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Sam Corveleyn

Senior Lead CMC, Drug Development

Head of Drug Product Development CMC, Senior Director at Galapagos

Gent Area, Belgium

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Sam Corveleyn's Email Addresses & Phone Numbers

Sam Corveleyn's Work Experience

Galapagos

Senior Lead CMC, Drug Development

September 2015 to Present

Intrexon Corporation

Director CMC & QP (Intrexon ActoBiotics Division)

March 2015 to August 2015

Belgium

ActoGeniX N.V.

Director CMC; Qualified Person

March 2010 to February 2015

Gent Area, Belgium

Sam Corveleyn's Education

European Compliance Academy

Certified Quality Assurance manager – Pharmaceutical production

2008 to 2009

Mercuri Urval

People management & leadership courses

2006 to 2007

Dynargie

People management & Personalized Leadership

2003 to 2004

Sam Corveleyn's Professional Skills Radar Chart

Based on our findings, Sam Corveleyn is ...

Indulgent
Confident
Talkative

What's on Sam Corveleyn's mind?

Based on our findings, Sam Corveleyn is ...

50% Left Brained
50% Right Brained

Sam Corveleyn's Estimated Salary Range

About Sam Corveleyn's Current Company

Galapagos

Manage CMC process and formulation development, outsourced (non)-GMP manufacturing, clinical packaging of IMPs to support clinical drug development.

Frequently Asked Questions about Sam Corveleyn

What company does Sam Corveleyn work for?

Sam Corveleyn works for Galapagos


What is Sam Corveleyn's role at Galapagos?

Sam Corveleyn is Senior Lead CMC, Drug Development


What is Sam Corveleyn's personal email address?

Sam Corveleyn's personal email address is sa****[email protected]


What is Sam Corveleyn's business email address?

Sam Corveleyn's business email address is s****[email protected]


What is Sam Corveleyn's Phone Number?

Sam Corveleyn's phone (**) *** *** 181


What industry does Sam Corveleyn work in?

Sam Corveleyn works in the Biotechnology industry.


Who are Sam Corveleyn's colleagues?

Sam Corveleyn's colleagues are Wilco Snel, Bart Filius, Luc Rompaey, Pille Harrison, Quoc NGO, and Nicolas Houvenaghel


About Sam Corveleyn

📖 Summary

20 years of experience in the biopharmaceutical industry, holding a PhD in Pharmaceutical Technology from the University of Ghent (Belgium) and EU Qualified Person CMC expert with experience in (bio)pharmaceutical process and formulation development, GMP manufacturing runs, clinical packaging and supply and QP release of IMP.Senior Lead CMC, Drug Development @ Manage CMC process and formulation development, outsourced (non)-GMP manufacturing, clinical packaging of IMPs to support clinical drug development. From September 2015 to Present (3 months) Director CMC & QP (Intrexon ActoBiotics Division) @ Managing all CMC-aspects of ActoBiotics Biological Product development, responsible for all process and formulation development activities; outsourced manufacturing and QC/QA activities to support supply of ActoBiotics across different applications (health; food; environment etc ....). From March 2015 to August 2015 (6 months) BelgiumDirector CMC; Qualified Person @ - Responsible for making an active contribution, at a strategic level and in the day-to-day management of process and formulation development and outsourced manufacturing activities, to support supply of biological drug candidates in early and late stage clinical trials. - Coordinate and manage all formulation and process development, upscaling, cGMP production and clinical packaging and supply activities with external CMO partners. - Managing the CMC-aspect of product development (eg. Tox, cGMP-material, QC and stability studies, clinical labeling and packaging, clinical supply) and coordinating successful implementation and follow-up. - Act as Qualified Person on behalf of the Company in the release and certification of Drug Products for use in Clinical Trials. - Quality and Compliance throughout all CMC operations, responsible for QMS and SMF.  - Act as technical expert on all CMC-aspects of biological Drug Development: playing a cross-departmental advisory and consultancy role, also in support of Business Development.  - Responsible for CMO screening/selection and CMO contract negotiations.  - Writing and reviewing the Quality sections of all regulatory dossiers for FDA and EMA (Scientific Advise packages, IND, IMPD). From March 2010 to February 2015 (5 years) Gent Area, BelgiumManager CMC Regulatory Affairs, Qualified Person @ Coordinate and manage process development, cGMP production, clinical packaging and IMP supply activities with external CMO partners: solve problems in collaborative teams, build consensus, implement solutions and act as the key CMC-contact for the third party contractors. Act as Qualified Person on behalf of the Company in the release and certification of IMPs for use in Clinical Trials. Guarantee appropriate Quality and Compliance throughout all external CMC collaborations: review and approval of QA-agreements and responsible for external and internal cGMP Auditing. From July 2007 to February 2010 (2 years 8 months) Gent Area, BelgiumManager Product Development @ Pharmaceutical and analytical development Analytical validation Pilot batch production and process development Stability studies Team leader (9 direct reports) From 2002 to 2007 (5 years) Brussels Area, BelgiumProduct Development Supervisor @ Pharmaceutical Development Analytical Development and validation Stability studies From 1998 to 2002 (4 years) Brussels Area, BelgiumResearcher, PhD student @ Ph.D. Thesis : "Evaluation of maltodextrins as excipiënts in the formulation of freeze-dried pharmaceutical dosage forms". From 1993 to 1998 (5 years) Gent Area, BelgiumPharmacist @ Pharmacist in a Pharmacy in Belgium From July 1993 to August 1993 (2 months) Bruges Area, BelgiumCertified Quality Assurance manager – Pharmaceutical production @ European Compliance Academy From 2008 to 2009 People management & leadership courses @ Mercuri Urval From 2006 to 2007 People management & Personalized Leadership @ Dynargie From 2003 to 2004 PhD, Pharmaceuticals @ Ghent University From 1989 to 1998 Science @ Koninklijk Atheneum Oostende From 1985 to 1996 Conservatorium Oostende From 1982 to 1995 Sam Corveleyn is skilled in: GMP, Drug Development, Biopharmaceuticals, Pharmaceutical Industry, CMC, Formulation, Regulatory Affairs, GLP, Formulation Development, Pharmaceuticals, eCTD, Quality Assurance, Stability studies, IND, CMC Regulatory Affairs


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In a nutshell

Sam Corveleyn's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

2 year(s), 9 month(s)

Sam Corveleyn's Willingness to Change Jobs

Unlikely

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