Associate Director of Process Chemistry
About the job
- A PhD, MS, or BS degree in organic chemistry or a related field, with at least 7, 10, or 12 years, respectively, of relevant industry experience in small molecule drug substance development and increasing responsibilities within process chemistry.
- A track record of successfully delivering drug substance activities from non-GLP and IND-enabling material supplies through GMP clinical trial supplies and commercialization.
- Expertise in small molecule synthetic route evaluation, process development, scale-up, manufacturing, and phase-appropriate control strategy and specification development.
- Experience with analytical techniques supporting small molecule process development, including proficiency in UPLC/HPLC, GC, MS, NMR, and solid-state characterization techniques such as particle size distribution and XRPD.
- Strong understanding of Quality systems, including SOPs, manufacturing record review, batch release and disposition, Good Documentation Practices, cGMP data traceability, deviations, and change management.
- Knowledge and 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.
- Ability to prepare high-quality technical documentation and present data to peers, management, and external groups.
- Ability to travel domestically and internationally as needed, up to 20% of the time.
- Act as a Process Chemistry subject matter expert supporting drug substance development, including process chemistry, solid form selection, crystallization development, and GMP manufacture.
- Lead process development efforts, including route scouting, process optimization, and scale-up, and implement mitigation strategies to ensure robust, cost-effective, safe, scalable, and phase-appropriate manufacturing processes.
- Contribute to CMC control strategies defining starting materials, impurity control strategies, and specifications for starting materials, intermediates, and drug substance in alignment with industry standards and regulatory expectations.
- Support the evaluation, selection, technology transfer, and management of CDMOs for route and process development and GMP manufacture.
- Contribute to CMC strategies that meet program and project development targets, ensure timely delivery of high-quality products, and facilitate regulatory approvals.
- Collaborate within CMC with Analytical Chemistry and Formulation Development, and across Quality, Medicinal Chemistry, DMPK, Toxicology, Project Management, Development Sciences, and Clinical Pharmacology to achieve project goals.
- Manage multiple priorities and solve problems to ensure on-time drug supply for non-GLP toxicology studies, IND-enabling activities, and clinical trials across multiple programs.
- Support development of the Quality system to ensure product quality and data integrity, including authoring and reviewing standard operating procedures, guidelines, and work instructions.
- Author and review process development reports, batch records, campaign reports, change controls, corrective and preventative actions, deviations, and investigations.
- Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and supporting technical documents, and remain current on Health Authority guidance and expectations.
About the company
Septerna develops and licenses a platform called Native Complex™ that enables drug discovery on G protein-coupled receptors (GPCRs) outside of cells. The platform reproduces GPCRs with their original structure, function, and dynamics, allowing scientists to design drugs based on GPCR structures and to perform ultra-large-scale screening across the full GPCR target class. This helps unlock GPCR targets that were previously hard to study and could lead to new medicines. The company differentiates itself by offering an industrial-scale, structure-based discovery workflow specifically for GPCRs, paired with a licensing business model for pharmaceutical companies. Its goal is to expand therapeutic options by turning more GPCRs—previously considered undruggable—into viable drug targets and to bring GPCR-targeted medicines to market through licensing and partnerships.
Company Size
51-200
Company Stage
IPO
Headquarters
South San Francisco, California
Founded
2022
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Simplify's Take
What believers are saying
- September 2026 CMO Rajiv Patni strengthens clinical execution for upcoming readouts.
- SEP-479 Phase 1 started in April 2026; data arrives late 2026 or early 2027.
- SEP-631 showed positive Phase 1 data, with a Phase 2b urticaria study planned.
What critics are saying
- SEP-479 and SEP-631 remain early; Phase 1 failures erase the thesis quickly.
- Novo Nordisk collaboration drives revenue; any program termination slashes Septerna’s 2026 funding.
- If GPCR oral candidates underperform, Septerna becomes a platform story without product revenue.
What makes Septerna unique
- Septerna’s Native Complex platform tackles historically inaccessible GPCRs with oral small molecules.
- It combines structure-based design and industrial screening across the entire GPCR target class.
- Novo Nordisk partnered in 2025, validating Septerna’s platform beyond internal discovery.
