P R O F I L E

E X P E R I E N C E

H E A D Q U A L I T Y C O N T R O LLEGACY PHARMACEUTICALS SWITZERLAND GMBH | MAR 2013 - CURRENT

• Official duties acc. to EU-GMP as ‘Leiter Qualitätskontrolle’.• Reorganisation of QC to team leader structure.• Introduction of current GMP standards in QC.• Driving an Operational Excellence initiative throughout QC.• Implementation of 5S as common work practise.• Substitution of old databases/work procedures/DMS.• Implementation of new Quality Systems (paper based or electronic).• Leading a long term project team (new API manufacturing route).• Auditing function: Internal/external audits as lead auditor (dept./suppliers),

representative in case of audits/inspections by customers/authorities• Direct contact of world-wide authority requests.• Experienced in chemical API/biologics/finished products/steriles.• Responsible for equipment acquisition and qualification status.

H E A D O F M E T H O D VA L I D AT I O N Q ADOTTIKON EXCLUSIVE SYNTHESIS AG | JAN 2011 - FEB 2013

• Coordination and accomplishment of analytical method validation projects (cGMP).

• Transfers of methods into routine use for regular production.• Customer support and project management of various projects (up to

CHF5M).• Expertise on stability studies (ICH).• Various autonomous projects with major pharmaceutical players.• Replacement of LIMS and time recording system in various functions.

H E A D O F R & D C H R O M AT O G R A P H I C C O L U M N SMETROHM AG | FEB 2006 - FEB 2008

• Development of stationary phases for IC including market release.• Development of auxiliary equipment for LC.• Implementation of new division into Metrohm AG.• Management of development projects.• Upscaling of newly introduced production processes (ISO 9001).• Contact for world-wide key account manager.• Single point of contact for projects run at universities/research centers.

T E A M L E A D E R VA L I D AT I O N & S TA B I L I T Y S T U D I E S Q CDOTTIKON EXCLUSIVE SYNTHESIS AG | MAR 2008 - DEC 2010

• Coordination and accomplishment of stability studies (ICH).• Supervision of analytical method validation activities (cGMP).• Troubleshooting support for production campaigns.• Customer service for all technical questions.• Implementation of new department.

E X P E R T I S E

Compl iance GMP

Leadership

Project Management

CMO (API/FP)

D R . M I C H A E L T H E I S

H e a d Q u a l i t y C o n t r o l

C O N TA C T

A: Stirnrütistrasse 56, 6048 Horw (LU), Switzerland

E: huskyte@mac.com P: +41 79 171 8275

As chemist phd Michael Theis brings a strong chemical background along as well as an

extraordinary intention in leadership, change management and creative ways of solving challenging situations within a regulated

environment. He does have the ambition to keep a superior overview of complex

procedures and is capable of keeping focus in challenging situations.

P R O F I L E

D E TA I L S

Born 4th April 1977 (Wiesbaden)Married, one son

E D U C AT I O N

R E S E A R C H A S S O C I AT E / P H D T H E S I SPHILIPS-UNIVERSITÄT MARBURG | NOV 2003 - DEC 2005

• Department: Analytical Chemistry, Prof. Dr. A. Seubert.• ‘New stationary phases for ion chromatography’.• Grade: With honour.

S T U D I E SPHILIPS-UNIVERSITÄT MARBURG/GOETHE-UNIVERSITÄT FRANKFURT | 1997 - 2002

• Study course: Chemistry.

R E F E R E N C E S

DR. NIKOLAS EPPGroup Manager Post Marketing Clinical Science, Geistlich Pharma AGE: tbdP: tbd

ROBERTO CURSERIQuality Management, Schott AGE: tbdP: tbd

DR. PETER ZIMMERMANNHead of Improve Plant Laboratories, DSME: tbdP: tbd

DR. SANDRA VAN DER KRUIJSSatoris Stedim BiotechE: tbdP: tbd

R E S E A R C H F E L L O W S H I PHONEYWELL SEELZE AG | NOV 2001 - OCT 2003

• Section: Fine chemicals.• Development, transfer and validation of analytical methods.• Highly pure optical substances in direct competition to Merck.• Scope: Market lead as lithographic supplier.

D I P L O M A T H E S I SPHILIPS-UNIVERSITÄT MARBURG | JUL 2002 - OCT 2002

• Department: Analytical Chemistry, Prof. Dr. A. Seubert.• ‘Synthesis and investigation of latex particles for the use as stationary

phases for ion chromatographie’.• Grade: With honour.

T R A I N I N G S• Executive Leadership Program (SGMI, 2015)• Die Rolle der Fachtechnisch Verantwortlichen Person, Concept Heidelberg,

2014• GMP-/FDA-Compliance in der Qualitätskontrolle, Concept Heidelberg, 2013• Transfer of analytical methods, Concept Heidelberg, 2012• Validation of analytical methods, Concept Heidelberg, 2011• MS Excel, internal audit training, Quality management systems, cGMP, DES

2008 - 2011• Business administration, VHS Marburg, 2003 - 2004• Quality assurance, Universität Marburg, 2004 - 2005• Training course Cambridge certificate, St. Gallen, 2007 - 2008• …

D R . M I C H A E L T H E I S

H e a d Q u a l i t y C o n t r o l

C O N TA C T

A: Stirnrütistrasse 56, 6048 Horw (LU), Switzerland

E: huskyte@mac.com P: +41 79 171 8275

CHRISTIAN ARNOLDQuality Manager, Synergy Health PLCE: tbdP: tbd

A P P E N D I X

Certificates:• Interim report Legacy 2014• Reference letter Dottikon 2013• Interim report Dottikon 2011• Reference letter Metrohm 2008• Executive Leadership Program,

SGMI• phd thesis certificate• Chemistry studies certificates• Certificates Concept Heidelberg• Program certificate Concept

Heidelberg