Melissa Spencer

Melissa Spencer Email and Phone Number

Senior Manager Development Product QA @ Astellas Pharma
Toronto, ON, CA
Melissa Spencer's Location
Toronto, Ontario, Canada, Canada
Melissa Spencer's Contact Details

Melissa Spencer work email

Melissa Spencer personal email

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About Melissa Spencer

Dynamic leader with extensive knowledge across diverse industries and geographical locales, in both clinical and commercial drug manufacturing. Proactive planner with the ability to deliver high-quality, regulatory-compliant projects on time, leveraging effective organizational and team leadership skills. Known for effective communication and collaboration with internal and external teams. Demonstrated ability to work in fast-paced, time-sensitive environments while maintaining a positive attitude and approach.

Melissa Spencer's Current Company Details
Astellas Pharma

Astellas Pharma

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Senior Manager Development Product QA
Toronto, ON, CA
Melissa Spencer Work Experience Details
  • Astellas Pharma
    Senior Manager Development Product Qa
    Astellas Pharma
    Toronto, On, Ca
  • Nono Inc
    Associate Director, Manufacturing
    Nono Inc Jan 2023 - Present
    Toronto, Ontario, Canada
  • Nono Inc
    Senior Project Lead, Cmc
    Nono Inc Mar 2020 - Feb 2023
    Toronto, Ontario, Canada
  • Transition Therapeutics Inc (A Subsidary Of Opko Health, Inc)
    Director, Cmc
    Transition Therapeutics Inc (A Subsidary Of Opko Health, Inc) Apr 2017 - Mar 2020
    Toronto, On Canada
    Met clinical demands by maintaining project timelines for good manufacturing practices (GMP) drug substance / drug product manufacturing in support of multiple programs in various phases of development.• Successfully navigated multiple products through non-clinical and clinical development phases to commercial viability, with examples including: -> Turn-around of non-commercially viable product by collaborating with third-party lab to develop stable liquid formulation, targeted at diabetes patients, currently in large clinical Phase 2 study, on track for commercialization. -> Overseeing various small molecule products (solid oral dose) through clinical development. -> Working with large pharma partners and contract manufacturing organizations (CMO) through development from active pharmaceutical ingredient (API) in capsule to commercial tablet forms.• Conducted leadership role in major global project to select new drug substance manufacturing site by visiting sites, performing due diligence audits, and working with legal and finance to set up contracts.• Facilitated achievement of overall corporate goals through close work with Clinical, Regulatory Affairs, Legal, and Finance departments to support regulatory submissions and project planning / realization.• Increased productivity and profitability by working directly with senior management on high-level planning of manufacturing activities, contractor selection, and project implementation.• Optimized use of available resources by overseeing operational activities of multiple international vendors including CMOs, CROs (contract researchers), laboratories, and other external partners.
  • Transition Therapeutics, Inc.
    Senior Manager, Pharmaceutical Development & Manufacturing
    Transition Therapeutics, Inc. Feb 2013 - Apr 2017
    Toronto, On
  • Transition Therapeutics Inc
    Quality Assurance Manager
    Transition Therapeutics Inc Apr 2007 - Feb 2013
    Toronto, On
  • Quality & Compliance Services Inc. / Qcr Services Inc.
    Consultant
    Quality & Compliance Services Inc. / Qcr Services Inc. 2001 - 2007
    Mississauga

Melissa Spencer Skills

Research And Development Communication Pharmaceutical Industry Project Management Strategic Planning Validation Biotechnology Fda Quality Assurance Contract And Agreement Negotiation Written Communication Oral Communication Manufacturing Quality Information Gathering And Compilation Stakeholder And Partner Liaison Creative Thinking Problem Solving Creative Problem Solving Gmp Clinical Development Management Pharmaceutics Standard Operating Procedure Product Development Clinical Trials Regulatory Affairs Biotechnology Industry

Melissa Spencer Education Details

Frequently Asked Questions about Melissa Spencer

What company does Melissa Spencer work for?

Melissa Spencer works for Astellas Pharma

What is Melissa Spencer's role at the current company?

Melissa Spencer's current role is Senior Manager Development Product QA.

What is Melissa Spencer's email address?

Melissa Spencer's email address is ms****@****ics.com

What schools did Melissa Spencer attend?

Melissa Spencer attended Queen's University.

What skills is Melissa Spencer known for?

Melissa Spencer has skills like Research And Development, Communication, Pharmaceutical Industry, Project Management, Strategic Planning, Validation, Biotechnology, Fda, Quality Assurance, Contract And Agreement Negotiation, Written Communication, Oral Communication.

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