Associate Director, Analytical Sciences & Technology at LOTTE Biologics

Job Locations US-NY-East Syracuse
ID
2023-3084
Category
Other
Position Type
Regular Full-Time

Overview

Lotte Biologics Company Logo

 

LOTTE BIOLOGICS located in East Syracuse, NY is seeking an Associate Director, Analytical Sciences & Technology 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!

Responsibilities

The Associate Director, Analytical Science and Technology is responsible for leading a team of analytical scientists to provide lifecycle management of analytical testing methods. The candidate will be responsible for executing the overall scientific, technical, and operational efforts across the method lifecycle. The candidate will oversee activities including, but not limited to, method development, method transfer, phase appropriate method qualification/validation, non-GMP testing, non-GMP stability, reference standard qualification, and comparability for biologics and other modalities to support clinical and/or commercial GMP manufacturing. The candidate will also provide expertise and guidance to support laboratory investigations and troubleshooting for QC and operational issues, as applicable.

 

This is a leadership position responsible for the strategic planning and growth of the Analytical Development and Lifecycle functions. The role will also be responsible for leading a team of subject matter experts to execute the overall scientific, technical, and operational efforts. The candidate will communicate and execute the analytical strategy, with routine interaction with clients, and will also deliver analytical methods needed to meet project milestones and new product introductions while maintaining associated regulatory and ICH requirements. The candidate will also lead cross-functional efforts to develop analytical CMC strategies, while providing tactical direction for the development and execution of the analytical project plan. The candidate will work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects.

 

  • Demonstrated ability to lead and develop people.
  • Strong written, verbal, presentation, and interpersonal communication skills.
  • Ability to analyze complex analytical problems, develop strategic initiatives, execute technical programs, articulate and clearly communicate scientific objectives and project results, and make recommendations to executive management and clients.
  • Experience developing bridging studies between new and existing methods, method comparability studies, and product comparability studies required to support CMC changes.
  • Experience leading analytical method change controls within a Quality Management System and ensuring all required test data and reports are available to support and justify the change(s).
    • Experience authoring and coordinating test methods to ensure timely transfer of test methods with and to Quality Control laboratories.
    • Experience defining analytical control strategy, owning and coordinating the specifications development process, preparing the specification package documents, and driving the process for internal and regulatory approval of the specifications.
  • Demonstrated experience and understanding of the regulatory and ICH requirements in CMC development activities including authoring and reviews of method validation documentation and CMC analytical sections of regulatory submissions which includes registrational critical quality attributes, comparability studies, reference standard qualification, and overall control strategy for IND/BLA documentation
  • Coordinates laboratory activities and actively participates in regulatory inspections, third-party audits, and customer audits including addressing CMC-related inquiries from regulatory agencies to support commercial marketing applications, inspection preparation and management, and addressing inspectional findings is required.

Remote Position

No

Bonus

18%

Qualifications

  • BS in science with at least 15 years, MS with at least 10 years, or Ph.D. with at least 8 years of related industry experience with strong hands-on experience with biologic/protein analytics
  • Experience in analytical method development, method transfer, and method validation in protein biotherapeutics across a variety of analytical methodology and instrumentation used in the testing and characterization of raw materials, excipients, in-process samples, drug substances, and drug products including HPLC methods and various other analytical techniques (ie. qPCR, ELISA, western blotting, host cell proteins, concentration, host cell proteins, and cell-based assays) is required. Demonstrated history of continuous improvement is desired.
  • Transfer of processes and methods from development to clinical manufacturing to commercialization is necessary.
  • Strong working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is required.
  • Broad knowledge of risk-based Quality Systems components including Quality Risk Management is required.

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.

 

Location:

East Syracuse, NY

Company Website

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.

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