Operations Manager (Onsite)

Job Description

Position Description

Our Companys 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.

The Operations Manager is a first-line shop-floor supervisor who leads a team of manufacturing professionals and provides daily oversight of sterile manufacturing operations.

The Operations Manager is responsible for delivering operational excellence while maintaining the highest standards of Safety First Quality Always compliance and reliable delivery.

The successful candidate will drive a culture of Right First-Time execution continuous improvement inspection readiness and employee engagement while advancing our Companys Enterprise Leadership Skills and our Company Production System principles. The role requires strong cross-functional collaboration with Quality Technical Operations Engineering Validation Supply Chain and Regulatory partners to ensure compliant and efficient manufacturing operations.

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 escalate 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 escalate 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

• Bachelors 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.

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The salary range for this role is

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 employees 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. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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.

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