
Director, Chemical Technical Operations, North America External Manufacturing
Merck, Lincoln, NE, United States
Job Description
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 provides leadership and expertise in technical oversight, portfolio management, continuous improvement, talent development, and upskilling the organization’s 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, oversees external contract manufacturing facilities in the North America region. The director leads and develops a diverse team to enable evolving business needs and collaborates across functions to realize 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 for new product introductions, sustained commercial supply, risk management, and sourcing.
- Coach and develop the team, overseeing career development plans for direct reports.
- Build and sustain a high-performance, flexible, and innovative organization that drives continuous improvement.
- Apply operational excellence methodologies to streamline work processes for improved efficiency and effectiveness.
- Ensure technical excellence in routine supply support to contract manufacturers.
- Lead technical efforts for enhancing competitiveness through targeted process optimization.
- Advance proactive process monitoring to enable robust manufacturing operations and early detection of process issues.
- Foster a culture of sharing, curiosity, learning, and end-to-end mindsets for new technologies, ways of working, and product introductions.
- Develop technical skill and capability of both internal and external teams to meet evolving pipeline and business needs.
- Create a robust technical network of internal and external resources for cross‑functional problem solving.
- Leverage the broader technical organization and communities of practice to enhance knowledge management across the CTO team.
- Direct safe and compliant resolution of complex technical or business challenges through a data‑driven approach, using knowledge of applicable government and company quality, safety, regulatory, and trade compliance requirements.
- Partner with Operations and Quality Assurance to establish compliant and robust manufacturing capabilities at partner CMOs.
- Steer oversight of process scale‑up and optimization, new technology deployment, pre‑approval inspection readiness, validation protocol development, and execution of process validation (Process Performance Qualification) and continual validation at external suppliers.
- Collaborate with other functions to develop and lead strategies supporting future business initiatives and objectives.
Education Requirement
- Bachelor’s in a technical field (Chemical Engineering, Biochemical Engineering, Chemistry, or Pharmaceutical Sciences) with a minimum of 10 years of relevant pharmaceutical industry experience.
- Master’s with a minimum of 7 years of relevant experience.
- PhD with a minimum of 5 years of relevant experience.
Qualifications
- Leadership experience in one or more roles in Technical Operations, Process Development, Manufacturing, Quality Operations or Engineering.
- Ability to partner with other areas to resolve highly complex technical issues that could impact continuity of supply.
- Demonstrated experience with traditional API processing and with introducing new technologies and ways of working.
- Familiarity with biocatalysts, enzyme manufacturing, flow chemistry, processing of highly potent compounds, or sterile/low bioburden DS manufacturing is advantageous.
- Ensure strong technical capability for new products as part of acquisition and commercialization, and realize an appropriate control strategy.
- Travel about 25% of the time.
Required Skills
Cross‑Functional Leadership, Decision Making, External Manufacturing, GMP Compliance, Leadership, Manufacturing, Results‑Oriented, Sterile Filling
Benefits
We offer a comprehensive package of benefits, including medical, dental, vision, healthcare and other insurance benefits for employees and families, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at
Salary
$173,200.00 - $272,600.00. The salary range reflects the lowest to highest amount we would pay for this role in good faith at the time of posting. Placement within the range depends on education, qualifications, experience, skills, location, and business needs.
The successful candidate may be eligible for an annual bonus and long‑term incentive, if applicable.
Legal Notice
We are an Equal Employment Opportunity Employer, providing equal opportunities to all employees and applicants for employment and prohibiting discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC website or related state resources.
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