Associate Director, Drug Substance Operations - Wilmington Biotech

Manufacturing Associate Director, Drug Substance

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, Delawarea bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. ADCs 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 jobit'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 treatmentone molecule at a time.

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 the 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.

Bring energy, knowledge, innovation to carry out the following :

• 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 :

To excel in this role, you will need :

Required Skills : 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 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 employees 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 (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.