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2%Septerna, Inc. (SEPN) stock analysis: unveiling a 42% potential upside amidst biotech innovation. Investors are increasingly turning their attention to Septerna, Inc. (NASDAQ: SEPN), a burgeoning player in the biotechnology sector, driven by its promising potential upside and cutting-edge developments in the field of G protein-coupled receptor (GPCR) therapies. As a clinical-stage company, Septerna is making strides with an innovative pipeline targeting a range of diseases, from endocrinology to metabolic disorders, all while capturing the interest of Wall Street analysts. Septerna's current market valuation stands at $1.78 billion, a reflection of investor confidence in its capabilities and strategic direction. The company's focus on GPCR oral small molecule products positions it uniquely within the biotechnology industry, especially given its collaborations with pharmaceutical giants like Novo Nordisk. This partnership aims to leverage Septerna's technological prowess to develop oral therapies for metabolic diseases, reinforcing the company's potential to revolutionize treatment paradigms. The stock's current price of $38.13 places it within a 52-week range of $16.75 to $48.19, indicating a solid recovery and growth trajectory from its lower bounds. Notably, analysts have set a target price range of $48.00 to $62.00, with an average estimate of $54.22, suggesting a remarkable potential upside of 42.20%. Such optimism is underpinned by 10 buy ratings, with no hold or sell recommendations, underscoring widespread confidence in Septerna's growth prospects. Despite the absence of earnings, as indicated by its negative EPS of -0.53 and a forward P/E of -19.64, Septerna exhibits impressive financial metrics that cannot be overlooked. The company's revenue growth rate of 22,375.60% is a testament to its robust expansion capabilities, while a free cash flow of $29.5 million further highlights its financial agility and capacity to fund ongoing research and development efforts. Technically, Septerna's stock is navigating within intriguing parameters. The 50-day moving average of $38.29 closely aligns with its current price, suggesting a period of stabilization, while the 200-day moving average of $30.43 indicates a longer-term upward trend. The RSI (14) at 89.64 suggests that the stock may be overbought, signaling potential caution for momentum traders. However, the MACD of -0.15, slightly above the signal line of -0.10, could be hinting at a possible bullish crossover on the horizon. Septerna is not just a story of present-day metrics; it is a narrative of future potential. While it does not yet distribute dividends, the company's focus on reinvestment into its high-potential pipeline projects is a strategic allocation aimed at maximizing long-term shareholder value. The lack of a P/E ratio and Price/Book metrics reflects its current phase in the biotech lifecycle, where growth and innovation are prioritized over immediate profitability. Septerna's strategic initiatives, including its PTH1R Program for hypoparathyroidism and SEP-631 for chronic spontaneous urticaria, are complemented by its exploration into neurology, cardiovascular, and respiratory diseases. These endeavors underscore Septerna's commitment to addressing diverse therapeutic areas, broadening its market reach, and enhancing its value proposition. For investors looking at the biotech sector, Septerna represents a compelling opportunity. Its strategic alliances, ambitious pipeline, and impressive revenue growth foster a fertile ground for potential gains. However, as with all clinical-stage biotech investments, it is crucial to weigh the inherent risks associated with drug development and regulatory hurdles. With a clear vision and robust market interest, Septerna, Inc. stands poised to make significant contributions to the healthcare landscape and deliver substantial returns to its investors. * Written by: Madison Wilson
Septerna has granted stock options to purchase up to 275,000 shares to Rajiv Patni, its newly appointed Chief Medical Officer. The options, effective 8 September 2026, were issued under the company's 2026 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $37.37 per share, matching the closing price on the grant date. They carry a ten-year term and vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months, contingent on continued employment. Septerna is a clinical-stage biotechnology company focused on GPCR therapies. The company uses its Native Complex Platform to develop oral small molecule drug candidates across endocrinology, immunology, inflammation and metabolic diseases.
Septerna, a clinical-stage biotechnology company focused on G protein-coupled receptor drug discovery, has appointed Rajiv Patni as chief medical officer. Dr Patni brings over 25 years of experience in biopharmaceutical research, development, and regulatory affairs. Dr Patni previously served as chief executive officer at Judo Bio and held senior positions at several companies including Reata Pharmaceuticals, Global Blood Therapeutics, and Portola Pharmaceuticals. He has contributed to programmes resulting in 10 regulatory approvals or label expansions across the US, Europe, and other markets. The appointment comes as Septerna advances its pipeline targeting endocrinology, immunology, and other therapeutic areas. The company's proprietary Native Complex Platform is designed to enable new approaches to developing oral small molecule drug candidates.
