Principal Scientist - Analytical Development (CMC)

Highly Competitive
  1. Permanent
  2. Genetics & Genomics
  3. Switzerland
Vaud, Switzerland
Posting date: 16 Jan 2024
58309

Proclinical are recruiting for a Principal Scientist - Analytical Development (CMC) to join a pharmaceutical organisation. This role is on a permanent basis.

Responsibilities:

  • Offer crucial knowledge in the development of the company's ADC.
  • Partake in the biotech programs method in a matrix setting with the view to speed time to clinic.
  • You will plan stability studies and outline shelf-life of GMP products, review and characterise impurities, etc.
  • Produce crucial data to assist with protein characterisation and comparability studies.
  • Responsible for preparing, evaluating, filing of analytical CMC source documents for clinical trial application, serving as a support to CMC regulatory affairs.
  • Contribute to the selection of pertinent CDMOs/CROs by evaluating the suggested analytical packages.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to an advanced degree level in a biochemistry, analytical chemistry, or a similar discipline with pertinent industry experience within biologics R&D.
  • Demonstrable experience within a biotech manufacturing organisation in numerous stages of project development, working in practical analytical development as well as in multidisciplinary teams.
  • A background in development and validation strategies of analytical characterisation, CE, mass spectrometry, bioassay of antibodies, and ADCs.
  • Familiarity with large molecule and protein characterisation.
  • Prior involvement with comparability studies.
  • Comprehension of the international development of biologicals from preclinical to late-stage clinical development.
  • Comprehension of the management of a network of CDMO's and CRO's.
  • Expertise on regulatory and quality guidelines suitable for investigational medicinal products and biologics.
  • A scientific curiosity and flexible with the ability to resolve multifaceted scientific issues.
  • A high attention to detail.
  • Interpersonal and communication skills both verbally and in writing.
  • Works well with others in a team.
  • Capable of distributing multifaceted goals under challenging timelines within a swiftly changing setting.
  • Resilience abilities.
  • Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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