MSD
Associate Director, Drug Substance Operations – Wilmington Biotech
MSD, Wilmington, Delaware, us, 19894
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.
ADC’s represent one of the most exciting frontiers in biopharmaceuticals today. By combining the targeting power of monoclonal antibodies with the potency of cytotoxic drugs, ADCs deliver cancer‑killing agents directly to tumor cells, minimizing damage to healthy tissue. This precision has revolutionized treatment for hematologic malignancies and is rapidly expanding into other cancers. The global ADC market is booming, projected to surpass $16 billion in 2025 and grow steadily through 2035. Innovations in linker technology, payload design, and AI‑driven antibody optimization are accelerating breakthroughs and expanding therapeutic possibilities.
Our Wilmington facility is designed to meet the growing demand for high‑potency manufacturing, ensure supply‑chain resilience, and support the next wave of ADC launches. Importantly, this site will support both drug substance conjugation and drug product. 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.
Manufacturing Associate Director, Drug Substance We invite you to become a part of our journey as the Manufacturing Associate Director, Drug Substance. This role offers you the chance to contribute to the site’s development and ensure successful GMP manufacturing. In this position the Manufacturing Associate Director will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS&T the Manufacturing Associate Director will provide comprehensive manufacturing and technical leadership to the DS organization. This position will continue within the role from design through operation of the facility.
Responsibilities
Lead and engage with the engineering design firm 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 and revision of technical documents including manufacturing batch records, SOPs and technical memos.
Provide Manufacturing and Technical expertise within the manufacturing team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing.
Support technical deliverables within Drug Substance to support the successful product launch.
Provide manufacturing and technical support for RFT implementation and execution.
Explain complex technical issues to external customers / agencies.
What skills you will need:
Bachelor’s degree in engineering, science or related discipline.
Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience.
Start‑up experience in a large‑scale commercial drug product facility highly desirable.
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.
Experience with 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.
Ability to adapt to changing priorities as project demands change.
Demonstrated skills in planning, communication (oral and written) and technical writing.
Required Skills
Adaptability
Adaptability
Antibody Drug Conjugates (ADC)
Aseptic Processing
Column Chromatography
Communication
Cross‑Cultural Awareness
Customer‑Focused
Driving Continuous Improvement
Engineering Design
Freeze Drying
GMP Compliance
Leadership
Lean Six Sigma Process Improvement
Management Process
Manufacturing
Manufacturing Quality Control
Manufacturing Support
Pharmaceutical Microbiology
Process Hazard Analysis (PHA)
Process Improvements
Production Management
Quality Management
Regulatory Compliance
Risk Based Approach
Preferred Skills
Current Employees apply
Contingent Workers apply
US and Puerto Rico Residents Only
Equal Employment Opportunity Statement 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.
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 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.
Salary and Benefits Salary range: $126,500 – $199,100. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Application Information Application deadline for this position is stated on this posting. If you are a current employee, you can apply through the Workday Jobs Hub. Qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance will be considered. The application deadline for this position is stated on this posting.
Work and Travel Travel required: 25% flexible work arrangements. Valid driving license required.
Additional Notes Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, 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 will be deemed the sole property of our company.
Job posting end date: 11/29/2025. A job posting is effective until 11:59:59 PM 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.
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ADC’s represent one of the most exciting frontiers in biopharmaceuticals today. By combining the targeting power of monoclonal antibodies with the potency of cytotoxic drugs, ADCs deliver cancer‑killing agents directly to tumor cells, minimizing damage to healthy tissue. This precision has revolutionized treatment for hematologic malignancies and is rapidly expanding into other cancers. The global ADC market is booming, projected to surpass $16 billion in 2025 and grow steadily through 2035. Innovations in linker technology, payload design, and AI‑driven antibody optimization are accelerating breakthroughs and expanding therapeutic possibilities.
Our Wilmington facility is designed to meet the growing demand for high‑potency manufacturing, ensure supply‑chain resilience, and support the next wave of ADC launches. Importantly, this site will support both drug substance conjugation and drug product. 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.
Manufacturing Associate Director, Drug Substance We invite you to become a part of our journey as the Manufacturing Associate Director, Drug Substance. This role offers you the chance to contribute to the site’s development and ensure successful GMP manufacturing. In this position the Manufacturing Associate Director will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS&T the Manufacturing Associate Director will provide comprehensive manufacturing and technical leadership to the DS organization. This position will continue within the role from design through operation of the facility.
Responsibilities
Lead and engage with the engineering design firm 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 and revision of technical documents including manufacturing batch records, SOPs and technical memos.
Provide Manufacturing and Technical expertise within the manufacturing team, including areas such as conjugation, chromatography, tangential flow filtration and filling.
Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing.
Support technical deliverables within Drug Substance to support the successful product launch.
Provide manufacturing and technical support for RFT implementation and execution.
Explain complex technical issues to external customers / agencies.
What skills you will need:
Bachelor’s degree in engineering, science or related discipline.
Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility.
Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience.
Start‑up experience in a large‑scale commercial drug product facility highly desirable.
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.
Experience with 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.
Ability to adapt to changing priorities as project demands change.
Demonstrated skills in planning, communication (oral and written) and technical writing.
Required Skills
Adaptability
Adaptability
Antibody Drug Conjugates (ADC)
Aseptic Processing
Column Chromatography
Communication
Cross‑Cultural Awareness
Customer‑Focused
Driving Continuous Improvement
Engineering Design
Freeze Drying
GMP Compliance
Leadership
Lean Six Sigma Process Improvement
Management Process
Manufacturing
Manufacturing Quality Control
Manufacturing Support
Pharmaceutical Microbiology
Process Hazard Analysis (PHA)
Process Improvements
Production Management
Quality Management
Regulatory Compliance
Risk Based Approach
Preferred Skills
Current Employees apply
Contingent Workers apply
US and Puerto Rico Residents Only
Equal Employment Opportunity Statement 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.
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 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.
Salary and Benefits Salary range: $126,500 – $199,100. Eligible for annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
Application Information Application deadline for this position is stated on this posting. If you are a current employee, you can apply through the Workday Jobs Hub. Qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance will be considered. The application deadline for this position is stated on this posting.
Work and Travel Travel required: 25% flexible work arrangements. Valid driving license required.
Additional Notes Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, 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 will be deemed the sole property of our company.
Job posting end date: 11/29/2025. A job posting is effective until 11:59:59 PM 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.
MSD
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