Job Type: Permanent
Specialism: Analytical Skills Development & Manufacturing Report – Writing
Industry: Large Molecule
Salary: $95000 - $120000
Location: USA
ClinicalPro is seeking an Associate Principal Scientist for a leading organisation specialising in large Molecule research located in the USA.
This individual will be responsible for creating and approving analytical techniques to support regulatory research. The individual will be in charge of managing sample analysis on preclinical and clinical specimens.
Must be eligible to work in the USA.
Responsibilities
- Work in diverse teams.
- Oversee internal and contract research organisation (CRO) PK/TK and toxicological studies under little supervision.
- For in vivo research, act as the sponsor representative, the study director/investigator, and the principal investigator/contributing scientist, and may write and format the protocols, reports, and supporting documentation.
- Support data import, transfer, and input from CROs into client company’s systems; independently handle research paperwork transfer between CROs and the client company.
- Management of research sample logistics, including delivery to and pickup from CROs.
- Analytical and non-clinical results should be checked for completeness and conformity with the research protocol, SOPs, and any relevant laws and regulations.
- For reports and regulatory filings, extract, combine, and tabulate data from paper and electronic sources.
Skills and Requirements
- Extensive experience in the design and execution of biologic mass spectrometry, with a focus on big molecule modalities, including sample preparation, mass spectrometer operation, and data processing.
- Extensive familiarity with LC-MS/MS platforms.
- Proficiency in quantitative analysis and studies tracking many reactions.
- Advanced understanding of informatics systems and data analysis software for mass spectrometry.
- A thorough grasp of the creation of biologics, covering a variety of modalities such peptides, ADCs, ADAs, oligonucleotides, and siRNAs.
- Excellent communication abilities, as shown by papers and talks in high-impact scientific fields.
- Write technical reports, scientific presentations, and sections and replies to regulatory submissions.
- To enhance mass spectrometry, research and create new technologies.
- Plan and carry out experiments.
- Multitasking, prioritisation, and problem-solving abilities.
Apply
If you’re interested in this position, apply now to send us an updated copy of your CV, or give us a call right away.
To explore more opportunities, visit Opportunities at ClinicalPro