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 a Cryogenics/Cold Chain Scientist responsible for developing and implementing strategies for freezing, thawing, storage, and shipping processes for both biologics drug substance, as well as other modalities including antibody drug conjugates (ADCs). This role will define the process control strategy for cryogenics manufacturing and establish the technical strategy for drug substance cryogenics and cold-chain processes. This role is a combination of laboratory- and office-based worand will execute laboratory studies and author documentation, including protocols, technical reports, change controls, and CMC regulatory submissions. This role is expected to follow detailed GLP/GMP procedures and safety requirements. This role will be a subject matter expert working in a team environment and will interact with other functional departments. Additionally, this role is a team-based position that may require work on evenings, weekends, and holidays.

Remote Position

No

Min Compensation

USD $76,000.00/Yr.

Max Compensation

USD $113,000.00/Yr.

Bonus

10%

Qualifications

Education/Experience:

Degree in Biochemical/Chemical Engineering, Pharmaceutical Sciences, or equivalent area of related industry experience in biologics and/or ADC manufacturing: B.Sc/B.Eng with 5-7 years, M.Sc./M.Eng degree with 2-4 years, or Ph.D degree with 1-2 years of relevant industry experience. Masters or PhD is preferred, but not required.
Demonstrated expertise in heat transfer fundamentals is required.
Knowledge of shipping qualification, transportation and packaging design desired.
Knowledge of protein dynamics, formulation, and stability, particularly the effects of freezing and thawing on protein stability is desired.
Knowledge of common protein analytical tools and demonstrated experimental skills for laboratory work is required.
Strong verbal and written communications skills desired. Proficient in writing formal reports, articles for publication and technical presentation
Interpersonal skills with the ability to work in cross-functional teams
Demonstrated proficiency at experimental and troubleshooting aptitude
Experience with cGMP regulations, regulatory requirements, and CMC authoring for biologics processes is desired

Specific Knowledge, Skills, Abilities, Etc.:

Serves as a subject matter expert for cryogenics and transportation processes of commercial and late-stage biologics drug substance across contract storage/manufacturing sites, with clients, and with Drug Product (DP) sites.
Recommend and execute strategies for cryogenics and cold chain processes to support technology transfers between DS and DP sites, ensuring seamless integration and collaboration across sites and with/for clients
Provides technical support for product manufacture, validation, and technology transfer of cryogenics and transportation processes.
Plan and execute multiple projects and strategic initiatives to support the development and implementation of new cryogenics, cold chain, and shipping processes and technologies
Designs, prepares and reviews protocols, methods/processes, experimental and/or authoring plans and/or templates relevant to cryogenics and transportation workflows. Authors relevant risk assessments, change controls, and technical reports.
Direct the cryogenics characterization laboratory activities and define the strategy for managing and harmonizing the qualification of DS shipping lanes and primary containers
Collaborates with third parties for planning/execution of outsourced shipping studies
Interact with global Health Authorities during site inspections and contribute to submissions, regulatory responses, and briefing documents
Serve as the subject matter expert for technical investigations, change controls, impact assessments, and continuous improvement pertaining to DS cold chain, cryogenics, and transportation-related processes.
Develop and implement cutting-edge technologies for freezing, thawing, and shipping biologics and ADCs
Collaborate with Supply Chain, Regulatory, Quality, Process Development, Engineering, and Operations with clients and across sites
Designs, prepares and reviews required CMC documentation as appropriate.
Identifies, executes and leads process/system improvement projects

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 cell vials and drug substance. Low temperatures may also be encountered from dry ice, cold temperatures, and cryogenics. 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

http://www.lottebiologics.com/

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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