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CMC Consultant with experience working in large and medium pharma in UK and USA. Successful NDA filings for NCEs and 505(b)(2)s. Success working at the IP/Formulation interface to maximize asset value. Experience managing changes in site, team size, and scope over a 30+ year career.
Harm Reduction Therapeutics
View- Website:
- harmreductiontherapeutics.org
- Employees:
- 5
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Head Of Pharmaceutical DevelopmentHarm Reduction Therapeutics Oct 2018 - PresentLead technical development activities for a virtual non-profit. Leading CMC development, preparing regulatory documentation and performing clinical supply activities at contractors. -
Pharma Cmc ConsultantMannion Consulting Llc Jul 2018 - PresentGreater Philadelphia AreaSuccessful CMC leader with close to 30 years experience managing groups in medium and large pharma organizations. Involved in filing over 10 NDAs and the technical development of several products with over $1Billion in peak sales including NCEs and 505(b)(2). Can assist with high level development strategy, detailed technical development activities or anything in between.Experience of growing teams, consolidating teams, moving teams and repositioning teams in addition to transitioning facilities to GMP. Been part of diligence teams that acquired great products and many that didn't. Led facilities audited by FDA and DEAExpert in the development of abuse deterrent dosage forms.Inventor on challenged patents with courtroom and deposition experience.If you have specific projects, or want to discuss ways to add value to your assets please contact me and we'll schedule a complimentary introductory discussion.
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Executive Director, Pharmaceutical And Analytical DevelopmentPurdue Pharma Oct 2011 - Jun 2018New JerseyLead the group responsible for developing three of the first four opioid products with NDA approvals which include abuse-deterrent labeling.Several patent applications and issued technology patents including 19 issued US patents on abuse deterrent technologies.Multiple depositions related to IP challenges, including several as company expert.Trial prep and testimony2x Chair of AAPS Process Development Focus GroupFormer member of the AAPS Member Groups Coordination CommitteeBD Diligence evaluations and integrationsDeveloped NCEs through all stages in both big and medium pharma environments - including several blockbuster products while at Novartis.Managed the relocation of a formulation development group through a severe downsizing with minimal impact on project timelines. -
Senior Director, PharmaceuticsPurdue Pharma Jan 2001 - Oct 2011 -
Senior ScientistNovartis 1995 - 2001Horsham Uk; East Hanover, Nj.Worked on several successful NDA filings - including Diovan and Starlix which were approved while at Novartis.Other novel products such as Gylenia were approved after 2001. -
ScientistAmerican Cyanamid 1990 - 1995
Richard Mannion Skills
Richard Mannion Education Details
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Pharmaceutical Sciences -
Pharmacy
Frequently Asked Questions about Richard Mannion
What company does Richard Mannion work for?
Richard Mannion works for Harm Reduction Therapeutics
What is Richard Mannion's role at the current company?
Richard Mannion's current role is Pharma CMC Consultant.
What is Richard Mannion's email address?
Richard Mannion's email address is ri****@****rma.com
What is Richard Mannion's direct phone number?
Richard Mannion's direct phone number is +160940*****
What schools did Richard Mannion attend?
Richard Mannion attended University Of Nottingham, University Of Nottingham.
What skills is Richard Mannion known for?
Richard Mannion has skills like Analytical Chemistry, Drug Development, Clinical Development, Biotechnology, Clinical Trials, Computer System Validation, Cro.
Who are Richard Mannion's colleagues?
Richard Mannion's colleagues are George Quesnelle.
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1nch.org
3 +184787XXXXX
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1centurylink.net
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Richard T. Mannion
Redmond, Wa3mannion.co.uk, microsoft.com, microsoft.com1 +120674XXXXX
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