Manufacturing Changeover Manager - Drug Substance

About the role

Job Profile

At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.

At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.

Job Purpose

The Manufacturing Changeover Manager - Drug Substance is responsible for planning, coordinating, and leading highly effective turnaround activities for the Drug Substance/API operations supporting the future Small Molecule facility in Elkton, VA. This role will ensure safe, compliant, predictable, and highly efficient turnaround execution between manufacturing campaigns ensuring that turnaround targets are achieved.

The incumbent will lead a cross skilled Turnaround team in addition to operators supporting day-to-day facility operations. A key expectation of the role is to build a high-performing team culture that drives accountability, collaboration, operational discipline, and continuous improvement.

In close partnership with the Production Lead and cross-functional stakeholders, this role will establish a repeatable and standardized turnaround model that supports reliable campaign transitions, reduces downtime, and enables long-term operational excellence.

Primary Responsibilities

• Lead the planning, coordination, and execution of turnaround activities for API/Drug Substance operations.
• Ensure all turnarounds are executed safely, compliantly, efficiently, and with minimal disruption to manufacturing operations.
• Develop and maintain a standardized, repeatable turnaround model that supports consistent and predictable campaign transitions.
• Lead, coach, and develop a high-performing team of mechanical, electrical, and operations personnel, as well as operators supporting daily facility operations.
• Establish clear expectations, reinforce accountability, and support the growth and capability of team members.
• Partner with the Production Lead and cross-functional stakeholders to ensure readiness, alignment, and effective execution of turnaround activities.
• Ensure turnaround scope, sequencing, staffing, materials, and work plans are defined in advance and fully prepared for execution.
• Drive disciplined handoffs, strong coordination, and right-first-time performance across all phases of turnaround execution.
• Monitor turnaround performance and identify opportunities to improve schedule adherence, quality, safety, and cycle time.
• Apply lean principles and continuous improvement tools to eliminate waste, reduce variability, and improve operational efficiency.
• Support the use of standard work, visual management, and performance metrics to strengthen turnaround execution.
• Track and report key performance indicators related to turnaround duration, rework, downtime, and execution quality.
• Foster a culture of ownership, teamwork, continuous learning, and operational excellence.
• Support day-to-day facility operations while maintaining focus on turnaround readiness and improvement.
• Contribute to the development of the future Small Molecule operating model in Elkton, VA.

Minimum Required Education, Experience

• Bachelor’s degree required. Engineering, Operations, Manufacturing, Chemical Engineering, Pharmaceutical Engineering, or a related technical discipline preferred. Engineering degree not required.
• Minimum of 5 years of experience in pharmaceutical, biotechnology, chemical, or other regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, shutdown, campaign transition, or operational readiness activities.
• Strong continuous improvement mindset and practical understanding of lean principles.
• Experience leading teams and coordinating cross-functional stakeholders in a manufacturing environment.
• Demonstrated ability to develop standard work, operating systems, and performance metrics.
• Strong knowledge of safe and compliant execution in regulated operations.
• Proven leadership skills with the ability to coach, develop, and motivate teams.
• Strong planning, prioritization, problem-solving, and decision-making skills.
• Excellent communication and influencing skills.
• Ability to work effectively across Operations, Engineering, Quality, Maintenance, Planning, and EHS.
• Data-driven mindset with the ability to monitor performance and drive improvement.
• High attention to detail and commitment to operational discipline.

• #ELKVACOE
• #SHPE2026

Required Skills

Adaptability, Adaptability, Aseptic Manufacturing, cGMP Compliance, Cost Efficiency, Data Analysis, Efficiency Improvements, Employee Performance Standards, Expectation Management, Interpersonal Relationships, Inventory Control Management, Inventory Management, Manufacturing Quality Control, Merchandising Operations, Operational Efficiency, Operational Excellence, Operational Quality, Packaging Operations, People Leadership, People Management, Performance Improvements, Performance Metrics, Planning Ability, Procedure Adherence, Process Compliance {+ 9 more}

Preferred Skills

• Current Employees apply HERE
• Current Contingent Workers apply HERE

US and Puerto Rico Residents Only

• Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
• EEOC Know Your Rights

EEOC GINA Supplement

• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
• The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
• We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

• Learn more about your rights, including under California, Colorado and other US State Acts
• The primary location for this posting is: USA - Virginia - Elkton

Pay and benefits

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is

$96,200.00 - $151,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: No

Travel Requirements

• 10%
• Flexible Work Arrangements: Not Applicable
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): NA
• Job Posting End Date: 11/9/2026

Additional information

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.