Senior Specialist, Operations

MSD Malaysia; Durham (NC); On-site; USD 106,000 - 167,000; Full time

Job summary

MSD Malaysia is seeking a Manufacturing Operations Senior Specialist to lead a vaccine end-to-end manufacturing process, including media prep, harvesting, filling, lyophilization, capping, inspection, packaging, testing and release.

You will coach and develop a team, drive continuous improvement, manage site cost and participate in safety and quality programs while collaborating with cross-functional teams to ensure reliable commercial operations.

Qualifications

• Bachelor or higher degree in a relevant field with manufacturing ops experience.
• Lean Six Sigma certification is required/preferred.
• Proven leadership of manufacturing teams in GMP settings.
• Experience with SAP/GLIMS or equivalent systems.

Responsibilities

• Develop, motivate, and manage a team to ensure reliable manufacturing, testing and release.
• Provide regular coaching and performance feedback to employees.
• Lead on the manufacturing floor and champion standard work across teams.
• Identify opportunities for process improvement and support implementation.
• Represent Operations on project teams and manage site cost center.

Skills

Calibration of Equipment

Change Management

Competency Management

CMMS

Customer-Focused

Driving Continuous Improvement

Enterprise Leadership

Organizational Leadership

People Management

Production Management

Education

Bachelor degree in Engineering/Life Science

Master of Science or Business degree

Tools

SAP

GLIMS

Job description

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and be part of a company that is making a difference.

Summary, Focus and Purpose

The Manufacturing Operations Senior Specialist role within our company is a manufacturing leadership role supporting a vaccine end to end manufacturing process (e.g. media preparation, harvesting, filling, lyophilization, capping and inspection, and packaging), testing and release. You must provide direction, coaching, and technical expertise to operations support personnel responsible for running/improving the manufacturing, testing and release processes and business systems. This individual must actively manage their assigned team to reliably support commercial operations (including hiring, employee development, routine 1:1 meetings and coaching, recognition, and performance management). Additionally, they must become proficient in the use of manufacturing systems and knowledgeable of site procedures to lead their team through resolving/improving manufacturing and business processes.

Key Functions

Employee Development / People Management

• Develop, motivate, and manage a team to ensure reliable manufacturing, testing and release execution
• Assign yearly performance objectives for the team in alignment with department and site goals
• Provide regular feedback and coaching to employees on work performance
• Provide leadership to the team as needed based on the team’s capabilities and maturity

Process Execution | Continuous Improvement

• Provide a leadership presence on the manufacturing floor
• Champion standard work to drive consistent use of best practices across teams
• Regularly help the team troubleshoot issues to minimize downtime and maintain product quality
• Identify opportunities to improve the process (e.g. cycle times, ease of execution, reliability)
• Support work as needed to implement improvements (e.g. scheduling, staffing, protocol execution)
• Coach team members in executing smaller improvement projects in their operational area
• Represent Operations on project teams

Communication

• Lead and support site (Tier) meetings to facilitate flow of information up/down through the organization
• Hold regular team meetings to cascade information and collect team feedback
• Provide clear consistent communication to site stakeholders
• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise
• Serve as a Subject Matter Expert (SME) during tours to provide area/process overview information to visitors/auditors upon request

Quality & Safety Compliance

• Foster strong safety culture on the team through actions, coaching, and prioritization
• Coach individuals when reporting safety issues and completing corrective/preventative actions
• Drive culture of compliance through actions, consistent quality-driven decision making, and coaching of the team (e.g. documentation, housekeeping, area 5S, etc.)
• Participate in safety/regulatory audits (i.e. tours, topic discussion)

Financial

• Manages the Site cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year
• Recognize opportunities for cost savings and communicates them for potential project chartering

Education

Bachelor degree in Engineering, Life Science, or related field with five years in a Manufacturing Operations or Site support role or prior military experience OR Master of Science or Business degree with three years of the described experience.

Required Experience | Knowledge | Skills

Medical clearance Demonstrated ability to lead a team (i.e. experience leading directly as a supervisor/coach or indirectly as part of a project or through routine process execution) Lean Six Sigma certification Demonstrated mastery of Company Production Systems, problem solving, process improvements, LEAN manufacturing practices Strong leadership and interpersonal skills, technical aptitude with the ability to learn new skills and tasks, and problem-solving skills; strong team skills and interpersonal skills including motivating/empowering others and resolving conflict Ability to manage multiple priorities and coordinate people/resources to meet a production schedule Strong interpersonal, communication, and problem-solving skills

Preferred Experience | Knowledge | Skills

Previous supervisory experience Experience in a Good Manufacturing Practice (GMP)-regulated manufacturing environment using electronic manufacturing systems (e.g. SAP, GLIMs, etc.) Experience interacting with regulatory auditors as part of area tours and/or topic discussion

Required Skills

• Calibration of Equipment
• Calibration of Equipment
• Change Management
• Competency Management
• Computerized Maintenance Management Systems (CMMS)
• Customer-Focused
• Driving Continuous Improvement
• Enterprise Leadership
• Goal Setting
• Interpersonal Relationships
• Maintenance Management
• Manufacturing Process Validation
• Mechanical Maintenance
• Meeting Facilitation
• Organizational Leadership
• Overall Equipment Effectiveness (OEE)
• People Management
• Performance Feedback
• Performance Plans
• Predictive Maintenance
• Process Implementations
• Process Improvements
• Process Instrumentation
• Process Training
• Production Management
• {+ 10 more}

Preferred Skills

US and Puerto Rico Residents Only:

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

Equal Employment Opportunity

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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. 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.

Salary

The salary range for this role is $106,200.00 - $167,200.00. 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

• 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.

Employee Status Information

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

Job Posting End Date: 09/18/2026

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.