My working experience

06/2021 - today

Chapter Lead, (Head) IPC & Synthesis Labs

Basel DS Manufacturing @ F. Hoffmann-La Roche AG 

• Lead and develop the IPC&Synthesis Chapter (approximately 25 direct reports) and drive the strategic development of the chapter (staff, equipment, lab space, processes).

• Ensuring analytical and synthetical services to support the value streams (production of small molecules, large molecules (stainless steel and single use) and antibody-drug conjugates) in Basel DS to ensure market production as well as tech transfers / launches

• Direct the chapter to ensure that testing is compliant with the regulations and cGMP requirements.

• Overall coordination of projects and MAR activities in the laboratories and resource allocation within the chapter according to site priorities and goals.

• Maintaining the safety standard in close colaboration with SHE and PSU Departement

• Create an environment with strong team spirit, timely and effective communication, sense of urgency, and high motivation to achieve operational objectives 

08/2019 - 05/2021

Head of DSP Operations

Biologics DS Manufacturing @ F. Hoffmann-La Roche AG

• Lead and develop the MAB95 Downstream Operations teams (approximately 50 employees, two hirarchy levels)

• Ensure required staff training regarding cGMP, procedures, automation, and equipment

• Ensure products are manufactured on time and to high quality according to regulatory requirements and internal Roche standards. Coordination of all production activities and batch record reviews

• Coordinate the processing of discrepancies, CAPAs, Changes, risk assessments as well as implementation of sustainable measures

• As a member of the production leadership team, ensure and promote collaboration between operations as well as with the entire organization

• Create an environment with strong team spirit, timely and effective communication, sense of urgency, and high motivation to achieve operational objectives

• Represent downstream operations during government inspections and represent the entire Manufacturing organization on local and global task forces or project teams  

01/2018 - 07/2019

Head of QC Direct Material Testing

Biologics DS Manufacturing @ F. Hoffmann-La Roche AG

• Leading and developing direct reports (7 direct reports)

• Responsible for sampling and analysis of direct materials in a cGMP compliant manner

• Management of specifications and methods for physical and chemical testing

• Implement of strategic goals and objectives within group

• Working in global network teams

• Representation of the division in internal and external audits

• Reorganised own organisation into SM to save resources 

09/2013 - 12/2019

Team leader QC raw materials

Biologics DS Manufacturing @ F. Hoffmann-La Roche AG

• Leading and developing direct reports (3 direct reports)

• Responsible for testing of direct materials in a cGMP compliant manner

• Management of specifications and methods for physical and chemical testing

• Representation of the division in internal and external audits

• Responsible for implementation of QC testing for new Materials within the TT framework 

06/2012 - 08/2013

Deputy Lab Head

Small Molecules DS Manufacturing @ F. Hoffmann-La Roche AG

• Review and Approval of test results

• Planning and scheduling of testing activities

• Production support (Trouble shooting)

• Handling of lab discrepancies

• Deputy laboratory head in his absence 

06/2006 - 05/2012

Laboratory Technician

Small Molecules DS Manufacturing @ F. Hoffmann-La Roche AG

• Lab testing of IPC samples in different labs

• Techniques: HPLC, GC(HS), (KF-)Titrations, ORD, turbidity, density determination, pH, wet chemistry

• Maintenance of equipment (requalification)

• responsible for an apprentice 

08/2005 - 05/2006

Laboratory Technician

Small Molecules DP IMP @ F. Hoffmann-La Roche AG

• Lab testing of DP Development samples

• GMP und non-GMP testing of HPLC, HPLC-MS

• Dissolution testing