Senior Specialist, Drug Product Operations - Wilmington Biotech

Overview 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 Senior Specialist Drug Product. This role offers you the chance to contribute to the site's development and ensure successful GMP manufacturing. In this position the Manufacturing Senior Specialist will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS&T the Manufacturing Senior Specialist will provide comprehensive manufacturing and technical leadership to the drug product organization. Responsibilities Actively engage with the engineering design firm in detailed design on all aspects of the drug product manufacturing. Active participation in Process Hazard Analyses and Quality Risk Assessments as necessary. Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT). Execute automation sprints as necessary in the drug product area Support equipment qualification deliverables during execution of project phase 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 sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection (manual and automated). Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing. Support technical deliverables within Drug Product to support the successful product launch. Promote a Safety First, Quality Always mindset with Inclusion for all, fostering a Right First Time Culture. Provide technical support for RFT implementation and execution. Explain complex technical issues to external customers / agencies. Education Bachelor’s degree in engineering, science or related discipline. Required Experience And Skills Five or more (5+) 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. Ability to 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 placebo runs, developmental batches and PPQ runs. Experience with AVI/MVI and creation of library of defects. 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. Understanding of USP1790 and industry/ regulatory requirements such as Annex 1. Demonstrated skills in planning, communication (oral and written) and in particular technical writing. Skills Accountability Adaptability Analytical Problem Solving Antibody Drug Conjugates (ADC) Aseptic Manufacturing Biostatistics cGMP Compliance Communication Data Analysis Decision Making Engineering Design Engineering Mathematics Factory Acceptance Test (FAT) GMP Compliance Inventory Management Lean Six Sigma Continuous Improvement Manufacturing Manufacturing Technologies Personal Initiative Pediatric? (no) Benefits and Other Details 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. Requirements 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 $94,300.00 - $148,500.00. 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. #J-18808-Ljbffr Merck