Associate Scientist, Antibody Drug Conjugate (ADC) & Purification Development at LOTTE BIOLOGICS

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Job description

Overview:

We are LOTTE BIOLOGICS! 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.

We deliver therapies that make a Healthier World!

Responsibilities:
To help us meet our mission LOTTE BIOLOGICS is in need of an Associate Scientist, Antibody Drug Conjugate (ADC) & Purification Development within our Manufacturing Sciences & Technology (MSAT) organization. The primary role of the ADC Associate Scientist 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. 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.

Remote Position:
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Min Compensation :
USD $60,000.00/Yr.

Max Compensation :
USD $88,000.00/Yr.

Bonus:
8%

Qualifications:
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

Specific Knowledge, Skills, Abilities, Etc.:

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

Physical Demands/Work Environment:

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.

Work Location:

East Syracuse, NY

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!

Company Website:

Company Profile:
LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb's Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry. With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30+ global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

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