Job Detail

Scientist, Drug Product Process Development

Inseriert am: 19.03.2019
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At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 


Our vision :


We strive to be the leading supplier using science and technology to improve the quality of life.


Our mission :


We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 


Do you want to help us as we shape the future of this great organization?


 


Job Description Summary


For Lonza Drug Product Services (DPS) we currently have multiple opportunities available in Process Development. Become part of this exciting opportunity and join our team by applying for the position as Scientist, Process Development.


This position supports Process Development for all projects in Drug Product Services involving biologics and small molecule and peptide parenteral products. The Scientist, Process Development will also support manufacture of pre-clinical as well as clinical drug product supplies.


Key accountabilities and duties



  • Assist in establishing Drug Product process development infrastructure and services for parenteral drug products for clinical and commercial use.

  • Install, qualify, and maintain equipment for process development, non-GMP manufacturing and related analytics in close alignment with current best practices and regulations.

  • Plan with supervision and perform process development and characterization studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats, ADCs, peptides), peptides and small molecules including freeze/thaw studies, pooling, filtration and mixing studies and scale down modelling of filling and lyophilisation processes.

  • Analyse lyophilized samples by associated methods (cake appearance, BET surface analysis, DSC, residual moisture by Karl Fischer, reconstitution time) including analysis of pre-lyo material by freeze-drying microscopy and low temperature DSC.

  • Support analytical testing of generated process development liquid product samples including HPLC, CE purity methods, protein content by UV, identity, color, clarity and opalescence, pH, osmolality, visible particles, subvisible particles).

  • Document data following applicable lab procedures and current documentation practices. Evaluate results and summarize in short reports.

  • Ensure safety and health protection following lab and safety instructions

  • Evaluate and implement new methods and technologies, as required. Contribute to innovation, technical strategy projects and scientific publications.

  • Manufacture non-GMP drug product samples for supportive stability studies and preclinical use (e.g. GLP tox studies) applying aseptic working techniques .


Qualification and Skills required



  • Master’s Degree in a relevant discipline, e.g. Pharmaceutical Sciences, Chemical or Biochemical Engineering, or a training on the job as lab technician

  • At least 2 years of experience as a Research/Technical Assistant in the Pharmaceutical or Chemical industry, preferably in pharmaceutical development or manufacturing environment

  • Working experience in relevant pharmaceutical development and manufacturing technologies with additional theoretical and hands-on experience in freeze-drying is an advantage.  Experience with  parenteral dosage forms, protein formulation and analytics and aseptic working techniques is a plus

  • Good reporting and documentation of scientific results

  • Excellent communication skills in English

  • Ability to work independently and in a team environment

  • Detail oriented, strong inter-personal skills

  • Enthusiastic and open-minded

  • Willingness to learn and carry out new and complex tasks

  • Proactive attitude


 


 


Lonza.  The place to Go, Stay and Grow.

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