--- title: 'Senior Engineer, Bioconjugation Operations at LOTTE BIOLOGICS USA, LLC' canonical: 'https://feeny.ai/job/senior-engineer-bioconjugation-operations-lotte-biologics-usa-llc-syracuse-ctsmqvwv2wr8' type: 'job' last_seen: '2026-10-28' --- # Senior Engineer, Bioconjugation Operations at LOTTE BIOLOGICS USA, LLC - **Company:** LOTTE BIOLOGICS USA, LLC - **Location:** Syracuse, NY - **Compensation:** $91k–$142k - **Posted:** 2026-03-27 - **Last confirmed live:** 2026-10-28 - **Apply:** https://job-boards.greenhouse.io/lottebiologicsusallc/jobs/5160917008 ## Job description 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 Engineer, Bioconjugation Operations serves as a technical subject matter expert (SME) supporting bioconjugation, ADC, and related manufacturing processes across clinical and commercial programs. This role provides expertise in bioconjugation chemistry, antibody purification, process engineering, technology transfer, scale-up manufacturing, process optimization, and cGMP operations. The Senior Engineer drives and supports process deviation investigations, implements process improvements, and ensures manufacturing operations are compliant with cGMP standards. The ideal candidate combines strong hands-on technical expertise with the ability to influence cross-functional teams, identify and implement best practices, and deliver technical training to support operational excellence. Duties & Responsibilities Technical Leadership - Serves as technical SME for bioconjugation and ADC manufacturing processes, including conjugation, formulation, and purification, across multiple development stages. - Leads technology transfer and scale-up activities for bioconjugation and ADC processes supporting First-in-Human, late-stage, validation, and commercial manufacturing readiness. - Provides technical leadership through effective communication, knowledge sharing, and mentoring of junior engineers and manufacturing personnel. - Develops and maintains process descriptions, process flow diagrams, and process models. - Acts as a liaison between Manufacturing and HSE team for the handling of High toxicity compounds and oversees safety of manufacturing activities. - Owns and improves key unit operations (e.g., TFF, chromatography, conjugation reactions, formulation, solvent handling, and buffer preparation). - Collaborates with cross-functional teams, including Manufacturing, MSAT, Automation, HSE, Facilities, and external clients to achieve production and operational objectives. - Communicates and works with internal teams and clients to resolve manufacturing issues, support document revisions, and ensure successful process execution. - Provides real-time floor support to manufacturing teams during batch execution as needed. - Leads investigations, root cause analysis, and CAPA development for OOS, OOT, and deviations. - Assesses process performance trends using statistical tools and identify process improvement opportunities for manufacturing robustness. - Serves as SME during audits, including regulatory inspections. - Evaluates and implement new technologies, raw materials, equipment, and methods to enhance process performance and safety. - Partners with Quality Assurance, Quality Control, Supply Chain, Process Development, and Facilities to support seamless operations. - Supports successful introduction of new products and technologies into manufacturing through process readiness assessments, risk evaluations, and cross-functional planning activities. Documentation & Technical Writing - Author and review technology transfer documentation, equipment fit-gap assessments, batch records, and process support documentation. - Author and review master batch records (MBRs), SOPs, technical protocols and reports - Support Regulatory agency responses for continued regulatory compliance and filing content (IND/IMPDs, BLAs). - Provide technical justification for changes using risk-based methodologies (FMEA, QbD principles). Education & Experience - Bachelor’s degree in Chemical Engineering, Chemistry, Biology or related field required. - Advanced degree (MS/PhD) preferred. - 7+ years of experience in biopharmaceutical manufacturing, process engineering, MSAT, technology transfer or manufacturing sciences is required. Experience with ADCs, bioconjugation processes, HPAPIs, or related complex manufacturing technologies is strongly preferred. - Hands on experience with cGMP clinical or commercial manufacturing. - Proven success in working in teams within a matrixed environment. - Demonstrated success in with technology transfers and process scale up activities. Knowledge, Skills, Abilities Technical Abilities Technical understanding of: - Conjugation chemistries (e.g., maleimide thiol, enzymatic, site specific) - Purification technologies (TFF, chromatography) - Experience handling high-potency drug linkers, highly potent active pharmaceutical ingredients (HPAPIs) and knowledge of Occupational Health Category (OHC) classifications. - cGMP and regulatory expectations - Competency with Data analysis tools (e.g., JMP), DOE and multivariate analysis for process performance evaluations. - Familiarity of regulatory issues pertaining to the manufacture of ADCs, large