What are the responsibilities and job description for the Scientist- CMC Analytical Development position at Integrated Resources, Inc ( IRI )?
Duration: 6 months
Note: The manager is seeking candidates with a focus on peptide/protein CMC analytical development and antibody characterization experience and focused on LC and LC-MS.
Responsibilities:
- Develop, qualify, and troubleshoot chromatographic (GC, HPLC/UPLC) and LCMS based methods for the identification, characterization, and impurity profiling of oligonucleotides, siRNAs, and their formulations, as well as raw material related analytical methods and other methods as needed.
- Understand and apply advanced scientific principles, theories, concepts, practices and standards to process and analytical development.
- Provide analytical support for investigations leading by quality, manufacturing, supply chain.
- Perform testing of late development siRNA candidates and their formulations for their characterization.
- Author method development and qualification reports and SOPs for test methods. Evaluate suitability of new methods and oversee method qualification and validation in the external contract testing labs.
- Author and review analytical sections in regulatory submission documents.
- Apply strong technical knowledge of organic and analytical chemistry to support laboratory investigations (deviations/OOS/OOT), as needed.
- May serve as a primary contact person for cross-departmental needs or projects and be accountable for key deliverables.
- Contribute to the development and/or improvement of technical capabilities as well as initiatives to improve department efficiency.
Qualifications
- PhD in Chemistry, Biochemistry or related disciplines with 0-4 years industry experience, Master’s degree with > 5 years related industry experience or Bachelor’s degree with > 8 years related industry experience respectively, with demonstrated chromatographic separation, method development / qualification and structure elucidation expertise.
- Experience with HPLC/UPLC and LCMS-based analytical method development desired.
- Hands-on experience with oligonucleotides, proteins, or peptides is a plus.
- Familiarity with instrument troubleshooting and software including Empower, MassHunter, and UNIFI preferred.
- Knowledge of GxP requirements and application of statistical methods in the analytical laboratory is a plus.
- Strong interpersonal skills, communication, and collaboration.
Salary : $65 - $70