Zhi Li

Zhi Li Email and Phone Number

Director, CMC Lead @ Oruka Therapeutics
Waltham, MA, US
Zhi Li's Location
Ayer, Massachusetts, United States, United States
Zhi Li's Contact Details

Zhi Li work email

Zhi Li personal email

About Zhi Li

• Leading process development and commercial manufacturing support for monoclonal antibodies and fusion proteins. • Areas of expertise include: protein chromatography and filtration, large-scale manufacturing process, process development, and regulatory support. • A strong leader who enjoys collaborating and treats co-workers with respect. • Passionate in delivering life-transforming medicines to patients.

Zhi Li's Current Company Details
Oruka Therapeutics

Oruka Therapeutics

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Director, CMC Lead
Waltham, MA, US
Website:
orukatx.com
Employees:
55
Zhi Li Work Experience Details
  • Oruka Therapeutics
    Director, Cmc Lead
    Oruka Therapeutics
    Waltham, Ma, Us
  • Bristol Myers Squibb
    Associate Director
    Bristol Myers Squibb Nov 2022 - Present
    Lawrence Township, Nj, Us
    • Currently leading a group of 10+ Scientists. Passionate about team members’ development. Established a good reputation as people manager. Leading a Leadership Development Program for the Global MST organization. • Lead my team and cross-functional CMC teams in key activities for commercial lifecycle management, including process characterization, process validation (PPQ), regulatory filing (IND & BLA), and clinical/commercial manufacturing. • Support internal and external manufacturing sites for several commercial and clinical biologics in stainless steel and single-use facilities. • Provide regulatory support (filing, onsite audit, agency queries) for multiple assets (1-2 filings per year). Achieved multi-market approval for several new or next-generation programs. • Lead strategy alignment discussions on process control, validation, and filing with key stakeholders in Development, Manufacturing, Quality, and Regulatory. • Lead innovative research to drive process improvement. Lead method development and implementation readiness for multiple PAT technologies. Filed a patent.• Led process characterization and validation for two accelerated programs: a mAb combo program and an ADC program. • Supported new Cell Therapy Facility (2022): Technology transfer, comparability evaluation, and PPQ of two programs; Troubleshooting for an automated media prep system. • Passionate about digital tools for project and resource management. Coded an Excel-based resource management dashboard for the global MST organization.
  • Bristol Myers Squibb
    Scientific Associate Director
    Bristol Myers Squibb Jul 2022 - Nov 2022
    Lawrence Township, Nj, Us
    6 direct reports
  • Bristol Myers Squibb
    Senior Principal Scientist
    Bristol Myers Squibb Nov 2021 - Jul 2022
    Lawrence Township, Nj, Us
    5 direct reports
  • Bristol Myers Squibb
    Senior Manager
    Bristol Myers Squibb Jun 2020 - Nov 2021
    Lawrence Township, Nj, Us
    4 direct reports
  • Abbvie
    Senior Scientist Ii, Process Sciences - Purification
    Abbvie Nov 2018 - Jun 2020
    North Chicago, Illinois, Us
    • Developed downstream process for 2 biologics and authored IND submissions.• Led tech transfer and manufacturing support for Phase I supply campaign in single-use GMP suite. • Performed troubleshooting and process optimization studies during clinical manufacturing. • Provided CMO service: Managed development and manufacturing of 2 external molecules for clients. • Worked with a CMO: Managed 1 molecule produced at external manufacturer. • Coached 1 full-time direct report.
  • Bristol-Myers Squibb
    Scientist, Manufacturing Sciences & Technology - Downstream
    Bristol-Myers Squibb Mar 2015 - Nov 2018
    Lawrence Township, Nj, Us
    • Led process characterization and improvement studies for late-stage and commercial processes. • Performed viral clearance studies to evaluate impact of process interruption in nanofiltration. • Qualified a new membrane material and optimized process parameters for a UF/DF process. • Provided on-floor support and performed lab troubleshooting studies during PPQ. Authored PPQ reports and supported regulatory filing. • Led deviation investigations for commercial manufacturing. Example: Discovered a systemic risk in analytical reference material qualification procedure and drove the corrective/preventive actions across the network. • 2 years of people management experience: 2 contractors, 2 co-ops, and 1 intern. • Department Safety Lead: Promoted safety culture and led safety-improving activities. • Site Lead of Pan Asian Network: Led career development and cultural celebration events. Grew membership from 9 to 90 employees.
  • Cornell University
    Postdoctoral Associate, Chemistry & Chemical Biology
    Cornell University Jan 2013 - Mar 2015
    Ithaca, Ny, Us
    Principal Investigator: Professor Hening Lin. • Studied mammalian deacetylases as potential anti-tumor targets and microbial metal reductase as bioremediation agents (3 publications).• Routinely conducted protein purification from mammalian and bacterial cells. • Characterized proteins using IEF, Western Blot, HPLC (RP, SEC, IEX), LC/MS, and spectrophotometry. • Completed a 6-month leadership training and received a Postdoc Leadership Certificate.• Taught in a graduate-level course “Principles of Chemical Biology” as an invited speaker.

Zhi Li Education Details

  • University Of Illinois Urbana-Champaign
    University Of Illinois Urbana-Champaign
    Biochemistry
  • Tsinghua University
    Tsinghua University
    Biological Sciences

Frequently Asked Questions about Zhi Li

What company does Zhi Li work for?

Zhi Li works for Oruka Therapeutics

What is Zhi Li's role at the current company?

Zhi Li's current role is Director, CMC Lead.

What is Zhi Li's email address?

Zhi Li's email address is li****@****ail.com

What is Zhi Li's direct phone number?

Zhi Li's direct phone number is +121762*****

What schools did Zhi Li attend?

Zhi Li attended University Of Illinois Urbana-Champaign, Tsinghua University.

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