scale biopharmaceutical unit operations and process validations. - Ability to interpret engineering drawings, P&IDs, and equipment manuals. - Ability to perform risk assessments and apply QbD principles to technical decisions. - Ability to lead cross functional technical investigations to closure. Interpersonal/Leadership Abilities - Strong verbal communication, technical writing skills and problem-solving abilities. - Meeting facilitation, technical discussions and alignment across teams and clients. - Ability to operate effectively in a fast-paced, cross-functional team environment. - Work with and mentor junior engineers and manufacturing personnel. Physical Demands - Lift up to 50 lbs unassisted and perform physical activities such as crouching, kneeling, crawling, climbing stairs and ladders, and walking on level surfaces. - Perform visual inspections of installations and equipment. - On the floor monitoring (if necessary) while using appropriate personal protective equipment (PPE) or Powdered Air Purifying Respirator (PAPR), If necessary. - Ability to work in classified clean-room environments (e.g., ISO8), requiring gowning procedures. - Ability to work around hazardous chemicals, solvents, and high potency compounds while following appropriate control strategies. - Ability to move equipment or materials using carts or similar devices (if applicable). Work Environment - Work is performed in office and supporting on the floor monitoring (if necessary) while in the controlled manufacturing areas. - May involve exposure to chemical odors, solvents, and high potency materials under controlled conditions. - Work may involve proximity to moving mechanical equipment and standard manufacturing utilities. Supervisory Responsibilities This is a senior individual contributor role with technical leadership responsibilities but no direct people management. Travel <5% travel required for this role. Target Bonus 16% Work Location: East Syracuse, NY New York Pay Range $91,000—$142,000 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! ## About LOTTE BIOLOGICS USA, LLC ## Company Overview - **One-liner**: LOTTE BIOLOGICS is a global Contract Development and Manufacturing Organization (CDMO) focused on end-to-end biopharmaceutical antibody production, dedicated to becoming the most trusted partner in the industry. - **Entity Type**: Private (Subsidiary of LOTTE Group, a large South Korean conglomerate) - **Headquarters**: Seoul, South Korea (Parent entity); Syracuse, NY, USA (Primary US operational campus) - **Founded**: 2022 - **Founders**: Established as a subsidiary of LOTTE Group ## Core Business - **Primary industry/industries**: Biopharmaceutical Contract Development and Manufacturing (CDMO); Biotechnology - **Target customers**: Pharmaceutical and biotechnology companies (B2B, Enterprise) needing outsourced development and cGMP manufacturing of biologic drug substances, including antibodies and antibody-drug conjugates (ADCs). - **Mission or purpose statement**: Dedicated to improving the lives of patients worldwide as a leading global CDMO. The company aims to deliver therapies that enable a healthier world. ## Products & Services - **Contract Development Organization (CDO)**: Development service capabilities across the product life cycle, including product launches, scale-down process verification, and technology transfers. - **Contract Manufacturing Organization (CMO)**: cGMP manufacturing services for the clinical and commercial supply of biological Drug Substance. The Syracuse Bio Campus has 40,000 liters of manufacturing capacity with 8x 5,000L stainless steel bioreactors. - **Analytical Testing Services**: Quality control testing including analytical tech transfer, in-process testing, finished product testing, and stability testing. The site is equipped with HPLC, UPLC, mass spectrometers, PCR systems, and automated ELISA systems. - **ADC Service**: Conjugation of Antibody-Drug Conjugates (ADCs), combining the specificity of monoclonal antibodies with the potency of small-molecule drugs using stable linkers. - **Drug Substance Storage**: On-site cell bank facility and cryogenic storage of drug substance with capacity for 5,460 x 10L bottles in a dedicated cryogenic storage building. ## Market Standing - **Valuation/Market Cap**: Not publicly available (private subsidiary of LOTTE Group) - **Key Metric**: Major capital investment underway with a 360,000L bio campus under construction in Songdo, Incheon, South Korea (operations beginning 2027), complementing the 40,000L Syracuse campus. The parent LOTTE Group is one of the largest conglomerates in Korea with operations in 30+ countries. - **Notable Investors/Partners**: LOTTE Group (parent company with businesses in petro/fine chemicals, food, retail, hotels, construction, and IT). Regulatory compliance track record includes 62+ approvals by health authorities worldwide including FDA, EMA, PMDA, and MFDS. - **Growth Signals**: Rapid expansion with a "two-track strategy of acquiring and building." The Songdo Bio Campus will add 120,000L of capacity at its first facility with plans for a total of 360,000L. The company describes itself as having a "start-up spirit" combined with the backing of a