Manufacturing Changeover Manager - Drug Substance

CamWebDir; Elkton (VA); On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Paid holidays

Vacation

Job summary

Merck seeks a Manufacturing Changeover Manager - Drug Substance to plan, coordinate, and lead turnaround activities for API/Drug Substance operations at Elkton, VA. You will ensure safe, compliant execution and drive continuous improvement.

Lead a cross-skilled Turnaround team, develop standardized processes, and partner with stakeholders to enable reliable campaign transitions and operational excellence in a high-growth biopharmaceutical setting.

Qualifications

• Bachelor's degree in a technical discipline or related field; engineering preferred but not required.
• Minimum of 5 years in regulated GMP manufacturing environments.
• Experience leading turnaround, changeover, or campaign transitions.
• Strong lean/continuous improvement mindset.
• Experience leading cross-functional teams in manufacturing.

Responsibilities

• Lead planning, coordination and execution of turnaround activities for API/Drug Substance operations.
• Ensure safety, compliance and minimal disruption to operations.
• Develop a standardized turnaround model for consistent transitions.
• Coach and develop a high-performing team of mechanical, electrical, and operations personnel.
• Establish expectations, accountability and growth for team members.
• Collaborate with Production Lead and stakeholders for readiness and alignment.
• Define scope, sequencing, staffing, materials and work plans in advance.
• Drive handoffs, coordination and right-first-time execution.
• Monitor performance and identify improvements in schedule, quality, safety, and cycle time.
• Apply lean principles to eliminate waste and improve efficiency.
• Use standard work and visual management to strengthen turnaround execution.
• Track KPIs related to duration, rework and downtime.
• Foster a culture of ownership and continuous improvement.

Skills

Aseptic Manufacturing

cGMP Compliance

Data Analysis

Operational Excellence

People Leadership

Planning Ability

Education

Bachelor's Degree

Job description

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.

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}

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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 salary range for this role is $96,200.00 - $151,400.00

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.

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

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.