Operations Manager (Onsite)

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. 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 Company's 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 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. 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 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: 10/6/2026 Requisition ID

R419142

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. 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 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. 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 #J-18808-Ljbffr Merck