Senior Director, Manufacturing Sciences – Technologies

🔥 43 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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ADC Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

ADC Therapeutics is a commercial-stage global pioneer in the field of antibody drug conjugates (ADCs). The company focuses on transforming the lives of those impacted by cancer through a robust ADC portfolio targeting hematology and solid tumors. Their capabilities include a validated technology platform and a growing research & development toolbox, resulting in an approved product, ZYNLONTA®, for treating diffuse large B-cell lymphoma. Founded in 2011 and based in Lausanne, Switzerland, with operations in London and New Jersey, ADC Therapeutics is committed to confronting cancer and advancing treatment paradigms.

📋 Description

• Lead and develop the MSAT function covering ADC end-to-end manufacturing across clinical and commercial stages • Define MSAT strategy for external manufacturing aligned with corporate objectives • Develop and mentor a high-performing MSAT team with expertise in biologics, highly potent payloads, and aseptic operations • Serve as a key member of the Operations Management Team on long-term supply, risk mitigation, and operational excellence • Own manufacturing process stewardship and process knowledge management across ADCT and CDMO partners • Partner with Quality and Supply Chain to manage CDMO performance • Oversee MSAT activities at CDMOs, process characterization, validation (PPQ), process monitoring, and CPV programs • Ensure consistent process understanding and control across global manufacturing partners • Drive resolution of manufacturing deviations, CAPAs, and change requests • Support CDMO selection, technical due diligence, and onboarding • Provide scientific and technical oversight across the full ADC manufacturing lifecycle • Assess and implement post-approval changes, comparability strategies, and process optimization • Oversee process improvements to enhance robustness, yield, cost, and supply reliability • Serve as senior-level MSAT lead for regulatory submissions and inspections, including INDs, BLAs, MAAs, and supplements • Author, review, and approve CMC regulatory sections and responses • Support health authority inspections and technical audits of CDMOs • Partner with Quality to ensure compliance with cGMP, ICH, and global regulatory expectations • Ensure scientific justifications for process control strategies, specifications, and lifecycle changes • Collaborate with Quality Assurance, Quality Control, Supply Chain, and CMC Regulatory • Provide MSAT input into development programs, commercial readiness, and long-range supply planning • Participate in governance forums, change control boards, and technical review committees • Establish and track critical process parameters and CPV metrics • Identify and mitigate technical and operational risks within the external manufacturing network • Drive lessons learned, standardization, and continuous improvement across CDMOs and Production Management Teams

🎯 Requirements

• Advanced degree (MS or PhD) in Biochemistry, Chemical Engineering, Biotechnology, or related field; BS with significant industry experience considered • 12+ years of relevant experience including biologics manufacturing, CMC operations, and CDMO management • Extensive experience in commercial GMP manufacturing operations, process validation, CPV, and regulatory submission preparation • Strong scientific problem-solving and root-cause analysis skills • Proven ability to lead through influence in external or remote environments • Excellent communication skills for executive, regulatory, and partner interfaces • Strategic thinker with strong execution focus • Comfortable operating in a fast-paced, commercial-stage organization • Deep knowledge of bioconjugate technologies preferred, including antibody, high potency linker-payload, conjugation, aseptic fill, and lyophilization • Strong track record of building and leading technical and cross-functional teams • Visionary leadership with a strategic mindset • High standards of excellence, urgency, and accountability • Collaborative, team-oriented approach • Strong organizational and critical thinking skills • Ability to mentor, influence, and drive change across a remote organization • Willingness to undertake domestic and international travel up to 20%, primarily to CDMOs

🏖️ Benefits

• Competitive biotech base salary • Annual target bonus (eligibility based on company performance) • New hire stock options • Medical, Dental and Vision benefits starting on the 1st day of employment • 401(k) with company match • Paid time off and company holidays, including a company-wide shutdown at the end of the year • Paid Parental Leave • Life and Disability Insurance • Tax-advantaged health savings and spending accounts • Flexible work environment • Hands-on, collaborative culture • Mission-driven work that puts patients first

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