Operations Manager (Onsite)

MSD; West Point (PA); On-site; GBP 88,000 - 139,000; Full time

Job summary

Merck is seeking an Operations Manager for the 1st shift in a GMP sterile environment. The role leads shop-floor manufacturing, ensures compliance, and drives continuous improvement across quality and operations.

You will mentor teams, manage audits, and coordinate with Quality and Technical Operations to deliver safe, compliant products. The position requires a Bachelor’s in a technical field, 3+ years of leadership in life sciences, and experience with GMP and data integrity.

Qualifications

• Bachelor’s degree in science or engineering or related technical field.
• Minimum leadership experience in regulated GMP environments.
• Experience leading teams and delivering results through others.

Responsibilities

• Provide visible, first-line supervision of manufacturing operations and personnel.
• Set daily priorities, assign work, coordinate support resources, and ensure shift handoffs.
• Lead meetings, communicate schedule and expectations, and address safety and quality risks.
• Review and approve manufacturing and compliance documentation per procedures.
• Identify capital improvement opportunities aligned with compliance objectives.
• Champion a proactive quality culture and ensure regulatory compliance.

Skills

Biochemical Analysis

Clinical Manufacturing

Dosage Forms

Team Leadership

People Leadership

Leadership

Education

Bachelor’s degree in science, Engineering or another technical field

Tools

Quality Management Systems

GMP Manufacturing

Data Integrity

Job description

Position Description

Our Company's West Point, PA site has an opening for an Operations Manager on 1st Shift within the Sterile Liquids Pilot Plant. This organization manufactures sterile drug products supporting our clinical pipeline in a highly regulated Good Manufacturing Practice environment.

Accountability & Responsibilities

Daily Shop-Floor Leadership

• Provide visible, first-line supervision of manufacturing operations and personnel.
• Set daily priorities, assign work, coordinate support resources, and ensure effective shift handoffs.
• Lead tier meetings, communicate schedule and performance expectations, and elevate safety, quality, staffing, or supply risks.
• Timely review and approve manufacturing and compliance documentation as authorized by procedures.
• Proactively identify and recommend capital improvements for the shop floor, aligned with operational excellence and compliance objectives

Quality & Compliance Leadership

• Champion a proactive quality culture that prioritizes patient safety, product quality, data integrity, and regulatory compliance.
• Serve as a quality advocate by ensuring manufacturing activities comply with current Good Manufacturing Practice, regulatory requirements, site procedures, and quality standards, with a particular focus on aseptic behaviors.
• Author/lead or contribute to investigations of manufacturing events and deviations, including complex investigations, within the assigned area, partnering with Quality and technical functions to assess root causes and identify and implement effective corrective and preventative actions.
• Maintain a state of inspection readiness and support all audits.
• Demonstrate strong knowledge of regulatory expectations, data integrity principles, quality risk management, and Good Documentation Practices.

Operational Leadership

• Ensure safe, compliant, and reliable execution of manufacturing operations while meeting production schedules and customer requirements.
• Monitor shift and area performance metrics and lead actions to address gaps
• Identify and implement opportunities to improve process robustness, cycle time, productivity, deviation reduction, and operational efficiency.
• Make and elevate risk-informed decisions consistent with procedures and quality requirements.

Continuous Improvement

• Foster a culture of operational excellence through structured problem solving and continuous improvement initiatives.
• Support value stream improvements and business process optimization efforts using Lean Manufacturing and MPS methodologies.
• Promote behaviors that improve process stability, employee engagement, and organizational effectiveness.

People Leadership

• Develop a high-performing organization through coaching, talent development, and performance management.
• Create an inclusive environment that embodies our Company Values and Enterprise Leadership Skills.

Core Competencies

• Ability to develop and lead others
• Ability to be flexible and understand risk
• Continuous improvement
• Conflict resolution
• Leadership style – adaptive; high-performance coaching; servant leader
• GMP Manufacturing
• Data Integrity
• Cross-Functional Collaboration

Required Experience and Skills

• Bachelor’s degree in science, Engineering or another technical field
• Minimum 3 years of leadership experience within Manufacturing, Quality, Technical Operations, Engineering, Validation, Supply Chain, or related life science operations.
• Demonstrated experience working in a regulated GMP environment.
• Proven experience leading teams and delivering results through others.
• Strong knowledge of current Good Manufacturing Practice regulations, Good Documentation Practices, and quality systems.
• Demonstrated experience in supporting the investigation of manufacturing events, deviations, non-conformances, audits, and operational issues.
• Ability to identify systemic issues, assess risk, and implement effective corrective actions.
• Experience working across Quality, Manufacturing, Engineering, and Technical Operations organizations.

Preferred Experience and Skills

• 2 or more years’ experience in aseptic or sterile manufacturing operations.
• Experience supporting FDA, EMA, or other global regulatory inspections.
• Experience with Quality Management Systems including deviations, corrective and preventative actions, change controls, and audit responses.
• Experience supporting teams through compliance-related challenges, regulatory feedback, or inspection readiness activities.
• Knowledge of our Company Production System, visual management, and structured problem solving.
• Experience using operational excellence and Lean methodologies to improve performance.
• Strong understanding of data integrity and quality culture expectations.

#eligibleforERP

#eligibleforERP

Required Skills

• Biochemical Analysis
• Clinical Manufacturing
• Dosage Forms
• Evaluating New Technologies
• Identifying Customer Needs
• Medical Knowledge
• New Product Research
• Patent Commercialization
• People Leadership
• Pharmaceutical Production
• Pharmaceutical Technologies
• Pilot Plant Operations
• Specification Development
• Team Leadership

Preferred Skills

Preferred Skills:

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.

Equal Employment Opportunity

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

Salary

The salary range for this role is $117,000.00 - $184,200.00

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.

Benefits

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.

Employee Status

• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Not Applicable
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): There is potential to work with Hazardous materials

Job Posting End Date

Job Posting End Date: 10/6/2026*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.

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