William Wilde, Msem Email and Phone Number
William Wilde, Msem work email
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William Wilde, Msem personal email
Entrepreneurial biopharma professional with over 15 years of continual achievement that includes operations management, new product development, cGMP manufacturing, and NDA responsibilities. I'm currently an Associate Director in the CMC group at Boston Biomedical, an oncology therapeutics developer. I have been fortunate to attain experience in the creation and advancement of a new drug application (NDA). I also work closely with the Clinical Supply and Quality teams in ensuring that all ongoing clinical trials are supplied on time with cGMP quality drug product.Previously, at Repligen Corporation I was responsible for the design and manufacture of custom chromatography devices for multinational biopharma clients. OPUS® was the first ever Repligen-branded bioprocessing device and its success was pivotal in enabling the company to shift its strategic focus to the bioprocessing segment of the life sciences industry. During my 5+ years there I also made significant contributions to the quality management systems, commercial operations, supply chain logistics, and integration of newly acquired businesses. In 2015 I earned an MS in Engineering Management from Tufts University where I was the recipient of the “Distinguished Student” award in recognition of my leadership qualities and academic performance.
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Director, Cmc Project ManagementSumitomo Pharma America, Inc. Jul 2023 - PresentMarlborough, Massachusetts, Us
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Director, Cmc Project ManagementBoston Biomedical, Inc. May 2019 - Present
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Associate Director, CmcBoston Biomedical, Inc. Sep 2016 - May 2019Manages a diverse portfolio of CMC projects including:- Technical contributor and reviewer of CMC sections of New Drug Application (NDA) for a small molecule oncology drug product- Drug product process validation - Coordination of drug product CMOs to ensure that multiple clinical trials are adequately suppliedAlso contributes strategic program management in technical transfers and scale-up, demand-supply analysis, as well as general budget tracking/forecasting.
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Associate Director, Production And DevelopmentRepligen Corporation Mar 2014 - Sep 2015Waltham, Ma, UsOperations leader for the production and development of chromatography and filtration devices for major biopharma clients. I also made impactful contributions to supply chain operations, new acquisition integration, and continual improvement of operations via lean manufacturing methods (e.g. value stream mapping). -
Opus Production And Development ManagerRepligen Corporation Mar 2012 - Mar 2014Waltham, Ma, UsPlayed a foundational role in Repligen's ability to both develop and manufacture bioprocessing devices. This newly established competency supported the firm's decision to shift its strategic focus to the bioprocessing space.Ensured that all products were manufactured in compliance with Repligen's cGMP-driven quality system which included: writing/revising batch records/SOPs, deviation and investigation reports, change controls, and CAPAs.
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Bioprocess EngineerRepligen Corporation Feb 2010 - Mar 2012Waltham, Ma, UsProject management of a new product development effort that included:- Hands on R&D of a new chromatography column platform via experimentation and reporting- Conducted competitive benchmarking, primary and secondary research, IP search, etc. - Created documents required to enable the sale and manufacture of the product line- Identified and qualified appropriate suppliers of standard and custom fabricated components- Identified and coordinated collaboration with a product development consultancy for design support (i.e. mechanical, industrial, and user-focused design)Integrated an acquired chromatography product line into Repligen's ISO 9001 quality system.
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Contractor - Quality SpecialistRepligen Corporation Aug 2009 - Feb 2010Waltham, Ma, UsAudited manufactured lots of recombinant protein for compliance to ISO 9001 quality management system requirements
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Manufacturing AssociateAltus Pharmaceuticals Nov 2006 - Mar 2009Us- Liaison to international CMOs in Japan and Czech Republic- Supported the tech transfer of clinical manufacturing process to commercial CMO site.- Performed batch record review for compliance to cGMP standards- Executed root cause investigations and authored deviation reports as necessary- Partnered with Quality, Process Engineering, and Supply Chain groups to ensure the availability of clinical trial material and process transfer between CMOs -
Senior Manufacturing AssociateRepligen Corporation Oct 2002 - Nov 2006Waltham, Ma, UsKey contributor to a growing manufacturing organization. Obtained foundational experience in recombinant protein manufacturing operations, quality systems, and people/process management.- Prepared and operated chromatography columns (BPG, Chromaflow)- Prep and operation of various filtration unit operations (MF, UF, Depth Filtration)- Wrote/revised SOPs and master batch records for all unit operations
William Wilde, Msem Skills
William Wilde, Msem Education Details
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Tufts UniversityEngineering Management -
Providence CollegeBiology
Frequently Asked Questions about William Wilde, Msem
What company does William Wilde, Msem work for?
William Wilde, Msem works for Sumitomo Pharma America, Inc.
What is William Wilde, Msem's role at the current company?
William Wilde, Msem's current role is Experienced CMC Professional.
What is William Wilde, Msem's email address?
William Wilde, Msem's email address is ww****@****cal.com
What schools did William Wilde, Msem attend?
William Wilde, Msem attended Tufts University, Providence College.
What are some of William Wilde, Msem's interests?
William Wilde, Msem has interest in Independent Travel, Snowboarding, Economics, Music, Behavioral Economics, International Business And Politics.
What skills is William Wilde, Msem known for?
William Wilde, Msem has skills like Protein Purification, Gmp, Biotechnology, Root Cause Analysis, Lifesciences, Chromatography, Product Development, Process Management, Fda, Biopharmaceuticals, Technology Transfer, Life Sciences.
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