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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 primary role of the Associate Scientist, Upstream Process Development is to execute laboratory experiments in the development, optimization, characterization, and scale-up of biologics upstream cell culture processes from laboratory to manufacturing scale using knowledge of cell culture, cell banking, medium preparation, bioreactor production, and primary recovery. The role is a combination of laboratory- and office-based work. This role will execute and document laboratory studies in laboratory notebooks. Additionally, this role will support documentation review, protocols, technical reports, change controls, and CMC regulatory submissions under supervision. The Associate Scientist is expected to follow detailed GLP/GMP procedures and safety requirements. This role will work in a team environment and will interact with other functional departments. Additionally, this position is a team-based position that may require work on evenings, weekends, and holidays

Duties & Responsibilities

+ Leverage an understanding of the drug substance upstream cell culture process to support execution and data analysis of scale-down/scale-up studies for media development and optimization, upstream process development, process characterization, and process validation

+ Support development of the upstream inoculum expansion and cell culture process control strategy through identification of critical process parameters and process attributes

+ Support process technical transfers from laboratory-scale or pilot-scale to manufacturing-scale

+ Support process optimization, process robustness initiatives, process troubleshooting, process yield improvements, and process-related investigations at manufacturing-scale through conducting scale-down studies

+ Document execution and results of experimental plans in laboratory notebooks, perform data verification, and author and review SOPs and upstream cell culture 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

+ Support CMC review and verification of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.), with interactions with global Health Authorities for inspections

+ Cell culture expansion and handling utilizing sterile technique in plates, T-flasks, and shaker flasks

+ Support routine operation, cleaning, and maintenance of laboratory equipment, including small-scale and pilot-scale bioreactors, autoclaves, centrifuges, scales, and balances

+ Preparation of media, buffers, and reagents

+ Analyze samples on HPLCs and other analytical instrumentation such as metabolite and cell viability analyzers, and Raman spectroscopy

+ 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 Upstream manufacturing or manufacturing technology:

+ B.Sc/B.Eng with 3-5 years or M.Sc./M.Eng degree with 0-2 years

Knowledge, Skills, Abilities

+ General scientific knowledge and laboratory skills. Knowledge in Upstream mammalian cell culture and bioreactors is preferred

+ Experience with experimental statistical design and data analysis is preferred

+ Experience in problem solving ability 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

Physical Demands

+ 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 office-based work will require sitting.

Work Environment

+ Laboratory-based position which requires appropriate levels of personal protective equipment (PPE). This role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled.

+ 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 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

Up to 10% domestic and/or international travel

Target Bonus

8%

Work Location

East Syracuse, NY

New York Pay Range

$60,000 — $88,000 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!