We are hiring a Production Specialist!

We are hiring a Production Specialist!


Essential Duties and Responsibilities include, but are not limited to, the following:

  • Operate in the manufacture of biologic drug products for pre- clinical studies and clinical trials (upstream, downstream and fill & finish)
  • Writing of IQ (installation qualification)/OQ (operational qualification)/SOPs for equipment and production techniques as needed
  • Batch Production Record (BPR) preparation, organization and revision
  • Identification and Investigation of product/process deviations (DEV, OOS and CAPA)
  • Training of Production personnel


Basic Qualifications:

  • Degree in Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biochemistry or related sciences
  • 7+ years of GMP production experience


Highly desirable skills:

  • Good knowledge of international and national guidelines applicable to production (namely GMP)
  • Knowledgeable in downstream techniques with special focus on chromatography
  • Cleanroom Class A, B and C manufacturing operations under GMP environment
  • Experience in process development and Tech Transfer is a plus
  • Experience with biologics manufacturing techniques (e.g. antibodies)
  • Experience with FDA and INFARMED inspections is a plus
  • Strong interpersonal skills
  • Excellent written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
 

 

Please send CV to vectorb2b.hr@gmail.com