Position Code: 23032-19U
The senior Scientist/Scientist of Analytical Sciences will support the Gossamer Bio CMC Department. This individual will contribute to the development and establishment of various analytical techniques across all projects as necessary. In addition, the scientist will provide hands-on support to the product development and/or process chemistry team in the laboratory.
- Assists in the development and/or improvements of analytical techniques at the CMOs or CROs. This includes all drug substances and drug products methodologies.
- Evaluates existing analytical techniques across all projects and performs improvements if necessary.
- Leads the transfer of test methods to CMOs’ or CROs.
- Summarize experimental findings, reviews and interprets study results, assembles analytical data packages.
- Reviews and approves analytical data, technical protocols/reports and analytical methods.
- Develops stability-indicating HPLC or UPLC methods to support across all projects.
- Resolve complex method development challenges through collaboration with the process chemistry and product development team.
- Performs routine maintenance and troubleshooting of HPLC/UPLC as well as other analytical techniques.
- Trains others on a variety of analytical techniques including, but not necessarily limited to: analytical balances, pH meters, high performance liquid chromatography (HPLC/UPLC), UV/Vis spectroscopy, GC, dissolution, Karl Fischer, disintegration, DSC, TGA, PSD, PXRD, hardness, and friability testing.
- Plan and coordinates laboratory studies. This includes the stability testing of development compounds and formulations.
- Maintain complete and accurate records of laboratory work in conformance with company SOPs and training.
- Evaluate and leads implementation of new improved processes within Analytical Sciences for delivering high quality CMC information to agreed timelines.
- Maintain up-to-date knowledge of applicable industry and regulatory guidelines and requirements
- Assist in the creation and/or revision of Standard Operating Procedures.
Experience & Education
- BS degree in physical or biological science with 7+ years of experience in the pharmaceutical/biotechnology industry or MS with 7+ years of experience in the pharmaceutical/biotechnology industry
- Small molecule and drug product method development experience is required to be considered. HPLC/UPLC method development experience and early phase knowledge must have
Other Skills and Abilities (Required):
- Ability to interpret analytical data and draw conclusions
- Able to analyze, summarize and present data to the stakeholders or decision makers
- Demonstrated ability to work on multiple projects and meet timelines
- Knowledge of current analytical methodologies
- Strong written and verbal communication skills
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected].