Scientist Upstream Process Development at LOTTE Biologics Job at MACNY's Job Board
Overview:
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
We deliver therapies that make a Healthier World
Responsibilities:
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:
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 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 new
Scientist for Uptream Process Development to execute laboratory experiments in the development, optimization, characterization, and scale-up of biologics upstream cell culture and primary recovery processes to support process lifecycle activities, with a focus on early process development through TOX/FIH. In this critical role you will;
- lead process validation and commercialization for various upstream processes
- use strong drug substance knowledge to design experiments that determine critical quality and process attributes, process parameters, and consumables that impact quality
- while working in the lab and the office, drive experiment execution, data analysis, process recommendations, and author documentation, including protocols, technical reports, change controls, and CMC regulatory submissions
- be a subject matter expert for upstream cell culture processes including bioreactor scale-down model development and media optimization
- follow detailed GLP/GMP procedures and safety requirements
It’s important to know that you will be working in a team environment that may require being on site evenings, weekends, and holidays.
Remote Position: false Qualifications:
To be successful in this role the Scientist for Upstream Process Development must have the demonstrated knowledge, skills, and abilities in the following;
- Leverage understanding of the drug substance upstream cell culture process to design, execute, and analyze scale-down cell culture studies in shake flask, cell bag bioreactor, seed and production bioreactor, and primary recovery laboratory studies for process development, process characterization, and process validation
- Support risk assessments using Quality by Design (QbD) to establish design space and study designs to execute laboratory experiments for development of scalable upstream cell culture processes across the process lifecycle
- Support upstream 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
- Demonstrate familiarity with preparation of media, cell expansion in plates, T-flasks, shaker flasks, and lab- and pilot-scale bioreactors, as well as operation and maintenance of laboratory equipment including autoclaves, centrifuges, HPLCs, balances, metabolite and cell viability analyzers
- Minimal education and experience should be a B.Sc/B.Eng with 5 years in the field, or Sc./M.Eng degree with 2 years, or a Ph.D degree with some relevant upstream cell culture industry experience
- Demonstrated scientific knowledge and laboratory skills in upstream cell culture including mammalian cell culture, bioreactors, and primary recovery and experience with experimental statistical design and data analysis
- Experience with process engineering scale-up strategies including kLA, P/V, optimization of operating parameters (pH, temperature, media composition, oxygen concentration, gas flowrates, etc.) is desired
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!
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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