Biotechnology company is hiring a Scientist to manage method development, optimization, qualification/validation, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for our projects. This is a 12-month contract.
Responsibilities
- Execute technical analytical methodologies to support development and qualification/validation of test methods.
- Assist in writing and reviewing of analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control where needed.
- Operate, maintain, and install sophisticated analytical instrumentation and associated computer control systems.
- Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development.
- Provide support for laboratory operations – inventory tracking, reagent/solution preparation, sample management, and documentation review.
- Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
- Ensure adherence to GxP guidelines where required.
- Occasional weekend work may be needed based on timelines.
Qualifications
- Masters degree with 6+ years of industry experience; PhD with 4+ years of industry experience.
- Expert level understanding of LC-MS/MS and MALDI.
- Working knowledge and experience performing analytical assay techniques such as absorbance (UV) assays, SDS-PAGE, ELISA, liquid chromatography ((U)HPLC), mass spectrometry (LC-MS and/or MALDI), CE-SDS, icIEF.
- Experience following protocols and SOPs.
- Be able to fluently communicate across technical and operational activities and work collaboratively to ensure successful execution.
- Working knowledge of statistics.
- Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
- Self-motivated, proactive and driven individual with an interest in experimental design and development.
Salary
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
