SEC Recruitment: The Principal Scientist / Senior Scientist


The Principal Scientist / Senior Scientist

My client an international company based in Ireland is looking for a Principal Scientist/Senior Scientist to join their manufacturing site.

Accountabilities/Responsibilities:

Promote scientific rigor in defining and understanding biotherapeutic product profile, provide protein analytical expertise and increase process knowledge.

The focus of this scientist is to understand the fundamental mechanism/s of protein instability, sub-visible particulate formation and aggregation using a variety of chromatographic, biophysical and biochemical techniques, as well as predictive modeling tools.

The scientist will have advanced expertise in a number of analytical technologies used to test peptides and proteins.

Apply and Share in depth knowledge of a number of the following areas with the group; glycosylation characterization, antibody / protein primary structure characterization, Higher order structure properties/characterization such as secondary, tertiary and quaternary structures, Post Translational Modifications characterization, for a range of therapeutic proteins, including monoclonal antibodies and novel protein formats.

Contribute to the development of strong predictive models to understand in depth the chemical and physical basis of Large Molecule drug product degradation thus providing an efficient and scientific basis for setting shelf-life and to gain understanding of stability challenges.

Troubleshoot analytical methods to be utilized in elucidation of product variants to characterize protein degradation pathways.

Provide scientific support to projects analyzing protein stability from early to late development phase by employing predictive stability models and biochemical characterization of peptides/ proteins to assess the impact to shelf-life and to increase product knowledge. Evaluate data generated and communicate the interpretation and implication of results.

Coordinate specialized analytical testing and generation of technical documents to support regulatory filings

Ensure that continuous improvement/lean methodologies are integrated in stability protocol design.
Ensure compliance with regulatory requirements (FDA, EMEA, ICH etc.),cGMP and safety regulations.
Participating in relevant internal and external clinical release and stability related audits.

Represent Clinical Release and Stability where appropriate in meetings and other communications with regulatory authorities. Drive innovative solutions or studies to address regulatory questions and product related issues.

Remain current with scientific literature with regard to protein characterization, degradation and associated analytical methodologies and actively apply new concepts as appropriate.
Evaluate new cutting-edge technologies for protein product analysis, focusing on product heterogeneity and impact on shelf life/expiration stability.

They will provide strong technical and strategic leadership, effectively manage a multi-project development portfolio and make strong technical and strategic contributions to multi-disciplinary/ cross-functional development project teams so as to ensure efficient and timely execution of deliverables

Education and Experience:

Advanced scientific degree (Ph.D. or M.Sc.) with strong expertise in Biochemistry, Biology, Molecular Biology, Biophysics, Chemistry, Pharmacy or closely related disciplines is preferred

Good working knowledge of protein chemistry and structure and biochemical/bioanalytical methods for cGMP testing of biopharmaceuticals gained in either an academic or commercial environment.

An excellent knowledge of analytics, stability and specifications or equivalent and at least 5 years of experience in a development/technical role in the Biotech Industry/Academia is required.

Hands On experience and a strong understanding of a number of the analytical techniques and underlying principles of protein/peptide characterization to assess composition, purity, degradation and potency is essential (e.g. SDS-PAGE/cSDS, IEF/ cIEF, SEC/RP/IEX HPLC/UPLC, ELISA, Bioassay, qPCR and Western blot, calorimetry, spectroscopy (CD, fluorescence, UV/VIS, and FTIR), and the detection of sub-visible particles, higher order structure analysis, protein mass spectroscopy and carbohydrate/glycan analysis).

Knowledge or experience in designing and executing forced degradation studies and/or deploying predictive modeling tools in Large Molecule stability approaches to establish/understand protein structure -function relationships would be a plus.

Comprehensive understanding of cGMP, pharmacopeia testing and regulatory requirements for filing and registration of biologics.

If you are interested in this new opportunity, please send your CV and availabilities to Alexandre De Gennaro at alexandre.degennaro@secpharma.com and I will contact you for a confidential conversation.

Alexandre De Gennaro
Pharmaceutical Division, R&D and Quality Control
Tel: +44 (0) 207 255 6665
Alexandre.degennaro@secpharma.com

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