Associate Director, Drug Substance Operations - Wilmington Biotech at Merck Sharp & Dohme Corp. /Netherlands

, , United States -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

199100.0

Posted On

15 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Adaptability, Antibody Drug Conjugates (ADC), Aseptic Processing, Column Chromatography, Communication, Driving Continuous Improvement, Engineering Design, GMP Compliance, Leadership, Lean Six Sigma Process Improvement, Manufacturing, Manufacturing Quality Control, Quality Management, Regulatory Compliance, Risk Based Approach

Industry

Pharmaceutical Manufacturing

Description

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. 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 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. 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. 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: 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 {+ 5 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: 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 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 https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (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: No relocation VISA Sponsorship: Yes Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/29/2025 *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. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Responsibilities

The Manufacturing Associate Director will ensure smooth operation of various aspects of manufacturing and provide comprehensive manufacturing and technical leadership to the Drug Substance organization. This role involves leading engineering design, process hazard analyses, and supporting equipment qualification deliverables.