chemical Technical Operations, as part of the External Manufacturing regional leadership team, is responsible for oversight of external contract manufacturing facilities in the North America region. The successful candidate will lead and develop a diverse team to enable evolving business needs. As part of the CTO Leadership Team & API Platform extended leadership team the individual, working across functions, will develop and enable realization of strategic initiatives aligned with company priorities.

Primary Responsibilities:

• Partner across ExM Operations, ExM Quality, Business Development, Supply Chain Management, and Global Procurement to support API supply, including intermediates and other critical materials in the areas of new product introductions, sustained commercial supply, risk management and sourcing.
• As a people manager, coach and develop the team to enable realization of priorities and provide oversight of career development plans for their direct reports.
• Develop and sustain a high-performance organization that is highly flexible and motivated to champion change and innovation to drive continuous improvement in outcomes.
• Leverage operational excellence methodologies to streamline ways of working for improved efficiency and effectiveness.
• Ensure technical excellence in routine supply support to contract manufacturers.
• Lead the technical efforts required for enhancing competitiveness through targeted process optimization.
• Drive organizational capability in Proactive Process Monitoring to enable robust manufacturing operations & early detection of process issues.
• Foster a community of sharing, curiosity, learning, and end-to-end mindsets for new technologies, ways of working & new product introductions.
• Ensure technical skill and capability building of both internal and external teams to meet our evolving pipeline & business needs.
• Create a robust technical network of internal and external resources, rapidly deployable to solve complex problems in a cross-functional manner.
• Leverage the broader technical organization and communities of practice, ensuring strong knowledge management mindsets across the CTO team.
• Directs the safe & compliant resolution of complex technical or business challenges through a data-driven approach and knowledge of applicable government and company quality, safety, regulatory and trade compliance requirements.
• In support of product commercialization and externalization, partner with Operations and Quality Assurance to establish compliant and robust manufacturing capabilities at our partner CMOs.
• Steer oversight of process scale-up and optimization, new technologies deployment, technical aspects of pre-approval inspection readiness, development of validation protocols, and execution of process validation (Process Performance Qualification) and Continued Process Verification at external suppliers.
• In partnership with other functions, develop and lead strategies in support of meeting future business initiatives and objectives.

Education Requirement:

Bachelors in a technical field (Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) with minimum 10 years of relevant pharmaceutical industry experience; or Master's with minimum 7 years of relevant experience; or PhD with minimum 5 years of relevant experience.

Qualifications:

Leadership experience in one or more roles in Technical Operations, Process Development, Manufacturing, Quality Operations or Engineering.

The Director will partner with other areas to rapidly and expertly resolve highly complex technical issues that could impact the continuity of supply.

Demonstrated experience with traditional API processing as well as introducing new technologies and ways of working is necessary.

Familiarity with use of biocatalysts, enzyme manufacturing, flow chemistry, processing of highly potent compounds, or sterile/low bioburden DS manufacturing is advantageous.

The individual must ensure strong technical capability is developed for new products as part of acquisition and commercialization, and an appropriate control strategy is realized.

This position involves frequent travel about 25%.

Required Skills:

Cross-Functional Leadership, Decision Making, External Manufacturing, GMP Compliance, Leadership, Manufacturing, Results-Oriented, Sterile Filling

Preferred Skills:

Salary range for this role is $173,200.00 - $272,600.00. 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.