Lead Data Analyst Quality Control at LOTTE Biologics

Overview

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 Lead Data Analyst, Quality Control with bio/pharmaceutical analytical statistical experience  to provide oversite of the method performance monitoring program.  This position will support routine method performance monitoring activities and provide data/statistical analysis of method performance and release data as part of the Syracuse Data Analytics (DA) team. This group partners with biologics Quality Control, Analytical Science & Technology (AST), Manufacturing (MST/MT) and external analytical partners.

• Provide routine monitoring and performance analysis of quality control analytical methods using applicable statistical process and tools.
• Provide statistical guidance to Data Analytics team, inclusive of authoring investigational reports, to support findings in QC analytical data related to release data (OOS) and method performance (OOT) generated within Syracuse QC laboratories.
• Facilitate discussions with QC method subject matter expert (SME) to ensure robust data analysis is completed to support method performance investigations.
• Provide method performance reports, data and/or statistical support to cross-functional teams (Syracuse QC/QA, AST, MST/MT) to drive method performance improvements and/or changes.
• Provide direct support to QC laboratories to drive method performance improvements.
• Provide oversight for QC analytical data request activities including compilation and data verification.
• Provide direct support in the optimization and standardization of analytical method performance data assessments, monitoring and trending capabilities.
• Partner with Digital Plant and Lab System Administrators to build, implement and maintain method performance monitoring applications for all methods performed within the Syracuse Quality Laboratory to ensure method performance monitoring consistency.
• Provide support during PMI/LES application maintenance related activities.

Remote Position

Min Compensation

Max Compensation

Bonus

Qualifications

Education/Experience/ Licenses/Certifications:

• BS degree in Bio/Statistics, biological sciences, or related discipline with relevant experience of minimum of 7 years of bio/pharmaceutical related in relevant fields OR M.S. degree with minimum of 3 years of experience.

Knowledge, Skills, Abilities: 

The ideal candidate should demonstrate the following proficiencies:

• Thorough understanding of cGMP compliance and laboratory documentation concepts (e.g., good documentation practices, SOP's, etc.).
• Broad experience in trending/statistical analysis of biological quality control method data.
• Competent with statistical software applications (i.e. SAS/JMP)
• Working knowledge with data management systems (i.e. LabWare, LIMS, LES)
• Strong oral and written communication skills.
• Strong interpersonal skills: this position requires collaboration with cross-functional teams within BMS network.
• Demonstrates ability to work independently with limited supervision
• Demonstrates organizational, well-developed attention to detail, and time management skills.

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

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.