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 a Scientist, Investigations & Compliance, Manufacturing Technology to conduct high quality root cause analysis investigation of GMP Quality Events. The level of responsibility and complexity of investigations and additional projects undertaken will typically increase with grade level.

• Conducts and manages resolution of deviations, root cause investigations, impact assessments, and corrective action/preventive actions (CAPAs) as a Quality Event Lead Investigator
  • Liaise with multiple groups and organizations as a Lead Investigator to lead cross-functional investigation teams
  • Conduct assessments of quality events to evaluate potential impact
  • Conduct root cause analysis for quality events with potential impact
  • Identify opportunities for improvement of process performance and/or quality event reduction through CAPA development
  • Proactively manage progression of investigation and CAPA to timely closure
  • Author presentations and documentation summarizing investigational findings
  • Present investigation findings to key stakeholders, including site management, global teams, and clients
• Support projects for productivity, robustness, quality, business process, and safety improvements
• Author and review technical documents including protocols/technical reports, SOPs, and risk assessments
• Support MT initiatives, such as process monitoring, process improvement projects and evaluation to identify process risks, as well as suggest recommendations for process and analytical robustness with remediation

Education/Experience/ Licenses/Certifications:

• Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing:
  • 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
• Knowledge of biologics manufacturing and/or cGMP investigations is strongly preferred
• Prior experience in or knowledge of cell culture, recovery, and/or purification is strongly preferred

Specific Knowledge, Skills, Abilities, etc:

• Experience in problem solving ability and ability to apply risk-based critical thinking in a technical environment
• Technical communication skills in a written and presentation format are required, including ability to present information clearly and concisely
• Interpersonal and collaboration skills to interface with and influence all levels of the organization
• Ability to work with management to appropriately prioritize and complete deliverables within given timelines
• Demonstrated basic project management skills (organization, collaboration, multi-tasking, and communication), attention to detail with high quality output, and ability to lead diverse cross-functional teams of subject matter experts

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
• Position is a team & project-based position that will require occasional shift work, weekends, and holidays

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.