Associate Director, Operations

Merck; Durham (NC); On-site; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck in Durham, NC seeks an Associate Director of Operations for a capital project start-up. You will build and lead a manufacturing team across drug substance/product processes, utilities, and QC labs, guiding strategy and cross-stakeholder communications to launch operations.

You will provide technical leadership, ensure schedule conformance, support process improvements, and drive a strong safety culture within a GMP environment.

Qualifications

• Bachelor's degree in Engineering, Science, or related field AND at least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry
• A Master's Degree AND at least six (6) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry
• Routine commercial manufacturing experience
• Direct and/or indirect leadership experience of teams and/or projects, including coaching and developing people
• Strong communication skills with the ability to present complex data sets to diverse audience with varying business acumen
• Demonstrated technical expertise during regulatory inspections and audits
• Demonstrated project management and analytical skills

Responsibilities

• Hire, coach, and develop a team of managers and technicians
• Ensure execution to schedule
• Own projects and drive improvements
• Create a strong safety culture
• Contribute to facility strategy for manufacturing
• Direct routine process support and improvement activities
• Serve as SME during regulatory inspections and audits
• Provide technical guidance for daily production, projects, deviations and changes
• Contribute to the facility leadership team and budget-driven plans
• Adapt plans based on division scorecard and resource needs

Skills

Aseptic Operations

Biopharmaceutical Industry

Biopharmaceuticals

Biopharmaceutics

Bioproducts

Capital Projects

Commercialization

Decision Making

Global Manufacturing

GMP Compliance

Good Manufacturing Practices (GMP)

Lean Manufacturing

Manufacturing Operations

People Leadership

Pharmacology

Process Manufacturing

Production Scheduling

Regulatory Compliance

Strategic Thinking

Team Leadership

Education

Bachelor's degree in Engineering, Science, or related field

Master's Degree

Job description

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a \"Safety First, Quality Always, Inclusion for All\" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Position Description

We are seeking an Associate Director, Operations for a capital project start-up in Durham, North Carolina. The Associate Director will oversee a portion of the manufacturing team. The facility includes end-to-end processing of drug substance, drug product, including culture growth, harvest, filling, lyophilization, product inspection, utilities, warehouse, and quality control laboratories. The Associate Director is accountable for building and leading the manufacturing team and strategy, as well as providing communication across various stakeholders to establish start-up of and execute the manufacturing process.

Duties of the Associate Director include but are not limited to:

• Hiring, coaching, and developing a team of managers and technicians


• Ensure execution to schedule


• Ownership for projects and improvement


• Creating a strong safety culture


• Contributing to the manufacturing team strategy for the facility


• Directing routine process support and improvement activities


• Serving as technical SME during regulatory inspections and audits.


• Providing technical guidance for daily production, projects, deviations and changes.


• Contributing to the facility leadership team, strategy, and guiding facility operations.


• Adapts plans and priorities based on departmental budget and profit plan to address resource and operational challenges


• Decisions are guided by policies, procedures and business plan; receives guidance from manager


• Provides technical guidance to employees, colleagues or clients


• Ensure compliance to Corporate, Site, and Departmental procedures associated with the manufacturing of vaccine product, and ensuring team is trained on new or revised processes or procedures


• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units


• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges


• Other duties as requested by Management

Position Qualification

• Bachelor's degree in Engineering, Science, or related field AND at least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR


• A Master's Degree AND at least six (6) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry


• Routine commercial manufacturing experience.


• Direct and/or indirect leadership experience of teams and/or projects, including coaching and developing people


• Strong communication skills with the ability to present complex data sets to diverse audience with varying business acumen.


• Demonstrated technical expertise during regulatory inspections and audits.


• Demonstrated project management and analytical skills

Preferred Experience And Skills

• Experience with Good Manufacturing Practice (GMP) operations, tech transfer, capital projects, facility start-up, production, and improvement projects


• Strategic, end-to-end thinking


• Experience in regulated or GMP manufacturing and/or technical support of manufacturing operations


• Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities


• Familiarity with change control systems and technical assessment of change in a current GMP production environment


• Experience with sterile processing and sterility assurance practices and guidelines

Required Skills

Aseptic Operations, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Bioproducts, Capital Projects, Commercialization, Commercial Loan Restructuring, Decision Making, Global Manufacturing, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Operations, People Leadership, Pharmacology, Process Manufacturing, Production Scheduling, Regulatory Compliance, Strategic Thinking, Team Leadership

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.

Requirements

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 Range for this role

$129,000.00 - $203,100.00

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.

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

08/26/2026

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.

Requisition ID

R410340