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Smiling employee in a conversation with a colleague in the office
Smiling employee in a conversation with a colleague in the office
ID: 16904

Interim Head of Production

  • Pharma & Biotech
  • Asap
  • Process Development & Optimization, LEAN/Six Sigma
  • K-Recruiting GmbH
Contact:

Julius Strack

+49 89 1890998-614

julius.strack@k-recruiting.com

Overview

Availability
Asap, 5 days/week, on-site & remote
Qualification
Engineering/ Natural Sciences Lean Six Sigma Champion / PMP
Language Skills
German (native), English (business fluent)
Relevant Expertise
Head of Production & Manufacturing accord. to AMG, Bulk Production, Sterile & Aseptic Manufacturing, Vaccines, Process Development & Optimization, FDA, GMP, CAPA Management, Change Control, SOPs, Leadership & Coaching, LEAN/ Six Sigma, Pharma

Key-Facts

  • 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

Extract from previous activities

2021– date

Biopharmaceutical Company, Germany (via K-Recruiting)

Head of Production & Productivity Improvement Management (incl. vaccine production)

  • 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

2020 – 2021

Biopharmaceutical Company, Germany (via K-Recruiting)

Head of Production acc. to AMWHV (incl. vaccine production)

  • 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

2020

Biopharmaceutical Company, Germany (via K-Recruiting)

Head of Production (Bulk Production)

  • 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

2019 – 2020

Pharmaceutical Company, Germany (via K-Recruiting)

Head of Sterile Manufacturing

  • 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%

2019

Beverage Company, Part of a Business Group

Head of Manufacturing

  • 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

2018

Pharmaceutical Company, Germany

Head of Bulk Production

  • 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 %