Scientist

1 week ago


Frederick, United States ClinLab Staffing Full time

Scientist / Sr. Scientist—Frederick, MD

Responsibilities:

• Participate and/or lead the development, optimization, qualification, and troubleshooting of analytical methods.

• Perform analyses of complex data sets.

• Support implementation of new instrument and evaluation of new instruments/technology.

• Execute analytical assay methods for routine sample testing to support lot release/stability testing for monoclonal antibody products.

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

• Participate and/or lead in transfer of methods to Quality Control Group.

• Author and review STMs, Protocols, and Reports.

• Mentor junior staff.

• Performs other related duties as assigned .

Required Skills/Abilities:

• Subject Matter Expert for Octet methods to determine kinetics of protein binding interactions.

o Experience developing novel kinetic methods a plus.

• Experience in ELISA, qPCR cell-based assays, and/or compendial methods (A280, pH, etc.).

• Hands on experience in protein analytics including assessment of potency and/or residuals .

• Strong understanding with method development guidance (ICH, FDA, EMA, USP).

• Experience with current Good Laboratory Practices (cGLP) and Good Documentation Practices (cGDP).

• Organized and self-motivated.

• Experienced in method development and/or qualification.

• Excellent time management and proven ability to meet deadlines.

• Excellent communication, presentation, and writing skills.

• Excellent organizational skills and attention to detail.

• Excellent time management skills with a proven ability to meet deadlines.

• Ability to function well in a high-paced and at times stressful environment.

• Familiarity with Microsoft Office Suite.

Education:

• Bachelors, Masters, or PhD diploma in life sciences.

• At least 7+ years (BS), 5+ years (MS), or 0 years (PhD) of industry, hands-on-experience with development and qualification of characterization/release assays for protein/DNA biological products.


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