Stephen Macmichael

Stephen Macmichael Email and Phone Number

Document Control Coordinator - Quality Assurance @ Tavanta Therapeutics
Philadelphia, PA, US
Stephen Macmichael's Location
Philadelphia, Pennsylvania, United States, United States
About Stephen Macmichael

Chemical Engineer with seven years of experience in pharmaceuticals, biologics, and cell and gene therapies. Significant experience in document management and data review of quality and analytical-related data, including physical and digital databases for patient files, training records, and clinical manufacturing. Strong expertise with computer skills and analytical problem-solving skills.

Stephen Macmichael's Current Company Details
Tavanta Therapeutics

Tavanta Therapeutics

View
Document Control Coordinator - Quality Assurance
Philadelphia, PA, US
Website:
tavanta.com
Employees:
8
Stephen Macmichael Work Experience Details
  • Tavanta Therapeutics
    Tavanta Therapeutics
    Philadelphia, Pa, Us
  • Tavanta Therapeutics
    Quality Assurance Associate
    Tavanta Therapeutics Aug 2023 - Present
    Supported TAVT-119, an amlodipine besylate gel in development for pain associated with anal fissure, and TAVT-45, a novel oral suspension of abiraterone acetate.- Oversaw the Quality Assurance documentation management systems of SOLABS and Microsoft Office for the entire company- Reviewed protocols, analytical methods, and specification documents used in making drug products in Phase 2/3- Outlined and wrote standard operating procedures with relevant department heads to ensure proper training for on and off-site personnel
  • Celularity Inc.
    Document Control Coordinator
    Celularity Inc. Dec 2021 - Mar 2023
    Florham Park, Nj, Us
    Supported CYNK-101 and CYNK-001 for treating solid tumors, and Biovance and Interfyl for biomaterial wound healing.- Managed physical and digital databases for patient files, training records, and clinical processing runs- Became very experienced with document control systems Veeva and SharePoint, including producing training reports, updating and maintaining SOPs, and documenting various Quality Events- Helped pioneer document tracking system Palantir within the company, including maintaining proper records of files that were on and off site, ensuring the exchange of records between departments was adequately tracked, and producing metrics for monthly reports- Created strong rapport with other departments to ensure their requests were met, including setting up filing systems, providing training forms and reports, and updating their curricula to reflect provided training matrices
  • Eagle Pharmaceuticals, Inc.
    Analytical Development Scientist
    Eagle Pharmaceuticals, Inc. May 2019 - Feb 2020
    Us
    Supported Eagle’s line of products including Bendeka for lymphocyte leuchemia, Ryanodex for malignant hyperthermia, Pemfexy for small cell lung cancer, and Fulvestrant for treating breast cancer.- Designed and implemented a data warehouse for Eagle's new drug development diluent program- Utilized the company SharePoint sites to organize and identify data from multiple laboratories so that employees can evaluate real time data- Create and implement a shared sample tracking program for all outsourced analytical testing across al current projects- Generated purchase orders and designed a semi-automated spreadsheet for cataloging previous and current purchases within the department- Prepared Gantt charts and swim lane flowcharts for visualizing and maintaining the Analytical department's projects and goals- Supported the Analytical department in ad hoc assignments and projects
  • Eagle Pharmaceuticals, Inc.
    Quality Assurance Intern
    Eagle Pharmaceuticals, Inc. May 2018 - Aug 2018
    Us
    - Participated in validation of the electronic documentation system by executing test scripts and reporting results- Updated Quality Assurance forms to work electronically by making them digitally fillable- Created product complaint and change control reports in their Quality Management system software (i.e. SOLABs)- Participated in laboratory tours of Eagle partners to familiarize with standard industry practices and better understand the role of the supplier / vendor relationship at Eagle
  • Eagle Pharmaceuticals, Inc.
    Quality Assurance Intern
    Eagle Pharmaceuticals, Inc. May 2017 - Aug 2017
    Us
    - Created automated reports for product quality complaints, change controls, and training for Quality Assurance within their electronic document management system- Filed and organize manufacturing batch records and other Quality Assurance related documents, and- Trained on cGMP practices, FDA CFRs, and internal Eagle policies and procedures

Stephen Macmichael Education Details

  • Villanova University
    Villanova University
    Chemical Engineering

Frequently Asked Questions about Stephen Macmichael

What company does Stephen Macmichael work for?

Stephen Macmichael works for Tavanta Therapeutics

What is Stephen Macmichael's role at the current company?

Stephen Macmichael's current role is Document Control Coordinator - Quality Assurance.

What schools did Stephen Macmichael attend?

Stephen Macmichael attended Villanova University.

Who are Stephen Macmichael's colleagues?

Stephen Macmichael's colleagues are Enikő Bákány, Balázs Kárpáti, Zsolt Ötvös, Andreas Maetzel, Bence Szilágyi.

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