Are you ready to make a true impact at a growing biotech company?

Our client is seeking a highly motivated individual with an entrepreneurial spirit for an open position to support a large vaccine development program. They are an established organization that focuses on the development and manufacturing of high-value biosimilars, biodefense medical countermeasures, and client-selected novel drugs using its patented biomanufacturing platform. We are seeking motivated individuals with an entrepreneurial spirit to join their biopharmaceutical development team.

We are looking for highly qualified candidates with a bachelor's or preferably a master’s degree in the life sciences with relevant skills and 4 + years of bench experience in an industry setting. The level of this position will be commensurate with the candidate’s work experience.

A minimum requirement of at least four years of hands-on experience with protein and DNA biological product assays (qPCR, Octet/SPR, cell-based assays, and ELISA).

The selected candidate will participate in the development and qualification of a variety of assays for ensuring product quality. In this position, the candidate will be responsible for the execution and analysis of experiments using various techniques in protein and process residuals analysis.

Responsibilities

• Performing bioanalytical assay methods for lot release/stability testing for monoclonal antibody products, including A280, Appearance, cell-based assays, ELISA, qPCR, and SPR
• Performing analyses of complex data sets
• Participating in the development, optimization, qualification, and troubleshooting of analytical methods
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner
• Writing and Reviewing STMs, Protocols, and Reports
• Participating in the transfer of methods to QC

This is an excellent opportunity to gain valuable experience with an innovative, small, young Biotech company and build a career in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential, high reward environment and be able to work overtime and weekends as project needs are determined.

Minimum Qualifications:

• Bachelor’s/Master’s degree in life sciences
• Experience with current Good Laboratory Practices (cGLP) and Good Documentation Practices (cGDP)
• Hands-on experience in cell culture and protein analytics (minimum 2-4 years) including testing for potency and residuals
• Experience with method qualification
• Familiarity with Guidance (ICH, FDA, EMA)
• Ability to collaborate with peers on day-to-day tasks; cooperative and works well with a team to ensure timelines are met.
• Strong attention to detail
• Excellent time management and proven ability to complete projects on time
• Must be organized and self-motivated
• Must have excellent communication, presentation, and technical writing skills
• Knowledge of automated liquid handling systems and sample management (LIMS) is a plus
• Proficiency with Microsoft Office (Word, Excel and Powerpoint etc.)
• Must love to learn!