Associate Director / Director, Analytical Development

Job Description

Job Description

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 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 and highly motivated Associate Director / Director of Analytical Development to manage and drive analytical development and quality control activities across our small molecule drug discovery and development programs. Reporting to the Vice President, CMC, this individual will fill a critical role as the subject matter expert (SME) and functional lead and will contribute to the strategic direction, technical management, and operational execution for CMC development and manufacturing activities. This position is instrumental in collaborating with and managing a network of consultants and Contract Development and Manufacturing Organization (CDMOs) partners to enable our efforts to discover and develop small molecule therapeutics.

Responsibilities

• Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry, form and formulation development, and GMP manufacture.
• Contribute to the CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product in alignment with industry standards and regulatory expectations.
• Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability of drug substance and drug product.
• Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventative actions, deviations, and investigation, including OOS and OOT events.
• Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents, and remain current on Health Authority guidance and expectations.
• Contribute to the development of CMC strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals.
• Support development of the quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
• Establish and manage a reference standard program, including oversight of qualification and maintenance of reference standards at CDMOs.
• Support the evaluation, selection, and management of CDMOs to perform process and method development, and GMP manufacture, release testing, and stability studies.
• Represent CMC and participate in cross functional project teams and manage multiple priorities in a fast-paced, dynamic environment and enact quick problem solving to ensure on-time supply of drug to support non-GLP toxicology studies, IND-enabling activities, and clinical trials across a portfolio of programs.

Qualifications

The anticipated salary range for candidates who will work in South San Francisco, CA is $185,000 - $240,000. 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.