Interim Head of Production

• Expert in sterile & aseptic manufacturing within pharma and biotech industry

• Experience within the production / manufacturing of vaccines, e.g. due to projects within the last 3 years

• Great personality with strategic mindset who enjoys working hands-on

• Helps people create adaptive, fast-moving organizations that can respond quickly and flexibly to new opportunities and challenges as they arise

• Excellent references from previous projects via K-Recruiting

• Product Types: freeze-dried powders, semi-solid drugs, vaccines

• Manufacturing / Contract Manufacturing of liquid and semi-solid medication

• Immediate Productivity and Efficiency Improvement at Aseptic Production of Parenteral in the Biopharmaceutical Industry

• Commissioning and establishment of trouble-free production for 2 new production lines with a new team, incl. roll-out of Business Excellence Standards

Deliverables:

• Operational Excellence Program deployed

• Continuity of the production process restored

• Liquid team and lines are up and running, with one - after the first campaign - second production line on qualification

• 23% output beyond plan with about half of the staff needed

• increase of production volume by 40 percent

• reduction of the rejects by 3 percent

• Training program enabled

• Product Types: Oncolytic Viruses | Viral Vectors | Vaccines

• GMP Cell Banking | GMP Viral Banking | Technical Transfer | Process & Analytical Development | GMP Manufacture | Fill & Finish | Lot / Batch Release | Stability Studies

• Executive-, operations-, change- and project management related to rapid business growth & internationalization

• Managing the department and ensuring that aseptic, GMP compliant filling processes including visual inspection, labelling and packaging are carried out on time

• Project and process planning and implementation

• Review and release of manufacturing documents

• Review and release of quality-relevant documents such as SOPs, risk analyses and qualification documents

• Processing of Deviation, Change Control and CAPA

• Management and survey of qualification and maintenance of process relevant equipment

• Training of employees

• Participation in customer meetings and audits

Deliverables:

• process development and implementation

• 3 times the production volume implemented with half of the team

• Team Leadership, Training and Education to safeguard

• Product Quality

• Development of operational concepts in terms of avoiding cross contamination, cleaning and training

• Cross-functional work: starting from pharmaceutical quality assurance, over cross-departmental strategic concepts

• Qualification & Validation

• SOP creation

• GAP Analysis: Deviations, CAPAs, Audit Findings

• Audit and inspection readiness

• Conduct Trainings

Deliverables:

• Development of concepts

• Consolidated process management

• Aligned training program & visual management

• Complemented by deployment of global lean six sigma- and agile projects

• Central responsibility for the production

• Reporting to the VP Operations

• Disciplinary and professional leadership of approx. 150 employees, incl. apprentices and temporary worker

• Ensuring high quality production acc. to GMP standards

• Support and supervision of managers and employees in all related topics

• CAPA Management, incl. Change control

• Progression of existing work and personnel processes

• Process improvement and implementation in alignment with FDA/EMEA requirements

• Consolidation after reorganization and restructuring

Deliverables:

• Addition of a new product group (here: Biologics)

• Introduction of a new shift system

• Increase in production volume by 52%

• Reduction of sick days by 35%

• Increase of employee availability by 17%

• Central responsibility for the production (incl. Maintenance)

• Quality Management (GxP) incl. operative support (Deviations / CAPA; OOX; Changes)

• Validation and qualification

• Disciplinary & professional leadership of approx. 120 employees

• Participation in the project team for the development and implementation of a MES software

• Process improvement and implementation in alignment with IFS requirements

• Analysis and improvement of existing work & personnel processes

• Contribution to a planned extension of the production area

Deliverables:

• Identified and fixed causes for low performances

• Delivered sustained plant efficiency of > 90%

• Reduction of sickness rate by ~30%

• Cleaned up compliance issues

• Supported a project team planning the execution of a production extension ahead

• Superior management for the production area of solids and softgel capsules for oral use in an environment in agreement with EU GMP classification Grade D to B

• Management of ~150 employees, with reporting line to the COO

• Further development and reorganization of the production area following an extended period of time without senior management

• Support and supervision of managers and employees in all topics

• Development and composition of new processes and forms in the areas of technical management, product development, bulkproduction, and packaging

• Analysis and optimization of outdated processes and procedures concerning the planning, research and manufacturing parts

• Linkage and coordination of existing and future processes and systems

• Preparation and design of the training documents

Deliverables:

• Led system upgrade from an operational perspective

• Planned and implemented process optimization considering SOP and GMP standards

• Cleaned up compliance issues

• Identified and fixed causes for low performances

• Closed gaps concerning EHS requirements

• Delivered sustained plant efficiency

• Reduced sickness rate by ~30 %