Associate Director, ADC Manufacturing Operations

Lotte Biologics Usa-posted 13 days ago
$128,000 - $179,000/Yr
Full-time • Manager
Onsite • Syracuse, NY
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We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World . A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science , Embracing Diversity , Fostering Talent , and Connecting Lives . Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. Position Summary The Associate Director of Antibody Drug Conjugate (ADC) Manufacturing Operations is responsible for the oversight of all manufacturing operations within the mAb reduction, conjugation, and drug substance filling suites. Operating as a Contract Development and Manufacturing Organization (CDMO), this facility provides manufacturing services to external customers and internal programs, and the Associate Director will play a critical role in delivering high-quality, compliant, and timely production. This individual will work in a collaborative, team-driven environment, ensuring smooth transfer of customer projects to GMP manufacturing. This role will lead process optimization, organizational development, and customer-facing operational strategies. This role is accountable for fostering a culture of safety, quality, efficiency, and continuous improvement, while actively engaging with clients and cross-functional teams to meet production goals.

  • Oversee all ADC manufacturing operations within the CDMO facilities, collaborating with partners and customers, including: HSE, QA, F&E, Development (PD, MS&T, AS&T), to achieve manufacturing deliverables, such as yield optimization, COGs reduction, lean manufacturing, schedule adherence, and facility enhancements.
  • Provide coaching, mentoring, and professional development for manufacturing staff; regularly review performance, establish objectives and support succession planning.
  • Lead and manage project plans, budgets, personnel, and schedules for manufacturing and client-specific projects, ensuring alignment with CDMO deliverables and customer expectations.
  • Support tech transfer and manufacturing of ADCs and other bioconjugates for external clients, including material planning, batch record preparation, training, troubleshooting and deviation handling.
  • Lead commissioning, qualification and start-up activities (FAT/SAT/IQ/OQ/PQ), including protocol development, execution, troubleshooting, and change control, following cGMP and client-specific requirements.
  • Drive strong collaboration and communication across Manufacturing, Quality, Development (MS&T, AS&T, PD), and Product teams to ensure projects meet all timelines and client commitments.
  • Develop and lead a high-performance management team, directing recruitment, staffing and development of manufacturing personnel.
  • Invest in leadership development for current and future leaders through coaching, mentoring, and recognition programs.
  • Define and communicate operational strategy and objectives for the facility to meet site, corporate, and CDMO client goals.
  • Establish high performance and compliance standards aligned with regulatory requirements (FDA, EMA, etc.) and biologics manufacturing best practices.
  • Contribute to the development of the annual operating budget, manage resources to achieve financial objectives, and monitor operational performance.
  • Provide support for client audits, regulatory inspections, and risk assessments, ensuring CDMO and GMP compliance.
  • Stay current with emerging technologies, scientific advancements, and regulatory trends relevant to ADC manufacturing and CDMO operations.
  • BS or MS degree in Biotechnology, Biochemical Engineering, Biochemistry, or related Life Science discipline with 10+ years of industry experience is required.
  • Strong working knowledge of cGMP practices, FDA/EMA compliance, OSHA requirements, and CDMO operational standards.
  • Proven leadership skills with a track record of managing both direct reports and cross-functional teams in a matrix environment.
  • Excellent verbal communication, documentation, and technical writing skills.
  • Demonstrated problem-solving skills under resource constraints and time pressure.
  • Proven ability to coach, mentor, and develop team members.
  • PhD in a relevant field (e.g., chemistry, organic chemistry) may be considered as equivalent experience.
  • Experience in Antibody Drug Conjugation within biotech/biopharma or CDMO operations is highly desirable.
  • Experience with common downstream unit operations such as tangential flow filtration, dead-end filtration, and protein chromatography.
  • Experience leading in a customer-facing, project-driven CDMO environment is highly desirable.
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