Director, Product Characterization/Annlytical Department at Boston

Job Description

Director, Product Characterization

Description
This position is within the Protein Analytical Sciences (PAS), which is responsible for developing methods for characterization of therapeutic protein drug candidates, hands on development experience with LC-MS and LC-MS/MS. We are seeking a motivated and experienced candidate with advanced degree in chemistry, analytical chemistry, biological sciences or related field, who exhibits a broad analytical aptitude and can function as a leader in a highly collaborative multidisciplinary team environment to perform characterization of proteins and peptides using state of the art LC-MS and LC-MS/MS based techniques and some other biophysical methods.

Key Objectives/Deliverables

• Utilizing LC-MS techniques to analyze proteins and peptides to support therapeutic protein drug discovery and development
• Performing intact mass and peptide mapping analyses of proteins and peptides
• Operating, maintaining and troubleshooting of liquid chromatography, mass spectrometers and auxiliary instruments
• Designing and performing experiments, reviewing and analyzing data, and independently interpreting experiment results for qualitative and/or quantitative analyses of degradation and post-translational modifications (PTMs) of protein samples.
• Presenting analytical results at group/project team meetings. Writing analytical reports and updates to customers.
• Manage a group of four scientists and provide technical supervision

Basic Qualifications:

• MS with 10+ years/, or PhD with 6+ years of relevant experience as demonstrated by hands-on experience in protein analysis with LC-MS technique.
• Knowledge of protein chemistry including PTMs and degradation pathways.
• Understanding of LC-MS methods in protein characterization and hands-on experience in intact mass analysis and peptide mapping analysis of proteins.

Job Function:Analytical Development
Primary Location:China Shanghai

Job Requirements

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Director/Senior Director, Analytical Development

Description

This position is within the Protein Analytical Sciences (PAS) and located in the Wuxi city, China. The Director/ Senior Director is responsible for managing a PAS team to provide analytical support for cell culture and purification process development, process characterization, tech transfer and cGMP clinical manufacturing.

Qualifications:

MS or Ph.D. degree in a relevant biopharmaceutical science discipline with 8+ years of industrial experience in the fields of biologics analytical release and characterization assay development, qualification, validation and transfer

Demonstrated record of accomplishments and in depth technical experience in the biologics analytical assay development intended for clinical trials and commercialization. Must be able to work in a team-oriented manner in order to accomplish objectives.

Must be proficient with the requirements of the FDA/EMA cGMP regulations, ICH guidelines. Familiarity and understanding of the CFDA cGMP regulations preferred.

Excellent written and verbal communication, negotiation, problem solving and decision making skills, and outstanding interpersonal skills

Demonstrated leadership and capability for strategic analysis and conflict resolution, organizational and project management skills preferred.

Primary Location:China Wuxi

Country: USA, State: Massachusetts, City: Boston, Company: Wuxi Apptec.