\\n Salary: Highly Competitive

• Job type:

Permanent * Discipline:
Genetics & Genomics * Location:
Switzerland

Vaud, Switzerland

Posting date: 16 Jan 2024

Reference: 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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