- Review of Biologics bioanalytical data (notebook documentation, raw data, and LIMS data) for accuracy, consistency, and completeness to ensure compliance with SOPs and GLP.
- Review method development/qualification/validation reports and sample analysis reports including text and data for accuracy and consistency.
- Preparation of bioanalytical test result data tables for clinical testing reports. Review of client data transfer specifications. Prepare and transmit client data transfer tables. Other duties as assigned.
- Bachelor's degree in chemistry, biochemistry, immunology, or another related scientific field.
- Quality control or quality review/audit experience within a biotech/CRO/pharmaceutical or laboratory environment
- Proficient in Microsoft Excel.
- Experience working in a regulated GMP/GLP environment
- Experience working with the Watson LIMS system is a plus
- Working knowledge in the use of ligand binding methods (ELISA, MSD, Gyros)
- Familiar with PK, ADA, and Biomarker data generated via ligand binding assays
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QC Specialist-Large Molecule
3 weeks ago
Frontage Laboratories Exton, United StatesJob Description · Job Description · Quality Control Specialist-Large Molecule · Exton, PA (Corporate) · Frontage Laboratories · Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the d ...
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QC Specialist-Large Molecule
2 weeks ago
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Frontage Laboratories Exton, United StatesJob Description · Job DescriptionTitle: Senior method development scientist-Large Molecule Bioanalysis by LC-MS/MS · Location: 700 Pennsylvania Dr. Exton, PA · Reports to: Executive Director, Bioanalytical Services · Full-time/on-site · Frontage Laboratories Inc. is an award winn ...
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Johnson & Johnson Malvern, United StatesJob Description · Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Staff Engineer, Large Molecule Drug Product Development & Delivery, located in Malvern, PA. · About Johnson & Johnson · At Johnson & Johnson, we ...
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GlaxoSmithKline Collegeville, United States Full timeSite Name: USA - Massachusetts - Waltham, Upper Providence · Posted Date: May · JD - Senior Manager, Analytical Development, SED · As a Senior Manager of Analytical Development, you will join a team of scientists responsible for managing analytical activities throughout developm ...
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Scientist-Biophysics
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Field Technician
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Scientist
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Senior Scientist
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Scientist - Immunogenicity
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Senior Scientist
3 weeks ago
Frontage Laboratories Exton, United StatesJob Description · Job DescriptionSenior Method development scientist-Biomarker LC-MS/MS · Title: Senior method development scientist- Biomarker LC-MS/MS · Location: 700 Pennsylvania Dr. Exton, PA · Reports to: SVP, Central Lab, Biomarker, and Biologics Services · Full-time/on-sit ...
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Scientist
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Associate Scientist/scientist
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Associate Scientist/Scientist
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Senior Scientist- Biologics
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Associate Scientist/scientist
2 days ago
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Senior Scientist- Biologics
3 weeks ago
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Director Product Development
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Frontage Lab Exton, United StatesScientist/Senior Scientist - Pharmaceutical Analysis - Large Molecule · Exton, PA (Research) · Roles and Responsibilities: · * Develop and apply biochemistry, biophysics methods, immunoassays, and other state of the art analytical technologies to analyze and characterize oligonuc ...
QC Specialist-Large Molecule - Exton, United States - Frontage Lab
Description
Quality Control Specialist-Large MoleculeExton, PA (Corporate)
Frontage Laboratories
Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals.
We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA, and 505(b)(2) submissions in global markets allowing for the successful development of important therapies and products for patients.
We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets. Come and join us to make a world of difference.Responsibilities
All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
