Associate Director, Technical Operations Drug Substance

Biopharma Careers; United States; On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck in Durham, NC is seeking an Associate Director of Technical Operations to lead drug substance manufacturing and support end-to-end process development and validation within a start-up Human Health facility. The role requires coordinating engineers and scientists, ensuring GMP compliance, and delivering quality programs across lifecycle stages.

Ideal candidates will have advanced degrees in life sciences or engineering, 7+ years in pharma operations, and strong leadership, strategic

Qualifications

• Bachelor's, Master’s, or Doctorate in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
• Minimum of four (4) years (Doctorate), six (6) years (Master's), or seven (7) years (Bachelor’s) experience in pharmaceutical operations, technical services, and/or quality operations including prior people management experience.
• Effective decision-making, problem-solving, and communication skills.
• Ability to manage multiple priorities and complex problems in a fast-paced environment.
• Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.

Responsibilities

• Provide technical leadership to the drug substance manufacturing area as part of the Technical Operations team.
• Lead cross-functional teams to address issues and achieve project milestones.
• Review and approve project documents including drug substance and process support materials.
• Support quality risk assessments and regulatory inspections.
• Ensure compliance with safety, environmental, and regulatory objectives.

Skills

Aseptic Processing

Biologics

Change Control Systems

Chemical Process Development

Cross-Functional Teamwork

Equipment Qualification

Manufacturing Process Validation

People Leadership

Process Optimization

Regulatory Inspections

Regulatory Requirements

Results-Oriented

Strategic Thinking

Technology Transfer

Education

Bachelor's, Master’s, or Doctorate in chemical/biochemical engineering or related life science

Tools

Lean Six Sigma

Job description

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state-of-the-art laboratories, manufacturing plants, and offices designed to inspire our employees as we learn, develop, and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of vaccines and biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for an Associate Director to join the technical operations team supporting a start-up of Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product and quality control laboratories.

Associate Director, Technical Operations will be responsible for providing technical leadership to the drug substance manufacturing area as part of the Technical Operations team.

Responsibilities

• Reporting to the Director, Technical Operations, the incumbent will assist in strategy development and will independently manage project assignments.
• Effectively manage a team of engineers and scientists supporting drug substance technical transfer by developing a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
• Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management, strategy development, development of standard operating procedures and master batch records, process development, and process performance qualification.
• Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
• Review and approve project documents as necessary including drug substance and process support and media technical documents, documents pertaining to utilities, manufacturing equipment and other processes, change controls, batch records, standard operating procedures, corrective and preventative actions among others.
• Act as a subject matter expert in support of quality risk assessments and regulatory inspections.
• Supports team safety, environmental, and compliance objectives.
• Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.

Qualifications

Required

• Bachelor's, Master’s, or Doctorate degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry, or related life science or engineering discipline.
• Minimum of four (4) years (Doctorate), six (6) years (Master's), or seven (7) years (Bachelor’s) experience in pharmaceutical operations, technical services, and/or quality operations including prior people management experience.
• Effective decision-making, problem-solving, and communication skills.
• Ability to manage multiple priorities and complex problems in a fast-paced environment.
• Aseptic manufacturing and GMP manufacturing experience, preferably with biological drug substance.

Preferred

• Capital project experience.
• Experience using Lean/Six Sigma tools.

Required Skills:

• API Manufacturing
• Aseptic Processing
• Biologics
• Change Control Systems
• Chemical Process Development
• Cross-Cultural Awareness
• Cross-Functional Teamwork
• Equipment Qualification
• Manufacturing Process Validation
• People Leadership
• Process Optimization
• Regulatory Inspections
• Regulatory Requirements
• Results-Oriented
• Strategic Thinking
• Technical Guidance
• Technology Transfer

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

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

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$142,400.00 - $224,100.00

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.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Location and Work Details

• 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): n/a

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

Job Posting End Date: 09/10/2026