Senior Scientific Associate New Manufacturing Unit (897257-ED)

Location
Canton of Basel-Stadt (CH)
Salary
competitive
Posted
02 Feb 2021
Closes
04 Mar 2021
Discipline
Manufacturing, R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Senior Scientific Associate New Manufacturing Unit (897257-ED)

 

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a Senior Scientific Associate for a permanent contract based in Basel area.

The ideal candidate should have more than 3 years of previous experience in the pharmaceutical industry within formulation development and GMP manufacture environment. Also understanding of microbiology and technical knowledge in liquid filling and aseptic practices are strongly recommended.

Main Responsibilities:

You will be part of a new clinical manufacturing unit to support in-house development and manufacturing of sterile liquids and semi-solids dosage forms. Thus you will participate in activities supporting the Manufacturing unit readiness   (e.g. validation’s activity including room qualification, equipment IQ/OQ/PQ, media simulation, etc.)

Your main tasks will consist in :

  • Drafting SOP and review of relevant documentation link to the new facility
  • Finding the Formulation and manufacturing process development of liquid forms under aseptic conditions/Planning and execution of experiments and IPC tests
  • Manufacturing batches and documentation of the manufacturing process according to cGMP for clinical trials and beginning of commercial
  • Writing technical development documentation, incl. the first assessment of the results; support drafting of master batch records, archiving
  • Doing the operation / cleaning of rooms and equipment according to SOPs
  • Contributing to manufacturing and cleaning procedures, reports and instructions and / or SOP's and to the evaluation of new manufacturing or lab equipment
  •  Supporting inspections by internal or external authorities

 

 

 

 

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • Bachelor's degree in pharmacy / chemistry with minimum 3 years of industrial experience or Education as a laboratory technician, with more than 5 years of experience in pharmaceutical formulation development combined with cGMP manufacture. Knowledge in microbiology is an advantage.
  • Profound technical knowledge in liquid filling (syringes and vials) and aseptic practices
  •  Solid experience in optimizing existing processes and contributing to new process development
  • Good know-how of technical tools along with sufficient knowledge of software and computer tools
  • Fluent English both written and spoken
  • Ability to work with multi-disciplinary team including external suppliers and scientists
  • Readiness to work in cGMP environment in grade A and B