Hong Lin

Hong Lin Email and Phone Number

Manager @ Astellas Pharma
Kenmore, WA, US
Hong Lin's Location
Kenmore, Washington, United States, United States
Hong Lin's Contact Details
About Hong Lin

Analytical Scientist with more than 10 years working experience in the pharmaceutical lab Skills. Specialized in method development and validation to support the different stages of the drug product development from the preliminary exploration to the commercialization, and developing innovation solutions to challenges in product design, process optimization, troubleshooting and scale up. Train peers and juniors, and grow the analytical team to support the internal and external teams.Also skilled at overseeing and managing CROs and CDMOs, and developing innovation solutions to challenges of product design, process optimization, and scale up. Experienced in laboratory research and development activities including assay development, filtration and characterization, HPLC/UPLC, LC-MS, GC, UV/VIS spectroscopy, PSD, DSC, XRPD, dissolution, NGI, ACI, and related techniques. Lead analysis of various R&D and GMP stability studies. Drafted protocols, report, and technical memos. Played a QA role to support the Quality team by generating the specifications, reviewing the batch records, stability report, CAPA, deviations and related tasks. An SME to provide the scientific insight for the cross-functional team to rive the programs.

Hong Lin's Current Company Details
Astellas Pharma

Astellas Pharma

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Manager
Kenmore, WA, US
Hong Lin Work Experience Details
  • Astellas Pharma
    Manager
    Astellas Pharma
    Kenmore, Wa, Us
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  • Astellas Pharma
    Manager
    Astellas Pharma May 2023 - Present
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  • Impel Neuropharma
    Senior Scientist, Analytical Lead
    Impel Neuropharma Feb 2022 - Mar 2023
    Seattle, Washington, Us
    Oversee analytical method development, transfer and validation, operations and stability studies for clinical and commercial stage critical raw materials, drug substance, drug product, and finished products.Oversee analytical method development, transfer, validation, and operations, including release and stability studies for: critical raw materials, drug substance, drug product, and finished products.Provide oversight for contract analytical services and the transfer of analytical methods to CRO and CMO partners.Review and approval of relevant analytical documents including raw data, method validation protocols/ reports, specifications, and stability reports.Provide guidance to team on various technical issues.Escalate significant analytical issues to management and project teams in a timely manner, drive mitigation or problem-solving activities.Provide technical support for regulatory filings, health authority questions, change control and quality impact assessments.Build collaborative relationships with key internal team members, stakeholders, and external customers.
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  • Impel Neuropharma
    Scientist, Analytical Method Development Lead
    Impel Neuropharma Jan 2020 - Feb 2022
    Seattle, Washington, Us
    Analytical methods for various internal and external projects (new and commercialized) products in support of process analytical technologies (PAT) for commercial manufacturing processes or early phase of new drug productIndependent development and validation of analytical test methods for APIs, excipients, and drug products using industry standard methodologiesEnsure complaint principles for analytical methods by following US FDA, USP, ICH guidelines.Evaluate/study/qualify new vendors for suitability based on stability studiesConduct characterization studies and analysis of material in the laboratory.Lead analysis of samples for various R&D and GMP stability studies.Draft protocols, reports, technical memosOversee and manage CROs/CDMOs)Train peers and junior staff members on new techniques.
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  • Impel Neuropharma
    Research Associate Iii
    Impel Neuropharma Mar 2018 - Jan 2020
    Seattle, Washington, Us
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  • Impel Neuropharma
    Research Associate Ii
    Impel Neuropharma Feb 2017 - Mar 2018
    Seattle, Washington, Us
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  • Pace Analytical
    Analyst Ii
    Pace Analytical Jun 2015 - Oct 2016
    Minneapolis, Mn, Us
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  • Perrigo Company Plc
    Chemist
    Perrigo Company Plc Nov 2014 - May 2015
    Dublin, County Dublin, Ie
    View

Hong Lin Skills

Chemical Engineering Matlab Chemistry Process Optimization Data Analysis R Hplc Statistics Design Of Experiments Science Process Engineering Biomass Spectroscopy Analytical Chemistry Environmental Engineering Renewable Energy Biofuels Laboratory Skills High Performance Liquid Chromatography Scanning Electron Microscopy Laboratory Uv/vis

Hong Lin Education Details

  • University Of Washington
    University Of Washington
    Bioresource Science And Engineering
  • Beijing Forestry University
    Beijing Forestry University
    Paper Science And Engineering

Frequently Asked Questions about Hong Lin

What company does Hong Lin work for?

Hong Lin works for Astellas Pharma

What is Hong Lin's role at the current company?

Hong Lin's current role is Manager.

What is Hong Lin's email address?

Hong Lin's email address is li****@****lnp.com

What schools did Hong Lin attend?

Hong Lin attended University Of Washington, Beijing Forestry University.

What skills is Hong Lin known for?

Hong Lin has skills like Chemical Engineering, Matlab, Chemistry, Process Optimization, Data Analysis, R, Hplc, Statistics, Design Of Experiments, Science, Process Engineering, Biomass.

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