Senior Scientist, Analytical Development -Biologics (REMOTE)
Company: GQR Global Markets
Posted on: January 16, 2022
Position Summary: We are seeking a Senior Scientist, Analytical
Development to join our Analytical team.Position can be fully
Lead and support Analytical Development activities related to
analytical method development, product characterization and
comparability assessment for multiple early-stage and late-stage
programs of ADCs, mAbs and fusion proteins. This role will report
to the Director of Analytical Development.
- Work in a team environment to manage and co-ordinate analytical
development activities between contract testing labs, CMO and
- Develop, improve, and implement platform methodology for
release/stability and characterization testing for our
- Manage product characterization and analytical comparability
- Author and review analytical documents including but not
limited to protocols, reports, procedures and certificates
- Write and review analytical sections in regulatory submission
documents (e.g. IND, IMPD, BLA)
- Work closely with Quality Control in analytical method
implementation, qualification/validation, and transfer. Serve as a
technical expert to aid in analytical investigations and assay
trouble shooting in routine GMP Quality Control testing.
- Be a key member of the interdisciplinary CMC project teams.
- Bachelor's degree required. Prefer candidates with a Master's
and/or PhD in Biochemistry, Chemistry, a BS/MS degree
- 5+ years of industry experience in (bio-) pharmaceutical
manufacturing and testing
- 5+ years' experience in Mass spectrometry, chromatography (e.g.
SEC, RP-HPLC, IEX), and capillary electrophoresis (e.g. icIEF,
CE-SDS) techniques for protein therapeutics
- Experience with structural characterization of both large
and/or small molecules
- Experience in analytical method development and
qualification/validation for GMP quality control testing
- Experience with antibodies, highly potent cytotoxic active
pharmaceutical ingredients and/or antibody-drug conjugates is a
- Hands-on experience with outsourcing of assay development,
stability and quality control in support of CMC activities
- Knowledge of regulatory environment (ICH/FDA/EMA regulations)
and experience with organizing and writing regulatory
- Excellent communication skills for both written and verbal
- Strong and proven leadership capabilities related to project
- Self-motivation, enthusiasm and ability to interact within a
multi-disciplinary team across multiple locations.
Keywords: GQR Global Markets, Nashville , Senior Scientist, Analytical Development -Biologics (REMOTE), Other , Nashville, Tennessee
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