Associate Director, Technical Operations (Drug Substance)

Job Description

Welcome to the Future of Precision Oncology - Join Us in Wilmington, DE!

We're thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware-a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it's a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we'll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment-one molecule at a time.

In this position the Technical Operations Associate Director will play a pivotal role in ensuring oversight of various aspects of manufacturing, change management and technology transfer of programs to the site. In partnership with site manufacturing team will provide comprehensive manufacturing and technical leadership to the DS organization supporting the continued build, commissioning and qualification. This position will continue within the role from design through operation of the facility.

Responsibilities

• Lead and engage with the engineering design firms in detailed design on all aspects of drug substance manufacturing.
• Lead and drive the Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Develop project appropriate guidance documents as necessary.
• Execute automation sprints as necessary in the drug substance area.
• Support equipment qualification deliverables including equipment Commissioning & Qualification, IOQ, etc.
• Creation, review and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise to the manufacturing team and leadership of the Technical Operations team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
• Oversee the Engineering Batches, Process Performance Qualifications and commercial manufacturing including authoring relevant filing sections.
• Provide technical leadership for new product introductions (Tech Transfer).
• Support technical deliverables within Drug Substance to support the successful product launch.
• Provide manufacturing and technical support for RFT implementation and execution.
• Communicate complex technical issues to stakeholders, external customers, agencies.

Qualifications

Required

• Bachelor's degree in engineering, science or related discipline.
• Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
• Demonstrated ability to lead and operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of shakedown batches engineering batches, developmental batches and PPQ runs.
• Ability to adapt to changing priorities as project demands change.
• Demonstrated skills in planning, communication (oral and written) and technical writing.

Preferred

• Start-up experience in a large-scale commercial drug substance facility highly desirable with hands-on experience with antibody drug conjugates highly preferred.
• Expertise in chromatography and TFF operations will be advantageous.
• Previous experience with CQV activities will be advantageous.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.

#ADC

Required Skills:
Antibodies, Antibodies, Antibody Drug Conjugates (ADC), API Manufacturing, Change Control Systems, Change Request Management, Chemical Process Development, Chromatography, Cross-Cultural Awareness, Cross-Functional Teamwork, Detailed Design, Deviation Management, Equipment Qualification, Factory Acceptance Test (FAT), GMP Compliance, Hazard Analysis, Immunochemistry, Manufacturing, Manufacturing Process Validation, Operational Acceptance Testing (OAT), People Leadership, Process Optimization, Production Supervision, Regulatory Inspections, Regulatory Requirements {+ 8 more}

Preferred Skills:

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:

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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

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.

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 .

You can apply for this role through (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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
08/6/2026
*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: R389438