Senior Process Engineer, Tech Transfer & Manufacturing Readiness

The posting, as LOTTE BIOLOGICS USA, LLC wrote it

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 Senior Process Engineer is a key technical leader responsible for supporting the successful transfer, fit assessment, and lifecycle optimization of monoclonal antibody (mAb) and antibody-drug conjugate (ADC) processes within a CDMO manufacturing environment. This role partners closely with MS&T, Plant/Facilities Engineering, and Capital Project Engineering to ensure manufacturing readiness, effective facility fit, and robust process performance.

The position requires deep expertise in bioprocessing operations and a strong understanding of equipment design, facility capabilities, and capital project execution to enable seamless delivery of client programs from tech transfer through commercial manufacturing.

This role directly enables

• Successful onboarding of new client programs
• Efficient capital deployment and facility utilization
• Robust, scalable, and compliant manufacturing processes

Duties & Responsibilities

• Serve as the senior process engineering technical owner for assigned client programs, manufacturing platforms, unit operations, and process-related equipment, maintaining accountability from proposal and facility-fit assessment through technology transfer, PPQ, commercial manufacturing, and lifecycle improvement.
• Exercise expert-level, independent engineering judgment to make timely, risk-based decisions involving process design, scale-up, equipment capability, utility demand, containment, control strategy, manufacturability, and GMP compliance; clearly document assumptions, rationale, risks, and required escalation.
• Lead complex, cross-functional technical problem solving across MS&T, Manufacturing, Quality, Facilities and Plant Engineering, Automation, Capital Projects, EHS, Supply Chain, Validation, and client teams; establish problem statements, align decision criteria, direct root-cause analysis, and drive durable solutions to closure.
• Lead facility-fit and manufacturing-readiness assessments for mAb and ADC processes, evaluating process requirements against equipment, single-use assemblies, automation, clean utilities, HVAC, material and personnel flows, capacity, and high-potency containment constraints.
• Translate client process knowledge and product requirements into robust engineering bases of design, process descriptions, flow diagrams, mass and energy balances, equipment sizing, utility loads, URS, control requirements, acceptance criteria, and operational-readiness plans.
• Own technical gap assessments and solution strategies, integrating product quality, pat

[…]
ovement activities in a fast-paced, multi-client CDMO environment.

• Ability to translate process and client requirements into engineering deliverables and support capital projects from design and vendor selection through FAT/SAT, commissioning, qualification, startup, operational readiness, and turnover.
• Strong client-facing communication, stakeholder influence, automation and data-systems awareness, audit and inspection support, and leadership skills, including mentoring, peer review, knowledge sharing, and development of repeatable engineering standards.

Physical Demands

• The physical demands of this position may include independently lifting and carrying items weighing up to 50 pounds; sitting, standing, walking on level surfaces, crouching, squatting, kneeling, and crawling; climbing stairs and ladders; and performing visual inspections of equipment and installations. The role also requires the use of applicable personal protective equipment (PPE), including a hard hat, hearing protection, safety glasses, steel-toed footwear, fall-protection equipment, and electrical-safety gear.

Work Environment

• The work environment may include office, laboratory, indoor, and outdoor settings. The position may require working independently or in proximity to others and may involve exposure to elevated noise levels, work at heights, and access to confined or restricted spaces.

Travel

This role may require up to 10% travel.

Target Bonus

16%

Work Location

East Syracuse, NY
New York Pay Range
$110,000 — $154,000 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!