Full Job Description
Director - Industrialization
This role is responsible for managing all the activities needed to ensure the new products/processes transfer to production, and/or the technical support and/or improvements to existing products and processes in an optimal quality, cost and time manner.
Manages and develops a team of technical staff, engineers (including sub-contractors) and managers to reach the quality, cost and timeline projects’ objectives: organization, methodologies, competencies, human and material resources (workload/capacity consistency).
Is responsible for budget (staff, OPEX, CAPEX), cost reduction, quality, regulatory and safety compliance of the department. Analyses of data and set up action plans to improve performances.
Supervises the different projects managed by the industrialization staff such as new products transfer to production, technical support, product/process improvements, and engineering or cost reduction projects.
Contributes to the management of the site as part of the Site leadership team: day to day and mid/long term management (e.g. development of site’s LRP Long Range Planning for Manufacturing)
Represents the site in relation with other sites or Corporate departments (GMS, Purchasing, etc.) to participate in corporate projects such as manufacturing site transfers, due diligence,etc.
B. S. or M.S degree in a chemistry or biochemistry or related field is desired.
A minimum of 12 years of working experience in cGMP regulated and ISO certified environments. Prefer industrial experience with LC Mass Spectrometry (LCMS), HPLC, and UV. (Educational experience may be considered in lieu of industry experience.)
Must have computer skills including Microsoft Office (MS Excel, MS Word, and MS PowerPoint) and Microsoft Outlook.
Knowledge of experimental design (DoE), design controls, quality systems, and laboratory safety. Previous experience in environments is desired. Good laboratory technique and safe operation of lab equipment are essential skills.
Must display good problem solving ability, written communication skills in English, and possess strong organizational skills.Experience in and/ or knowledge of working in a manufacturing environment. In particular, a device regulated manufacturing facility.
Working knowledge and experience performing RCA utilizing the proper RCA tools.
Clinical Microbiology and or Pharmaceutical Microbiology experience relating to dug/organism interactions is desired
Working Knowledge of FDA guidance documents for performing RCA along with regulatory compliance expectations
Lifting (up to 25 lbs) office products and supplies and moving containers of various materials.
Operating within cool temperature and low humidity conditions within the production room.
Constant noise is common due to the operation of the air-dry chamber, taping and pouching equipment.
Excellent personal hygiene required.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA