Associate Scientist, Antibody Drug Conjugate (ADC) & Purification Development - LOTTE BIOLOGICS USA, LLC

Position Summary

The primary role of the Associate Scientist, ADC & Purification Development is to execute laboratory experiments in the development, optimization, characterization, scale-up, and technical process transfer of ADCs from laboratory to manufacturing scale using knowledge of conjugation chemistry and downstream unit operations.  The ADC Associate Scientist will also support the development laboratory start-up, while also providing on-floor GMP support of manufacturing.  Additionally, the ADC Associate Scientist will support documentation review, protocols, technical reports, change controls, and the CMC regulatory submissions under supervision.  The role is expected to follow detailed GLP/GMP procedures and safety requirements. 

Responsibilities

• Leverage an understanding of scale-down drug substance purification and bioconjugation processes to support ADC laboratory process development and process characterization through study execution and data analysis of purification and bioconjugation processes
• Support process optimization, process robustness initiatives, process troubleshooting, process yield improvements, and process-related investigations at manufacturing-scale through conducting scale-down studies of purification processes for antibodies and novel bioconjugation methodologies to improve ADCs and identify critical process parameters and process attributes
• Support process technical transfers from laboratory-scale or pilot-scale to manufacturing-scale of biologics and bioconjugation process development including ADCs
• Provide technical on-floor support for production of GMP antibody and ADC batches
• Document laboratory execution and results of experimental plans in laboratory notebooks, perform data verification, as well as author and review SOPs and downstream purification documentation to capture experimental designs and results via protocols and other associated scientific technical documents for process development, process characterization, as well as validation protocols with supervision
• Support continuous process improvements and advance technology for implementation in laboratory and manufacturing operations
• Prepare buffers and reagents, as well as support operation and maintenance of laboratory equipment, including HPLCs, purification columns, spectrometers, and centrifuges
• Support CMC review and verification of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.), with interactions with global Heath Authorities for inspections
• Work with other team members and on cross-functional technical teams

Education & Experience

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related industry experience in biologics downstream manufacturing, biochemistry, chemistry, or manufacturing technology: B.Sc/B.Eng with 3-5 years, M.Sc./M.Eng degree with 0-2 years industry experience
• General scientific knowledge and laboratory skills.  Knowledge in ADC chemistry, conjugation chemistry, reaction processes and downstream purification (chromatography, dead-end and depth filtration, centrifugation, tangential flow ultrafiltration/diafiltration) is preferred
• Demonstrated hands-on experience in the generation of antibody drug conjugates is preferred
• Experience working with Contract Development Manufacturing Organizations (CDMOs) is preferred
• Experience with experimental statistical design and data analysis is preferred
• Experience in problem solving and ability to apply risk-based critical thinking in a technical environment is desired
• Technical communication skills in written and verbal presentation format are essential
• Ability to complete assignments in a timely and compliant manner within given timelines

Work Environment

This role is a combination of laboratory and office-based work.  This position is a team-based position that may require work on evenings, weekends and holidays.

Physical Demands

• Laboratory-based position which requires appropriate levels of personal protective equipment (PPE). This role may require contact with biohazardous materials such as highly potent compounds, payload-linkers, and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on step stools, and reaching may be required. This role may also require unassisted lifting (not to exceed 50 lbs).  Repetitive use of arms/hands/wrists and grasping may also be required
• The position is based indoors and the individual will primarily be working with others, but also independently and alone at times in the laboratory
• The office-based work will require sitting
• The position is a team and project-based position that will require occasional shift work, weekends, evenings, and holidays
• Dynamic, fast-paced, interactive, and entrepreneurial environment 

Travel

This position requires up to 10% of domestic and/or international travel.