The posting
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!
