Scientist, Downstream Process Development at LOTTE BIOLOGICS

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 a Scientist, Downstream Process Development (Manufacturing Sciences & Technology) to design and execute laboratory experiments in the development, optimization, characterization, and scale-up of biologics downstream purification processes to support process lifecycle activities with a focus on early process development through TOX/FIH. The Downstream Scientist will also support process validation and commercialization for various downstream processes. The Downstream Scientist will use drug substance knowledge, risk management strategies, and design of experiments to determine downstream critical quality attributes, process attributes, process parameters, as well as process-specific materials and consumables which can influence product quality. The role is a combination of laboratory- and office-based work. The Downstream Scientist 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 and will be a subject matter expert working in a team environment and interacting with other functional departments. Additionally, this position is a team-based position that may require work on evenings, weekends, and holidays.

Remote Position

Min Compensation

Max Compensation

Bonus

Qualifications

Education/Experience:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related industry experience in biologics downstream manufacturing or manufacturing technology: B.Sc/B.Eng with 5-7 years, M.Sc./M.Eng degree with 2-4 years, or Ph.D degree with 0-2 years of relevant industry experience
• Demonstrated scientific knowledge and laboratory skills in downstream purification (chromatography, dead-end and depth filtration, centrifugation, tangential flow ultrafiltration/diafiltration, viral inactivation and viral filtration) is preferred
• Experience with experimental statistical design and data analysis is desired
• Experience with CMC document preparation, as well as interactions with global Health Authorities is desired
• Demonstrated problem solving ability and ability to apply risk-based critical thinking in a technical environment is desired
• Effective technical communication skills in written and verbal presentation format are essential
• Demonstrated ability to complete assignments in a timely and compliant manner, with minimal supervision

Specific Knowledge, Skills, Abilities, Etc.:

• Leverage drug substance downstream purification process knowledge to design, execute, and analyze scale-down chromatography and filtration laboratory studies for process development, process characterization, and process validation
• Collaborate with cross-functional teams and provide process technical support
• Support risk assessments and Quality by Design (QbD) approaches to establish design space and study designs to execute laboratory experiments for development of scalable downstream purification processes across the process lifecycle
• Communicate project strategy, milestones, and conclusions to stakeholders
• Execute experimental designs and statistical analysis of results to develop conclusions and make recommendations for development of the downstream purification process control strategy
• Support process technical transfers from laboratory-scale or pilot-scale to manufacturing-scale, as well as process troubleshooting across different process scales through the effective design of scale-down studies and the evaluation of data across scales
• Document execution and results of experimental plans in laboratory notebooks, perform data verification, and author and review 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
• Lead continuous process improvements and advance technology for implementation in laboratory and manufacturing operations
• Demonstrate familiarity with preparation of buffers and reagents, operation and maintenance of laboratory equipment, including HPLCs, purification columns, spectrometers, and centrifuges
• Interact with global Health Authorities for site inspections and CMC review and authoring of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.) and inquiry responses
• Ability to prioritize, independently manage and complete deliverables within given timelines
• Train, mentor, and coach team members

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 live cell cultures 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

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.