Position Code: 23056-19U
The Manager of Analytical Sciences will support the Gossamer Bio CMC Department. This individual will lead the analytical activities for one or more projects and will work closely with CMOs and CROs . He/she will effectively deliver analytical data to the project teams and is responsible for the CMC sections of regulatory submissions. A strong team player with the ability to communicate and collaborate in an interdisciplinary environment is essential.
- Acts as the analytical lead for both drug substance and drug product for one a more projects.
- Interacts with CMOs/CROs as well as internal inter-disciplines to ensure timely delivery of the analytical data.
- Plans and coordinates analytical related studies. This includes the stability testing of development compounds and formulations, formulation development support.
- Manages analytical method development, validation and transfer activities as well as extended characterization assays.
- Resolves complex method development challenges through collaboration with the process chemistry and formulation development team.
- Proposes and justifies specifications for drug substance and drug product.
- Reviews and approves analytical data, technical protocols/reports and analytical methods.
- Manages or supports investigations, change controls and CAPAs as required
- Summarizes experimental findings, reviews and interprets study results, assembles analytical data packages.
- Supports quality and regulatory teams to provide relevant documentation & draft sections of regulatory filings
- Maintains productive relationships with team leaders and contract organizations to ensure high quality data is shared and communicated effectively in a timely manner.
- Maintains up-to-date knowledge of applicable industry and regulatory guidelines and requirements
- Authors and reviews SOPs related to multiple functions.
- Manages and trains Analytical Sciences staff, particularly with respect to new processes and procedures as well as changes in processes and systems
Experience & Education
- BS in Analytical Chemistry with 7+ years of experience in the pharmaceutical/biotechnology industry or MS with 5+ years of experience in the pharmaceutical/ biotechnology industry.
- A minimum of 3 years of experience managing CMOs or CROs.
Other Skills and Abilities (Required):
- Experience with all phases of product development
- Thorough knowledge of GLPs and GMPs as they relate to pharmaceutical development
- Experience working with and managing third party vendors.
- 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
- A good understanding and knowledge of US and international regulatory requirements (ICH Quality Guidances)
- Knowledge of current analytical methodologies
- Strong written and verbal communication skills.
- Willingness and ability to travel (10 to 25%)
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].