2 days ago

Principal Scientist - Drug Product Development

Glenmark Pharmaceuticals S.A.

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Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology. 

Glenmark’s biologics research operations in Switzerland focuses on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a complete suite of end-to-end, in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as upstream and downstream development.


Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

Principal Scientist - Drug Product Development

Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology. 

Glenmark’s biologics research operations in Switzerland focuses on the discovery and development of new biological entities from inception through preclinical and clinical studies. With a world-class, GMP-certified manufacturing line, our Swiss site located in the canton of Neuchâtel is well-positioned to fully serve the company’s growth in biologics research and development. The facility provides Glenmark with a complete suite of end-to-end, in-house capabilities necessary for early production of investigational biologics medicines, including cell line development, bioassay development and antibody engineering, as well as upstream and downstream development.


Glenmark is a rapidly growing company with many exciting and challenging career opportunities. We continue to recruit talented professionals who would like to contribute to our success and who share our values of respect, knowledge and achievement.

RESPONSIBILITIES:


  • Manage drug product development team (late stage activities) including overseeing professional development, education, coaching and training, with continuous focus on improving working processes.

  • Manage activities relevant to drug product manufacturing (mixing studies, filtration studies, extractable/leachable studies etc.) for Glenmark’s NBE and Biosimilar products.

  • Actively contribute to relevant part of section 3 of IND/IMPD’s. 

  • Select and finalize clinical trial material by performing compatibility studies for different regions (USA, EU, etc). 

  • Interact with CMOs/CROs for drug product development during different phases of product development.

  • Responsible for technology transfer from the drug product development group to Technical Operations team in Glenmark or to external CMOs.

  • Prepare documentation and operational input to facilitate IMP management for clinical trials of Glenmark’s NBE and Biosimilars.

  • Manage long-term stability studies.

  • Oversee day-to-day laboratory management.

  • Manage technology assessment and development studies appropriate for Glenmark’s drug product development needs.

  • Interpret and report results of work carried out in written and oral format both internally and externally.

  • Evaluate external developments in the area of drug product development and make recommendations based on their applicability for Glenmark’s projects.

  • Perform other relevant duties as required.

 


REQUIREMENTS:


  • PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 6 years industrial experience

  • Significant experience in protein formulation for both early and late phase development 

  • Experience with regulatory submissions in USA/EU for sections relevant to drug product development/manufacturing 

  • Experience in technology transfer and management of drug product manufacturing

  • Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment) 

  • Ability to manage a team and work independently within the group as well as within teams crossing disciplines and functions

  • Fluency in English, both written and verbal; French is a plus

  • Excellent communication skills and strong diplomacy skills required

 

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