Senior Engineer, ADC Manufacturing

LOTTE BIOLOGICS USA, LLC•Syracuse, NY

40d•$91,000 - $142,000•Onsite

About The Position

The Senior Engineer, ADC Manufacturing is an individual contributor that serves as a technical SME for antibody drug conjugate (ADC) manufacturing processes across clinical and commercial programs. This role provides subject matter expertise in conjugation chemistry, purification, scaleup, and technology transfer. The Senior Engineer drives process robustness, investigates deviations, implements process improvements, and ensures that manufacturing operations comply with cGMP standards. The ideal candidate combines hands-on technical skills with strategic influence across cross-functional teams, will identify best practices and provide technical trainings.

Requirements

Bachelor’s degree in Chemical Engineering, Chemistry, Biology or related field required.
7+ years of experience in biopharmaceutical MSAT, Process Engineering, or Manufacturing Sciences is required; 2–4 years of experience specifically in ADCs or complex bioconjugation processes 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 tech transfers, and process scale up.
Technical understanding of: Conjugation chemistries (e.g., maleimide thiol, enzymatic, site specific)
Purification technologies (TFF, chromatography)
Experience handling highly 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.
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.

Nice To Haves

Advanced degree (MS/PhD) preferred.
2–4 years of experience specifically in ADCs or complex bioconjugation processes is strongly preferred.

Responsibilities

Serves as the primary technical authority for ADC conjugation, formulation, and purification processes across multiple development stages.
Leads technical transfers of ADC processes for First in Human, scale up, late-stage, Validation activities and design of Critical Process Parameter readiness.
Supports a high-performing technical team through effective communication and mentoring of junior engineers.
Develops and maintains process descriptions, process flow diagrams, and process models.
Act as a liaison between Manufacturing and HSE team for the handling of High toxicity compounds and oversees safety of manufacturing activities.
Own and improve key unit operations (e.g., TFF, chromatography, conjugation reactions, solvent handling and Buffer Preparations).
Collaborate with partners and customers, such as Automation, MSAT, HSE and Facilities to achieve site manufacturing deliverables for manufacturing production.
Communicates and work with internal teams and clients to resolve on the floor issues, document revisions for successful process execution.
Supports real time-on-the-floor support to manufacturing teams during batch execution as necessary.
Lead investigations, root cause analysis, and CAPA development for OOS, OOT, and deviations.
Assess process performance trends using statistical tools and identify process improvement opportunities for manufacturing robustness.
Serve as SME during audits, including regulatory inspections.
Evaluate and implement new technologies, raw materials, equipment, and methods to enhance process performance and safety.
Partner with Quality Assurance, Quality Control, Supply Chain, Process Development, and Facilities to support seamless operations.
Author and review technology transfer documents, equipment fit gap assessments, and batch records.
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).