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.

Duties & Responsibilities

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.

Education & Experience

BS or MS degree in Biotechnology, Biochemical Engineering, Biochemistry, or related Life Science discipline with 10+ years of industry experience is required.

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.

Knowledge, Skills, Abilities

Experience with common downstream unit operations such as tangential flow filtration, dead-end filtration, and protein chromatography.

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.

Experience leading in a customer-facing, project-driven CDMO environment is highly desirable.

Proven ability to coach, mentor, and develop team members.

Physical Demands

Regularly required to wear extensive gowning, including sterile coveralls, gloves, goggles, face shields, and respirators, in classified cleanroom and containment environments.

Ability to stand or walk for extended periods while overseeing operations on the manufacturing floor.

Infrequent unassisted lifting (up to 50 lbs.).

Role supports the potential of 24/7 operations but is not shift-based; occasional off-hour presence may be required to support manufacturing needs or critical events.

Work Environment

Position operates within a high-containment ADC manufacturing facility with controlled environments (ISO-classified cleanrooms).

Frequent entry into suites where hazardous and potent materials are handled, requiring adherence to strict safety and gowning protocols.

Work involves exposure to chemicals such as acids, caustics, solvents, and high-potency compounds, as well as high-temperature liquids and steam.

Appropriate PPE and aseptic techniques are mandatory to ensure personal and product safety.

Office and conference work is conducted in adjacent unclassified areas.

Supervisory Responsibilities

Will supervise a direct staff of 4-10 employees with department level managerial responsibilities.

Travel

The role may involve domestic and international travel, as required by business needs.

Target Bonus

18%

Work Location:

East Syracuse, NY

New York Pay Range

$128,000 - $179,000 USD

We are an Equal Employment Opportunity ("EEO") Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!? If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!

Lotte Biologics USA LLC

Latest Jobs

Associate Director, ADC Manufacturing Operations