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About the Role

The Senior Engineer, ADC Manufacturing serves as a technical subject matter expert for antibody drug conjugate (ADC) manufacturing processes, driving process robustness, investigating deviations, and ensuring cGMP compliance. This role requires hands-on technical skills and strategic influence across cross-functional teams.

Responsibilities

Serve as the primary technical authority for ADC conjugation, formulation, and purification processes.
Lead technical transfers of ADC processes for First in Human, scale up, late-stage, and Validation activities.
Support a high-performing technical team through communication and mentoring.
Develop and maintain process descriptions, process flow diagrams, and process models.
Act as a liaison between Manufacturing and HSE for handling high toxicity compounds and oversee manufacturing safety.
Own and improve key unit operations (e.g., TFF, chromatography, conjugation reactions, solvent handling, Buffer Preparations).
Collaborate with Automation, MSAT, HSE, and Facilities to achieve site manufacturing deliverables.
Communicate and work with internal teams and clients to resolve on-the-floor issues and document revisions.
Support real-time on-the-floor support to manufacturing teams during batch execution.
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.
Serve as SME during audits and regulatory inspections.
Evaluate and implement new technologies, raw materials, equipment, and methods.
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.
Provide technical justification for changes using risk-based methodologies.

Requirements

Bachelor’s degree in Chemical Engineering, Chemistry, Biology or related field required.
Advanced degree (MS/PhD) preferred.
7+ years of experience in biopharmaceutical MSAT, Process Engineering, or Manufacturing Sciences required.
2–4 years of experience specifically in ADCs or complex bioconjugation processes strongly preferred.
Hands-on experience with cGMP clinical or commercial manufacturing.
Proven success in working in teams within a matrixed environment.
Demonstrated success in tech transfers and process scale up.
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).
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).

Skills

Technical understanding of conjugation chemistries (e.g., maleimide thiol, enzymatic, site specific).
Technical understanding of purification technologies (TFF, chromatography).
Experience handling highly potency drug linkers, highly potent active pharmaceutical ingredients (HPAPIs) and knowledge of Occupational Health Category (OHC) classifications.
Knowledge of 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 skills.
Strong technical writing skills.
Strong problem-solving abilities.
Meeting facilitation skills.
Ability to conduct technical discussions and achieve alignment across teams and clients.
Ability to operate effectively in a fast-paced, cross-functional team environment.
Ability to mentor junior engineers and manufacturing personnel.

Location

East Syracuse, NY

Work Type

Full-time

Experience Level

Senior

Education Level

Bachelor's degree in Chemical Engineering, Chemistry, Biology or related field
MS/PhD preferred

Salary/Compensations

$91,000—$142,000 USD

Benefits

16% Target Bonus

About the Company

LOTTE BIOLOGICS is delivering therapies that enable a healthier world.
A new company, built on 80 years of tradition.
Embody core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives.
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.

Equal Opportunity

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!