Susan Knowles

Susan Knowles Email and Phone Number

Clinical and Commercial Drug Product Manufacturing and Operations Expert @ TScan Therapeutics
Susan Knowles's Location
Wakefield, Massachusetts, United States, United States
Susan Knowles's Contact Details
About Susan Knowles

Innovative problem solver and skilled communicator focused on effective relationship management with 20 years of clinical and commercial manufacturing and operations experience. Developed manufacturing process ranging from startup through commercial approval. Experience in establishing and tech transfer of clinical and commercial manufacturing processes. A diverse background working within both a small and large pharmaceutical companies as manufacturing SME and business operations manager. Experience in managing and leading multi-disciplinary development, clinical and commercial teams, with a focus on process and productivity improvements.

Susan Knowles's Current Company Details
TScan Therapeutics

Tscan Therapeutics

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Clinical and Commercial Drug Product Manufacturing and Operations Expert
Susan Knowles Work Experience Details
  • Tscan Therapeutics
    Sr Director Program Leadership And Cmc Operations
    Tscan Therapeutics Jan 2024 - Present
    Waltham, Massachusetts, Us
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  • Tscan Therapeutics
    Director, Cmc Operations
    Tscan Therapeutics May 2022 - Present
    Waltham, Massachusetts, Us
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  • Kiniksa Pharmaceuticals
    Director, Commercial Product & External Manufacturing
    Kiniksa Pharmaceuticals Aug 2021 - Jan 2022
    Lexington, Massachusetts, Us
    Responsible for manufacturing oversite of commercial products.
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  • Sarepta Therapeutics
    Associate Director Drug Product Manufacturing
    Sarepta Therapeutics Jul 2019 - Aug 2021
    Cambridge, Ma, Us
    Responsible for managing a group of Drug Product technical experts in support of third party manufacturers for both existing commercial products and the technology transfer of new products.Led validation of late stage product for commercial launch.
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  • Alnylam Pharmaceuticals
    Sr Manager, Cmo Management
    Alnylam Pharmaceuticals 2017 - Jul 2019
    Cambridge, Massachusetts, Us
    External manufacturing operations lead responsible for contract manufacturing partnerships to deliver supply commitments on time and on budget for starting materials, Drug Substance and Drug Product.Led internal and external teams ensuring the successful manufacturing of GMP batches.
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  • Ovascience
    Sr. Technical Project Manager
    Ovascience Aug 2015 - Apr 2017
    Provide technical support for third party manufacturers. Focusing on the technology transfer of drug substance, drug product and custom media, to new manufacturing sites. Responsibilities include developing and managing detailed project plans, charters, budgets, and schedules for multiple, high visibility projects. Lead ongoing internal and external project meetings, delivering a monthly milestone/dashboard report to ensure on time execution of tasks and visibility of project status.
  • Shire Hgt
    Sr Process Engineer
    Shire Hgt Jun 2011 - Aug 2015
    Led multiple cross functional teams responsible for outsourced manufacturing projects at various phases of development to support the technical transfer of the processes for clinical and commercial manufacturing of drug products; including liquid and lyophilized products.
  • Cubist Pharmaceuticals
    Process Engineer
    Cubist Pharmaceuticals May 2007 - Jun 2011
    Lexington, Ma, Us
    Responsible for the design and execution of experiments in support of commercial manufacturing processes, including but not limited to, chromatography, filtration, lyophilization, and spray drying.Managed the formulation development, scale up, and characterization for a new spray dried drug product from laboratory scale to commercial scale.
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  • Wyeth Biotech
    Process Engineer
    Wyeth Biotech 2000 - 2007
    New York, New York, Us
    Assist in the development of final drug product formulations for liquid and lyophilized products.Perform scale up work on lyophilization cycles from development to commercial scale.
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Susan Knowles Skills

Gmp Biotechnology Technology Transfer Biopharmaceuticals Validation Fda Change Control Life Sciences Capa Sop 21 Cfr Part 11

Susan Knowles Education Details

  • Post University
    Post University
    Project Management
  • University Of Massachusetts Lowell
    University Of Massachusetts Lowell
    Chemical Engineering
  • University Of Massachusetts Lowell
    University Of Massachusetts Lowell
    Chemical Engineering

Frequently Asked Questions about Susan Knowles

What company does Susan Knowles work for?

Susan Knowles works for Tscan Therapeutics

What is Susan Knowles's role at the current company?

Susan Knowles's current role is Clinical and Commercial Drug Product Manufacturing and Operations Expert.

What is Susan Knowles's email address?

Susan Knowles's email address is ks****@****ksa.com

What is Susan Knowles's direct phone number?

Susan Knowles's direct phone number is +185862*****

What schools did Susan Knowles attend?

Susan Knowles attended Post University, University Of Massachusetts Lowell, University Of Massachusetts Lowell.

What skills is Susan Knowles known for?

Susan Knowles has skills like Gmp, Biotechnology, Technology Transfer, Biopharmaceuticals, Validation, Fda, Change Control, Life Sciences, Capa, Sop, 21 Cfr Part 11.

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