Stephanie Chen

Stephanie chen

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location of Stephanie ChenRaleigh, North Carolina, United States
Followers of Stephanie Chen311 followers
  • Timeline

  • About me

    Upstream MS&T Engineer II at KBI Biopharma

  • Education

    • North carolina state university

      2017 - 2021
      Bachelor's degree chemical engineering, minor in biomanufacturing sciences
  • Experience

    • North carolina state university- college of veterinary medicine

      Aug 2019 - Dec 2019
      Undegraduate research assistant

      • Autoclaved equipment and media used within the laboratory (biohazardous waste) to ensure sterile operations• Prepared cell cultures, and T-streaked onto petri dishes to track bacterial pathogens, E.coli and Salmonella, for the prevention of infectious diseases

    • Gsk

      Jun 2020 - Aug 2020
      Engineering intern

      • Created a spare parts list for a 50L/200L single-use bioreactor to obtain quotes from vendors • Optimized the efficiency of freezer units on site by identifying freezer failures and contacting vendors for quotes on new cooldown chambers• Helped determine ways to decrease site’s utilities’ costs and environmental impact• Conducted engineering risk assessments on HPLC machines, plate readers, and gas chromatography machines to ensure safety compliance• Familiarized myself with SOP and GMP documentation Show less

    • Kbi biopharma

      Aug 2021 - now

      • Client Education & Engagement: Educated 10+ clients on outsourced test methods, enhancing client understanding, product safety, and regulatory compliance. Created Purchase Orders (PO) for outsourced tests. • Cross-functional collaboration: Scheduled and led Joint Project Team meetings, facilitating seamless communication between clients, Manufacturing, Supply Chain, Quality Assurance, and Process Development, ensuring the timely execution of deliverables. • Compliance and Process Validation: Authored and tracked regulatory documentation, including process performance qualification protocols, deviation impact assessments, quality risk management (FMEA), and campaign summary reports. • Information Management: Maintained Upstream SharePoint folders for clients technology transfer documentation. Utilized Smartsheets to track and assign deliverables for clients. Show less • Project Management: Led technology transfer of 11, clinical and PPQ, cGMP manufacturing processes for 7 different clients, ranging from early-stage biopharma companies to large pharma organizations, focusing on scale-up and resulting in a 100% client renewal rate. • Operations Management: Provided on-call support to make forward processing decisions, troubleshoot, and deliver data-driven insight for process improvement initiatives. Created and presented Manufacturing training slides for unique process operations.• Community Relationships: Managed client and vendor visits, safeguarding propriety information, representing the company’s brand with integrity. Show less

      • Upstream MS&T Engineer II

        Sept 2023 - now
      • Upstream MS&T Engineer I

        Aug 2021 - Sept 2023
  • Licenses & Certifications