LOTTE BIOLOGICS USA, LLC
Senior Engineer, ADC Manufacturing
Syracuse, NY · Senior
Sponsorship not specified$91k-$142kDetected 104 days ago
Data AnalysisComplianceSupply ChainProcess ImprovementGMPLeadershipCommunicationProblem SolvingMentoringWriting
About the role
- 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 ideal candidate combines hands-on technical skills with strategic influence across cross-functional teams, will identify best practices and provide technical trainings.
Responsibilities
- Leads technical transfers of ADC processes for First in Human, scale up, late-stage, Validation activities and design of Critical Process Parameter readiness.
- Own and improve key unit operations (e.g., TFF, chromatography, conjugation reactions, solvent handling and Buffer Preparations).
- Supports real time-on-the-floor support to manufacturing teams during batch execution as necessary.
- Partner with Quality Assurance, Quality Control, Supply Chain, Process Development, and Facilities to support seamless operations.
- Support Regulatory agency responses for continued regulatory compliance and filing content (IND/IMPDs, BLAs).
- Ability to perform risk assessments and apply QbD principles to technical decisions.
- Ability to lead cross functional technical investigations to closure.
- Perform visual inspections of installations and equipment.
Requirements
- Bachelor's degree in Chemical Engineering, Chemistry, Biology or related field required.
- Hands on experience with cGMP clinical or commercial manufacturing.
- 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).
Nice to have
- Serves as the primary technical authority for ADC conjugation, formulation, and purification processes across multiple development stages.
- Act as a liaison between Manufacturing and HSE team for the handling of High toxicity compounds and oversees safety of manufacturing activities.
- Serve as SME during audits, including regulatory inspections.
Skills
- Assess process performance trends using statistical tools and identify process improvement opportunities for manufacturing robustness.
Compensation
- East Syracuse, NY
- New York Pay Range
- $91,000 - $142,000 USD
- 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!
Benefits
- Experience handling highly potency drug linkers, highly potent active pharmaceutical ingredients (HPAPIs) and knowledge of Occupational Health Category (OHC) classifications.
Company info
- We are an Equal Employment Opportunity ("EEO") Employer.
- Collaborate with partners and customers, such as Automation, MSAT, HSE and Facilities to achieve site manufacturing deliverables for manufacturing production.
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