Principal Scientist - Analytical Development (CMC) job in Vaud, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Genetics & Genomics

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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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