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