06/2021 - today

Chapter Lead, (Head) IPC & Synthesis Labs

Basel DS Manufacturing @ F. Hoffmann-La Roche AG 

• Spearheaded the strategic in-sourcing of analytical method validation, eliminating reliance on external contractors and achieving six-figure annual cost savings.

• 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

• Successfully led the department through multiple regulatory audits by rigorously ensuring all testing complied with 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 Department

• 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

• Successfully navigated the department through the COVID-19 pandemic, ensuring 100% operational continuity and team safety by implementing dynamic scheduling and strategic team separation protocols

• Directed a cross-functional task force to identify and eradicate a major biofilm contamination, developing and executing mitigation plans that allowed for continued production while resolving the issue

• Led, coached, and developed the Downstream Operations teams (approx. 50 employees across two hierarchical levels), overseeing all technical and cGMP-related training programs

• Directed all production activities to ensure on-time, high-quality manufacturing in full compliance with regulatory requirements, including the management of batch records, discrepancies, and CAPAs.

• Represented the manufacturing organization during government inspections and on local and global project teams.

01/2018 - 07/2019

Head of QC Direct Material Testing

Biologics DS Manufacturing @ F. Hoffmann-La Roche AG

• Initiated and led a strategic reorganization to merge multiple teams with similar functions, a successful consolidation that enhanced synergies and eliminated three positions, including my own

• 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