major global conglomerate. ## Competitive Advantages - **End-to-end capabilities**: Offers full lifecycle support from development through clinical and commercial production, including unique ADC conjugation services. - **Conglomerate backing**: As part of LOTTE Group (established 1948, operating in 30+ countries), the company has deep financial resources, global supply chain access, and long-term strategic stability. - **Proven regulatory track record**: With 62+ global health authority approvals, the company demonstrates mature quality systems and regulatory expertise. - **Dual-campus strategy**: Operations in both the US (Syracuse, NY) and South Korea (Songdo, Incheon) provide geographic diversification and access to two major biotech markets. - **State-of-the-art facilities**: Syracuse campus features 8 x 5,000L stainless steel bioreactors, 3 inoculation suites, 2 purification suites, and advanced analytical equipment for concurrent manufacturing of multiple products. ## Strategic Focus - **Capacity expansion**: Major focus on constructing the Songdo Bio Campus in South Korea to add significant manufacturing capacity (up to 360,000L total). - **Technology investment**: Emphasis on sustainable clean energy, automation, artificial intelligence, and quality systems to meet global manufacturing standards. - **Talent development**: Commitment to fostering talent and offering secure, fulfilling career paths as the company scales. - **Quality leadership**: Priority on maintaining the highest standards of quality and regulatory compliance to serve as a trusted partner for clients. - **Patient-centric approach**: Focus on improving patient outcomes and making a positive impact on global quality of life. ## Why Work Here - **Start-up spirit with big-company backing**: The company describes itself as having a "start-up spirit" and "passion for quality manufacturing," combined with the resources and stability of being part of the LOTTE Group, a major global conglomerate. - **Growth opportunities**: With a new 360,000L bio campus under construction and rapid expansion, there are significant career growth opportunities for professionals joining at this early stage. - **Mission-driven work**: Employees contribute directly to delivering therapies that enable a healthier world, with a focus on improving patient outcomes globally. - **Work environment**: The company emphasizes "Enriching the lives of its diverse workforce and their families" through a secure work environment where individual rights are respected. Core values include being inspired by science, embracing diversity, fostering talent, and connecting lives. - **Location**: Syracuse, NY campus at 6000 Thompson Rd, East Syracuse, NY 13057. The facility includes robust manufacturing support services onsite including MS&T, procurement, quality assurance, engineering, and enabling functions like HR and finance. - **Benefits**: The company offers a "highly competitive and comprehensive benefits package" [greenhouse.io](https://job-boards.greenhouse.io/lottebiologicsusallc). - **Current opportunities**: Active hiring in Syracuse, NY for roles including Principal Scientist (ADC Bioconjugation), Sr. Scientist (Analytical Sciences & Technology), Facilities Engineer, Plant Engineer, Senior Project Engineer, Senior Engineer (ADC Manufacturing), Sr. Project Manager (PMO), Senior Specialist (Computer System Validation), and Associate Director (HR Operations) [greenhouse.io](https://job-boards.greenhouse.io/lottebiologicsusallc). ## Sources 1. [LOTTE BIOLOGICS - Company About Page](https://www.lottebiologics.com/en/aboutus/company) 2. [LOTTE BIOLOGICS - Syracuse Bio Campus Page](https://www.lottebiologics.com/en/aboutus/syracuse) 3. [LOTTE BIOLOGICS - Main Website](https://www.lottebiologics.com/en) 4. [Greenhouse Careers Page - LOTTE BIOLOGICS USA, LLC](https://job-boards.greenhouse.io/lottebiologicsusallc) ## Other roles at LOTTE BIOLOGICS USA, LLC - [HR Associate III (Payroll & Benefits)](https://feeny.ai/job/hr-associate-iii-payroll-benefits-lotte-biologics-usa-llc-syracuse-1jhmy2sdprta) — Syracuse, NY - [Sr. Manager, Data and Analytics](https://feeny.ai/job/sr-manager-data-and-analytics-lotte-biologics-usa-llc-syracuse-pn20qk6rwwmp) — Syracuse, NY - [Sr. Manager, QA Program Lead](https://feeny.ai/job/sr-manager-qa-program-lead-lotte-biologics-usa-llc-syracuse-1zvxmm2tjans) — Syracuse, NY - [Associate Automation Engineer](https://feeny.ai/job/associate-automation-engineer-lotte-biologics-usa-llc-syracuse-93q5w7d4had3) — Syracuse, NY - [Senior Process Engineer, Tech Transfer & Manufacturing Readiness](https://feeny.ai/job/senior-process-engineer-tech-transfer-manufacturing-readiness-lotte-biologics-wx3d76bz40h6) — Syracuse, NY - [Senior Engineering Project Manager (Facilities & Capital Projects)](https://feeny.ai/job/senior-engineering-project-manager-facilities-capital-projects-lotte-biologics-enc0cztj05va) — Syracuse, NY - [EHS Manager](https://feeny.ai/job/ehs-manager-lotte-biologics-usa-llc-syracuse-sgyjqwdv2bt0) — Syracuse, NY - [Senior Project Manager, Project Management Office (PMO)](https://feeny.ai/job/senior-project-manager-project-management-office-pmo-lotte-biologics-usa-llc-4zx06td98mn2) — Syracuse, NY