Position Code: 23006-19B
Gossamer Bio is searching for a creative, resourceful, and collaborative scientist to join our CMC process chemistry team with the primary responsibility of successfully conducting laboratory process chemistry efforts to enable manufacture of non-GMP & GMP drug substance on multi-kilogram scale in a safe and efficient manner. These responsibilities include investigation/execution of complex molecule synthesis, route scouting, and development of robust chemical processes to support internal efforts and assist with technology transfer to CDMOs. Additionally, s/he will implement laboratory processes/strategies to support medicinal chemistry scale-up and pre-formulation activities, as well as enable acceleration of preclinical candidates towards development. The candidate will also serve as a resource of scientific and technical expertise with opportunities to assume departmental responsibilities for assigned projects and equipment; and most importantly, will embrace our core values of putting people and patients first while thriving in a fast-paced, dynamic, and collaborative environment.
- Execute process R&D laboratory experiments for compounds under development and conduct route optimization to deliver non-GMP & GMP material on multi-kilogram scale.
- Proactively work with and support CMOs to manage external process development and manufacturing of intermediates and API.
- Conduct phase appropriate synthetic route design while focusing on implementation of control strategies for regulatory starting materials, intermediates and APIs.
- Support design and execution of fate and purge studies, synthesize analytical reference standards, and provide lab support to other CMC and medicinal chemistry functions.
- Work cross-functionally to communicate process chemistry timelines and objectives.
- Assist in review/approval of master batch records, validation protocols/reports and specifications required for drug substance manufacturing.
- Work with medicinal chemistry to ensure that synthetic route, final form and compound properties are appropriate for compounds preparing to enter development.
- Prepare technical reports and oral presentations; and contribute scientific expertise to programs supported by process chemistry.
Education and Experience
- Ph.D. with 3+ years experience or BS/MS with 7+ years of experience in organic chemistry, process research and development, chemical engineering, pharmaceutical sciences or closely related discipline with relevant small molecule development experience.
- Strong background in process chemistry techniques and practices.
- Excellent laboratory techniques, with an ability to think critically and problem solve.
- Experience working in and/or supporting a kilo-lab/pilot plant environment preferred.
- Extensive knowledge of laboratory instrumentation with an emphasis on use of scale-up equipment as well as HPLC, NMR, IR, GC, and MS spectroscopic techniques.
- Strong track record in developing innovative routes and processes for the synthesis of complex molecules.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Ability to manage multiple projects and rapidly adapt to changing program needs.
- Strong track record in process chemistry development, CMO management and multi-kilogram scale manufacturing.
- Ability to effectively organize and prioritize tasks to achieve deadlines.
- Excellent written and oral communication skills are required, as is the ability to excel in a collaborative multidisciplinary environment.
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 HR@GossamerBio.com.