Dan Pearce Email and Phone Number
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- Responsible for manufacturing, supply chain, warehousing, engineering and MS&T for cell and gene therapy across 3 facilities in the UK- Strong operational and quality leadership, influencing and collaboration skills with strategic decision making and organizational awareness- Led the establishment of a clinical GMP quality system, product life cycle, tech transfer and qualification requirements for manufacture of lentiviral vector in a new facility- Responsible for the design and establishment of manufacturing, supply chain and technical requirements for a $20m new cell and gene therapy facility in the UK for a novel iPSC-derived allogeneic Tcell Drug Product- Successful application for new MIA(IMP) for site of QP importation certification of cell and gene therapy products- 20 years experience manufacturing licensed parenteral, biologics, ophthalmics pharmaceutical and cell & gene therapy within Quality Assurance and Operational roles- Acted as site representative for medical device accreditation to ISO 13485- An experienced supplier auditor in finished product, API and excipient manufacture (including Indian & Chinese locations), together with distribution/storage sites and contract laboratories with accreditation as IRCA-certified Lead Auditor- Process improvement proficiency as a qualified Lean 6-sigma Greenbelt.
Autolus Therapeutics
View- Website:
- autolus.com
- Employees:
- 736
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Vice President Of Supply Chain, Engineering, Qualification And TrainingAutolus TherapeuticsOxford, Gb
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Vice President, European Manufacturing & Technical OperationsAdaptimmune Feb 2021 - PresentAbingdon, Oxfordshire, Gb -
Senior Quality Director - Uk/EuAdaptimmune Jul 2019 - Feb 2021Abingdon, Oxfordshire, Gb
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Uk Quality DirectorAdaptimmune Oct 2017 - Jul 2019Abingdon, Oxfordshire, Gb
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Global Director, Supplier Quality AssuranceCatalent Pharma Solutions Nov 2014 - Oct 2017Somerset, Nj, UsTeam: Globally 5 direct reports in China, US, France. Indirect responsibility for supplier qualification activities and personnel at each of Catalent's manufacturing, testing and distribution sitesRole Remit:- Responsible for risk based supplier quality and audit processes within Catalent applying strategic direction to globalising the function while ensuring existing and new GMP requirements are incorporated into the program.- Perform rigorous audits of Catalent supplier facilities providing specific areas of improvement and provide guidance to site supplier quality personnel on compliance requirements in the form of defined policies and standards. - Driving consistent supplier quality at all Catalent sites by enhancing and monitoring the supplier management program requirements. - Responsible for measuring and analysing supplier quality data across Catalent and identifying, targeting and driving specific areas of improvement- Responsible for reporting audit data and other metrics that demonstrate Catalent compliance to senior management at suitable frequencies. - Provide advice and guidance to Catalent sites on responses to supplier audit findings and ensure that citations are thoroughly addressed and communicated across all Catalent sites where appropriate. -
Global Compliance AuditorCatalent Pharma Solutions Feb 2014 - Nov 2014Somerset, Nj, UsThe Catalent Compliance function is responsible for conducting internal manufacturing compliance assessments worldwide to assure that practices, policies, procedures, and standards are appropriately implemented to meet Corporate requirements and all applicable regulations and guidance. Proactive sharing of audit themes, regulatory changes and best practice ensures a low risk rating for inspection readiness.The role is exposed to the entire breadth of products, functions, services and solutions offered by Catalent.
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Quality Assurance ManagerGenus Pharmaceuticals Apr 2011 - Jan 2014Newbury, Berkshire, GbTeam: 2 direct reports, 2 in-direct contract QPsResponsible for the oversight and management of the GMDP Quality SystemRole remit:- Ensure that medicinal products supplied to the company from 40+ CMOs and 40+ API suppliers are manufactured and distributed in compliance with the law and the respective Marketing Authorisations. - Ensure implementation of GMDP audit program; PQR/stability commitments; control outsourcing contracts; timely batch release; complaint response, deviation management etc.- Act as host and direct contact position with the MHRA inspectorate- Progress the pharmaceutical development and commercial scale manufacturing process validation for all existing products and future line extensions. Provide technical and quality support for existing commercial products with third-party suppliers. -
Quality Assurance ManagerPatheon Mar 2008 - Apr 2011Waltham, Massachusetts, UsTeam: 7 direct reports, wider responsibility for 30Responsible for the Quality Assurance of manufactured product from 7 aseptic filling and 6 non-sterile production lines Role remit:- Incoming & finished product testing, sterilisation & facility re-qualification, sterility assurance compliance and batch review & release- Provided a client interface for numerous top 10 pharma companies with a portfolio of 9 commercial clients- Host audits from regulatory bodies including FDA, MHRA and clients - QA lead for new facility and equipment qualification (e.g. new aseptic cleanroom build, filling machines, 2D printers etc.) -
Qa Section HeadPatheon Jul 2007 - Mar 2008Waltham, Massachusetts, UsTeam: 4 direct reports Accountable for documentation review, identification & risk assessment of quality issues within Production.Role remit:- Deviation assessment, change control approval- Host/support client & regulatory audits- Client feedback and liaison on specific issues- Approving multiple validation documentation types - Support the external supplier audit programme
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Process Development Scientist - Sterile CtmPatheon Jun 2006 - Jul 2007Waltham, Massachusetts, UsResponsible for the oversight of manufacture and development of processes for aseptic clinical material including filtration validation, compounding activities, equipment qualification utilising disposable filling technologies.
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Quality Assurance ExecutivePatheon Feb 2005 - Jun 2006Waltham, Massachusetts, Us
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Microbiology Scientific OfficerPatheon Aug 2002 - Feb 2005Waltham, Massachusetts, Us
Dan Pearce Skills
Dan Pearce Education Details
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University Of BathBiology -
Aylesbury Grammar School
Frequently Asked Questions about Dan Pearce
What company does Dan Pearce work for?
Dan Pearce works for Autolus Therapeutics
What is Dan Pearce's role at the current company?
Dan Pearce's current role is Vice President of Supply Chain, Engineering, Qualification and Training.
What is Dan Pearce's email address?
Dan Pearce's email address is da****@****ent.com
What schools did Dan Pearce attend?
Dan Pearce attended University Of Bath, Aylesbury Grammar School.
What skills is Dan Pearce known for?
Dan Pearce has skills like Gmp, Quality Assurance, Aseptic Processing, Auditing, Microbiology, Continuous Improvement, Quality Systems, Supplier Auditing.
Who are Dan Pearce's colleagues?
Dan Pearce's colleagues are Ella Bonner, Juliette Dutemple, Sundip Dhillon, Mohamed El-Kholy, Katool Springston, Mike Sonnenberg, Mark Fitzpatrick.
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