LOTTE BIOLOGICS located in East Syracuse, NY is seeking Sr Quality Specialist 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!

This position is responsible for the approval of investigations related to the Quality Control laboratory, Environmental Monitoring excursions, quality system/compliance deviations, and the biologics manufacturing process. The position reviews and approves MBRs, SOPs, laboratory documentation, and ensures the quality of manufactured products adhere to the highest standards of GMP compliance.

• Drives performance within the quality operations team and ensures key quality metrics are met.
• Provides support to functional areas in the identification, reporting and resolution of deviations or non-conformances.
• Demonstrates independent decision making and leadership.
• Supports investigation and CAPA teams across all functional areas on site. Leads teams and drives improvement where CAPA resolution is required.
• Responsible for authorship and revision of quality related procedures.
• Responsible for quality assurance review and/or approval of site SOPs, MBRs, Templates, etc.
• Provides quality leadership on project and/or risk assessment teams.
• Ensures all quality review and support activities adhere to the highest standards of GMP, EHS and regulatory compliance.
• Works independently with minimal guidance; uses knowledge and expertise to develop other team members.
• Implements and oversees continuous improvement projects within Quality Operations and support areas.
• Coordinates and leads meetings/discussions related to quality events with SME’s and site leadership.
• Supports the site by participating in internal/external inspections and audits.

• Knowledge of biologics manufacturing is preferred.
• Demonstrated knowledge of US and EU cGMP regulations and guidance.
• Experience with cGMP documentation review is required.
• Experience with Regulatory agencies and inspections is preferred.
• Experience with Human Error investigations and Root Cause Analysis tools is highly preferred.
• Individual must be able to communicate clearly and succinctly, both verbally and in writing.

Education/Experience/ Licenses/Certifications:

• Knowledge of science generally attained through studies resulting in a B.S. degree in Chemistry, Biology, Engineering, or related discipline, or its equivalent is required.
• Four years of related experience in the pharmaceutical or biologics industry is required.

Physical Demands:

• Primarily an office based position requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists, and reaching.

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.