Job Description

The Polysaccharide Vaccine (PV) Building 63 Operations team is seeking a highly motivated individual to fill an open Operations Associate Director position to lead the start-up of a new bulk vaccine manufacturing facility and its transition to routine manufacturing at the West Point site. The new facility is currently in the last stages of the process performance qualification process to support the successful licensure of the facility and process. Our manufacturing Operations teams are the people that make our products - we work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement.

The Associate Director, B63 Operations, is the bulk vaccine manufacturing and associated support areas business unit manager who actively supports, participates in, and embraces an empowered team culture. In this role, the Associate Director will manage an operations sub-team within the organization through process performance qualification and routine manufacturing. This role will interface with a cross-functional group that includes West Point Technical Operations, Quality, Engineering Maintenance and Utilities, Automation, Safety, and others. Unit operations include but are not limited to bulk vaccine drug substance manufacturing (fermentation and purification), and the weigh and dispense, sterile supply, and solution preparation areas that support the vaccine manufacturing. Additional responsibilities include:

Accountability

• Lead a team of direct reports to complete successful start-up of bulk vaccine manufacturing process and associated support areas within the new manufacturing facility

• Support change control, risk assessments, impact assessments, and qualification activities required for regulatory submission for facility. Support regulatory inspections of facility

• Ensure that area objectives are achieved while reliably supplying quality product at a competitive cost consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment and safety

• Facilitate tactical and strategic area management including collaboration with indirect staff and USW shop floor personnel

• Promote the behaviors and principles that drive continuous improvement

Duties

• Compliance – responsible for creating and sustaining a culture that ensure that compliance (Safety, Environment, cGMP, etc) are imperatives for the business. Responsible for establishing a Right First Time culture by reducing waste and constantly driving continuous improvement. Responsible for reviewing and approving compliance documents, as per procedures or need.

• Supply – Lead daily area walkthrough. Exercise independent judgment and decision making to ensure quality product is reliably produced while managing cost. Responsible for area supply performance metrics (Schedule Adherence, Release on Time, Product Lead Time, customer service performance, etc.).

• Continuous Improvement – Accountable for developing a continuous improvement culture while achieving our Company's Production System targets and business results for the area. Develop strategic initiatives related to the manufacturing process, equipment, and human resources in support of long-range operating plans. Report area monthly metrics and any action plans to address gaps to the Integrated Process Team (IPT) leadership team. Identify, prioritize, and champion improvement projects using diverse perspectives (safety, compliance, automation, equipment, process, and people) to increase process efficiency and yield, and reduce cycle time, process variability, and deviations, and eliminate waste.

• Financial Stewardship – Responsible for development and management of the area operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing costs. Ensure development of team’s business acumen and understanding of how they impact business finances.

• People Management – Responsible for creating and sustaining a highly engaged workforce through utilization of our company's Leadership Behaviors and Inclusion. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Provide coaching on professional development and career paths. Support IPT Talent Management.

In accordance with policy, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

Education Minimum Requirements:

• Bachelor’s Degree in Engineering, Science, Business Administration, or other technical field

Required Experience and Skills:

• Minimum five (5) years of experience in more than one functional area such as Operations, Quality, Technical Operations, Engineering, Maintenance, Automation, and/or Supply Chain

• Concurrently, a minimum of two (2) years of line experience, with responsibility for direct reports

• Demonstrated leadership and teamwork skills, excellent technical and/or mechanical troubleshooting abilities, established written and verbal communication skills

Preferred Experience and Skills:

• Minimum of two (2) years experience in relevant manufacturing or processing (bulk aseptic/sterile or low bioburden vaccine manufacturing)

• Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing

• Demonstrated ability to create an engaged workforce using Inclusion as the How

• Demonstrated experience of interacting with site, divisional, or regulatory audits

• Demonstrated success with Talent Management

Current Employees apply HERE

Current Contingent Workers apply HERE

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$126,500.00 - $199,100.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Phenol, Ethanol, Sodium hydroxide, CIP chemicals, IPA

Required Skills:

Aseptic Operations, Communication, Cost Management, Decision Making, Good Manufacturing Practices (GMP), Human Resource Management, Improvement Projects, Lean Manufacturing, Lean Six Sigma Process Improvement, Long Term Planning, Manufacturing Processes, Manufacturing Quality Control, Packaging Processes, People Leadership, People Management, Process Improvements, Production Ramp Up, Production Scheduling, Regulatory Inspections, Risk Assessments, Strategic Thinking, Team Leadership, Technical Problem-Solving

Preferred Skills:

Job Posting End Date:

08/14/2025

*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.