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!

To help us meet our mission LOTTE BIOLOGICS is in need of an Associate Scientist, Materials Science within our Manufacturing Sciences and Technology (MSAT) department.  The Associate Scientist is responsible for supporting MSAT material science and readiness activities for technical transfer, process development, process validation, and GMP manufacturing. The Associate Scientist will work in collaboration with process development and MSAT, site operations, supply chain, procurement, QC/QA, and clients to design, evaluate, and validate raw materials (RMs), single-use technologies (SUTs), excipients, and consumables for process development, as well as late-stage and commercial drug substance manufacturing of biopharmaceuticals and antibody drug conjugates (ADCs). Additionally, the Associate Scientist will support SUT and RM process standardization, strategy sourcing, and control strategy in collaboration with cross-functional teams. The Associate Scientist will also be accountable for supporting material (RMs and SUTs) related activities, including but not limited to, review and/or authorship of material risk assessments, change controls, material suitability assessments, material specifications, material shelf-life program, material particle profile, elemental impurity assessments, review supplier change notifications for impact, and review new/modified consumables design drawings.

Education/Experience:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related industry experience in biologics, materials science, manufacturing or manufacturing technology: B.Sc/B.Eng with 3-5 years or M.Sc./M.Eng degree with 0-2 years
• Knowledge of chemical raw material and excipient standards (compendia, ICH, BioPhorum, etc.) is preferred
• Knowledge of single-use technologies, filters, chromatography resins, excipients, and primary packaging and/or secondary packaging and applicable standards (BPSA, BioPhorum, ICH, etc.) is preferred
• Experience with cGMP regulations, regulatory requirements, and CMC authoring for biologics and ADC processes is preferred
• Demonstrated problem-solving ability and strong collaboration and team-building, communication, and organizational skills is required
• Experience working with third-party contractors and vendors
• Experience owning, managing, and executing records using a quality management system is preferred
• Knowledge of common material analytical tools, and demonstrated experimental skills for laboratory work is preferred

Specific Knowledge, Skills, Abilities, Etc.:

• General understanding of materials used in biopharmaceutical processes, including but not limited to cell culture media, chemicals, resins, filters, excipients, consumables, and single-use technologies (SUTs)
• Complete assessments of new and existing materials, and support implementation of best practices and end-to-end lifecycle management
• Author and review material technical assessments, risk assessments, and change controls for new and alternate material implementation and qualifications for SUTs and RMs across multiple programs
• Provide technical expertise and authorship for material gap analysis, SUT component design reviews, as well as material technical transfers, technical reports, and white papers
• Support materials-related cGMP deviations and CAPAs, including determination of product or process impact, root-cause analysis, and corrective action identification
• Establish material specifications through matrix leadership with functional partners
• Support identification and control of critical material attributes related to process performance
• Design, prepare, and review protocols, methods/processes, and experimental plans relevant to material workflows through collaborations with third parties for planning/execution of outsourced studies and/or supervise internal and external customer laboratory studies, as applicable
• Develop Standard Operating Procedures (SOPs) and guidance documents to assess new materials (RM and SUT) in collaboration with Manufacturing, Process Development, MSAT, Manufacturing, Supply Chain, Procurement, Quality Compliance, and Quality Assurance teams
• Strong verbal and written communication skills, as well as excellent interpersonal skills with the ability to work in a multifunctional team environment

Physical Demands:

• Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
• Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment:

• Position is primarily office based, with occasional work in a classified GMP manufacturing environment and/or laboratories.
• Dynamic, fast-paced, interactive, and entrepreneurial environment. 
• Position is a team and project-based position that will require occasional shift work, weekends, and holidays.

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! 

http://www.lottebiologics.com/

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.