Our client is seeking highly motivated applicants with an entrepreneurial spirit for an open position to support our biopharmaceutical development programs.

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

• A minimum requirement of at least two years of hands-on experience with protein biological product assays (HPLC, CE-SDS, cIEF, Immunoassays, or cell-based assays).
• Other relevant skills include SDS-PAGE, IEF, ELISA, Octet/SPR, and qPCR.
• Knowledge of automated liquid handling systems and sample management (LIMS) is a plus.

The selected candidate will participate in the 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 and may be involved in some assay development activities when needed.

Responsibilities:

• Performing QC assays methods (ELISA, HPLC, CE, UV-Vis, qPCR, Endotoxin)

• Lot release/stability testing for monoclonal antibody products

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner

• Writing and Reviewing Quality Control Documentation

• Assist in OOS and CAPA investigations

• Writing of Deviations and Change Controls as needed

• Participate in transfer or qualification of methods in 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 fast-paced, 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 Manufacturing Practices (cGMP) and/or Good Documentation Practices (GDP), preferably in a QC setting

• Hands-on experience in protein analytics (minimum 2-4 years) including HPLC, CE and/or immunoassays

• 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

• Proficiency with Microsoft Office (Word, Excel, Powerpoint, etc.)

• Must love to learn!

Benefits:

Our client offers a competitive salary and benefit plan including health insurance (medical, dental & prescription), health savings account and a retirement plan with employer match.