Director, Engineering

Merck • Rahway, NJ

23h • Hybrid

About The Position

The Microbial Process Operations (MPO) Team is seeking a Director to provide operational, technical, and strategic leadership for MPO laboratories and capabilities supporting enzyme process development and characterization. Our team is part of Biocatalysis within the Small Molecule Process Research & Development (SMPRD) group, focused on advancing technologies for the manufacturing of a diverse small molecule portfolio. The Director will collaborate cross-functionally to shape departmental and project strategy, and drive operational excellence, ensuring robust, scalable, and compliant microbial fermentation processes. The chosen candidate should possess strong interpersonal, communication, and collaboration skills, and should embrace and model our core values of diversity and inclusion and foster a supportive culture where all employees can thrive.

Requirements

• Expertise in aseptic techniques and fermentation process control strategies for batch and fed-batch processes.
• Experience implementing or driving adoption of process analytical technologies (PAT), automation, or data pipelines, with proven ability to translate data into process decisions.
• Proven experience with operation and troubleshooting of bioreactors at various scales, including mini bioreactors, bench scale, and pilot scale systems, with strong problem-solving skills for both equipment and process challenges.
• Demonstrated success leading scale-up and technology transfer from R&D to pilot and commercial manufacturing scales.
• Understanding of statistical data analysis, design of experiments, and data visualization tools to support process optimization and operational excellence.
• Excellent organizational, documentation, and problem-solving skills, with a strong commitment to maintaining rigorous safety and quality standards.
• Demonstrated ability to influence technical direction and decision-making beyond direct line authority, leveraging strong internal networks.
• Demonstrated leadership ability to guide multiple agile teams and complex programs, balancing technical risk, timelines, and resourcing, while fostering a culture of continuous improvement, safety, and operational excellence.
• Demonstrated experience leading high-impact projects or platforms, being leveraged as a technical expert and advisor across multiple areas.
• Ability to collaborate effectively across multidisciplinary teams and promote diversity, equity, and inclusion in the workplace.
• Commitment to driving process robustness, reproducibility, and scalability through data-driven risk management and continuous improvement initiatives.

Nice To Haves

• Proven track record of driving process improvements that enhance yield, quality, and operational efficiency.
• Experience with downstream unit operations such as microfluidization, continuous centrifugation, tangential flow filtration, and precipitation.
• Experience with Ambr250 mini bioreactor platform.
• Understanding of microbial strain development and genetic engineering techniques to support process optimization.
• Experience working in a regulated environment (e.g., cGMP) supporting biopharmaceutical or enzyme manufacturing processes.
• Knowledge of quality systems, regulatory requirements, and documentation practices in bioprocess development.
• Prior experience mentoring or supervising junior scientists and engineers in a laboratory or manufacturing setting.

Responsibilities

• Lead the design, execution, and analysis of complex fermentation experiments at multiple scales (e.g., mini bioreactors, benchtop bioreactors, pilot scale), ensuring high-quality, reproducible results.
• Oversee downstream processing operations to ensure efficient enzyme recovery and purification, delivering high-quality enzyme powders that meet quality and yield specifications.
• Ensure timely, accurate, and comprehensive documentation of all experimental work and process data in compliance with company standards, setting expectations and standards for documentation quality and practices across the team and interfacing groups.
• Lead the team in troubleshooting and resolving operational issues related to bioreactor and downstream process to ensure consistent, reliable, and robust operations, anticipating risks and guiding resolution strategies with broad technical and business impact.
• Lead and prioritize initiatives to improve process efficiency, reproducibility, and scalability, incorporating automation, data visualization pipelines, and process analytical technologies, shaping longer-term capability roadmaps and investment areas for MPO.
• Champion laboratory safety, compliance, and best practices, setting the tone and expectations for operational excellence, accountability, and continuous improvement across the team.
• Mentor and provide technical guidance to junior scientists and associates, promoting knowledge sharing, skill development, and adherence to operational discipline.
• Collaborate with cross-functional teams and external partners to support technology transfer, scale-up activities, and process robustness, serving as a technical expert and strategic partners across multiple programs.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees