LOTTE BIOLOGICS located in East Syracuse, NY is seeking Scientist, Materials Science to join our team who entered the biologics Contract Development Manufacturing Organization (CDMO) business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, on January 1, 2023! 

The Scientist, Materials Science within Manufacturing Sciences and Technology (MSAT) is responsible for leading MSAT material science and readiness activities for technical transfer, process development, process validation, and GMP manufacturing. The candidate will be the subject matter expert for 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. The Scientist will work in collaboration with process development and MSAT, site operations, supply chain, procurement, QC/QA, and customers to design, evaluate, and validate these materials. Additionally, the Scientist will drive SUT and RM process standardization, strategy sourcing, and control strategy in collaboration with cross-functional teams using in-depth knowledge of industry best practices and regulatory guidelines. The Scientist will also be accountable for material readiness activities, including but not limited to, review and/or authorship of material and consumable-related risk assessments, material suitability assessments, material shelf program, material storage conditions, material particle profile, elemental impurity assessments, review supplier change notifications for impact, and review new/modified consumables design drawings. The Scientist will also lead and author study protocols and final reports for extractables and leachables, and container closure assessments to support the product lifecycle.

• In depth understanding of materials used in biopharmaceutical processes, including but not limited to cell culture media, chemicals, resins, filters, excipients, consumables, and single-use systems
• Serve as a subject matter expert for direct materials, including raw materials, excipients, consumables, and single-use technologies, used in biologics development and MSAT laboratories, as well as in biomanufacturing
• Lead the Assessment of new materials, and implement best practices in SUT and RM across multiple programs, including a phase-appropriate program and control strategy based on scientific and risk principles
• Provides technical expertise, leadership, and authorship for: manufacturing investigations, material implementations, material change controls, SUT component design reviews for SUT, alternate material qualifications, technical transfers, technical reports, white papers, and technical material risk assessments
• Develop Standard Operating Procedures (SOPs) and guidance documents to assess new materials (SUT and RM) in collaboration with Manufacturing, Process Development, MSAT, Manufacturing, Supply Chain, Procurement, and Quality Compliance and Quality Assurance teams to ensure a systematic process for material onboarding, new/alternate material selection, material characterization, as well as address material improvements and alternate sourcing opportunities
• Support identification and control of critical material attributes related to process performance
• Lead extractable and leachable risk assessment and studies
• Provide technical expertise in container closure integrity test (CCIT) and CCIT technology for drug substance and drug product
• Knowledge of common material analytical tools, and demonstrated experimental skills for laboratory work, may be required
• 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
• Interact directly with Health Authority inspections and with customer audits
• Design, author, and review required Material Sections of regulatory filings and support the review of the CMC documentation and Health Authority requests
• Support GMP deviation/investigation and change controls as a material science expert
• Strong verbal and written communication skills, as well as excellent interpersonal skills with the ability to work seamlessly in a multifunctional team environment

Education/Experience:

• Degree in Material Science Engineering, Bioengineering, Organic chemistry, Polymer Science, Biochemical, Chemistry, or equivalent experience working in Manufacturing/Contract Manufacturing: Minimum of a B.Sc/B.Eng with 6+ years, M.Sc/M.Eng degree with 4+ years, or Ph.D. degree with 0-2 years experience
• Minimum of 2+ years prior experience in single-use technologies, filters, chromatography resins, excipients, and primary packaging and/or secondary packaging, including prior experience working on consumable and single-use assessments
• Strong knowledge of chemical raw material standards (USP, compendia, BPOG, etc.) and strong knowledge in extractable and leachable, container closure integrity testing, and raw material risk assessments
• Strong understanding of polymers and chemicals, as well as their function in bioprocesses and impact on cells
• Experience with cGMP regulations, regulatory requirements, and CMC authoring for biologics processes are preferred
• Demonstrated problem-solving ability and strong collaboration and team-building, communication, and organizational skills required
• Experience working with and managing third-party contractors and vendors
• Experience owning, managing, and executing records using a quality management system is preferred

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.
• 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

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.