Staff Scientist, Pharmaceutical Development

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs, many in the Endocrinology space, with potential for growth to target many GPCRs that have been undruggable and unexploited to date.

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team.

We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.

For more information see: www.septerna.com.

THE ROLE

We are seeking an experienced Staff Scientist with expertise in formulation development to support our small molecule pipeline. They will ensure that fit for purpose formulations are used for nonclinical in vivo studies. They will design, execute, manage, and analyze studies to develop and deliver formulations that support nonclinical DMPK, pharmacology, and toxicology studies. They may also support the development of clinical formulations.

This position reports to the Director of Pharmaceutical Development is an onsite position requiring in-person collaboration with cross-functional teams.

Responsibilities

• Develop early formulation strategies and serve as an SME to deliver fit-for-purpose formulations supporting PK, PD, efficacy, and safety preclinical studies through discovery to candidate selection across research programs.
• Design, manage, and execute early formulation screening studies to enable high-quality in vivo data, including solubility assessments, excipient compatibility, enabling approaches, and stability.
• Implement early formulation development and preparation workflows, tools, templates, and best practices internally and in partnership with CDMOs/CROs to support preclinical studies.
• Represent early formulation on cross-functional research teams, presenting data and recommendations to ensure aligned and timely support.
• Author and review technical documents to support early formulation activities and preclinical studies, including development reports and study protocols.
• Manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of formulations to support preclinical studies across programs.

Qualifications

• A PhD, MS, or BS in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field with a minimum of 6 years, 10 years, or 12 years, respectively, of relevant industry experience in small molecule formulation development.
• Demonstrated success delivering formulation strategies to support preclinical research studies using data-driven, risk-based strategies.
• Experience in small molecule formulation development across multiple routes of administration, including powders, solid dosage forms, solutions, suspensions, nanoparticles, and lipid-based systems.
• Hands-on experience with analytical techniques to support small molecule formulation development, including UPLC/HPLC and solid-state characterization techniques (e.g., particle size analysis, DSC, DVS, PLM, and XRPD).
• Working knowledge and practical application of current industry and compendial standards and regulatory authority guidance and expectations, including ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia.
• Ability to manage and collaborate with external partners, including consultants and CDMOs/CROs.
• Excellent interpersonal and communication skills (written and oral) with the ability to effectively prepare high-quality technical documentation and concisely present data to peers, management, and external groups.
• Exhibited strong organizational and critical thinking skills with an attention to detail and data integrity enabling sound, technically driven decision making.
• Able to travel domestically and internationally as needed, up to 20% of the time.

The anticipated salary range for candidates who will work in South San Francisco, CA is $160,000 - $180,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.  We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.  Septerna participates in the E-Verify program.  California Consumer Privacy Act Privacy Notice For Job Applicants.  If you are a California resident, click here for our CCPA Notice.