Septerna appoints industry veteran Rajiv Patni, M.D., as Chief Medical Officer. August 25, 2026 08:00 ET | Source: Septerna, Inc. SOUTH SAN FRANCISCO, Calif., Aug. 25, 2026 (GLOBE NEWSWIRE) - Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the appointment of Rajiv Patni, M.D., as Chief Medical Officer. Dr. Patni is a physician-scientist and accomplished biopharmaceutical executive with more than 25 years of experience leading research, development, regulatory, and medical affairs organizations. "We are thrilled to welcome Rajiv to the team as we execute on our strategy to develop differentiated oral medicines targeting GPCRs," said Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna. "Rajiv brings deep clinical development experience across multiple therapeutic areas and a successful track record of guiding investigational medicines from early clinical studies through regulatory agency approvals. His leadership will be instrumental as we advance our clinical programs and continue to build a world-class development organization to deliver new medicines for patients in need." "Throughout my career I have joined companies at inflection points in their R&D trajectory, and that is where Septerna is today," said Dr. Patni. "Our pipeline targets significant unmet needs spanning endocrinology, immunology, and other therapeutic areas. I look forward to helping translate Septerna's unique expertise in GPCR drug discovery into clinical evidence and ultimately into important new medicines for patients who need better oral treatment options." Dr. Patni joins Septerna from Judo Bio where he most recently served as Chief Executive Officer. Previously, he was Chief Research and Development Officer at Reata Pharmaceuticals. Earlier, Dr. Patni served as Chief Medical Officer at Global Blood Therapeutics, Portola Pharmaceuticals, Adamas Pharmaceuticals and Actelion Pharmaceuticals, companies that, together with Reata, were subsequently acquired. Earlier in his career, Dr. Patni led development teams at Pfizer and Roche Pharmaceuticals. Over the course of his career, Dr. Patni has contributed to programs that resulted in 10 regulatory agency approvals or label expansions in the United States, Europe and additional markets. He currently serves as a director of BioXcel Therapeutics. Dr. Patni holds an M.D. from the Icahn School of Medicine at Mt. Sinai and completed his internal medicine residency and cardiology fellowship at the Albert Einstein College of Medicine. About Septerna Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company's proprietary Native Complex Platform(R) is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com.
Septerna (NASDAQ: SEPN) grows Q1 revenue to $26.5M, trims loss. Filing Impact (Moderate) Filing Sentiment Rhea-AI Filing summary. Septerna reported strong top-line growth for the three months ended March 31, 2026, with revenue of $26.5 million driven by its Novo Nordisk collaboration, compared with $0.2 million a year earlier. Revenue included recognition of upfront, research and milestone consideration under the agreement. Research and development expense rose to $29.5 million and general and administrative expense to $10.3 million, reflecting pipeline expansion and public-company costs. Net loss narrowed to $8.6 million from $21.5 million, helped by collaboration revenue and $5.0 million of interest income. Septerna ended the quarter with $522.1 million in cash, cash equivalents and marketable securities and deferred revenue of $152.0 million, and expects this liquidity to fund operations at least into 2029. The company also initiated a Phase 1 trial of SEP-479, an oral PTH1R agonist for hypoparathyroidism, with data anticipated in late 2026 or early 2027. Key figures. Revenue: $26,523 thousand Net loss: $8,637 thousand R&D expense: $29,535 thousand +5 more Key terms. Native Complex Platform(R), G protein-coupled receptor, at-the-market offering, deferred revenue, +2 more Earnings snapshot. Revenue: $26,523 thousand 05/11/2026 - 01:08 PM Faq. How much revenue did Septerna (SEPN) report for Q1 2026? Septerna reported Q1 2026 revenue of $26.5 million, up from $0.2 million in Q1 2025. This increase primarily reflects recognition of upfront, research and milestone consideration from its Novo Nordisk collaboration under long-term licensing and research agreements. What was Septerna's net loss for the three months ended March 31, 2026? Septerna recorded a Q1 2026 net loss of $8.6 million, narrowing from $21.5 million a year earlier. Higher collaboration revenue and $5.0 million of interest income offset increased research and development and general and administrative expenses tied to pipeline growth. What is Septerna's cash and investment position as of March 31, 2026? As of March 31, 2026, Septerna held $522.1 million in cash, cash equivalents and marketable securities. Management believes this balance will fund planned operating and capital needs at least into 2029, supporting ongoing research, clinical development and public-company obligations. How significant is Septerna's Novo Nordisk collaboration to its Q1 2026 results? The Novo Nordisk collaboration was central to Q1 2026 results, contributing $26.5 million of revenue. This included recognition of a portion of the $195.0 million upfront payment, research services and milestones, with $219.1 million of transaction price still unrecognized for future periods. What clinical progress did Septerna (SEPN) report for SEP-479? Septerna announced first dosing in a Phase 1 trial of SEP-479, its oral PTH1R agonist for hypoparathyroidism. The randomized single- and multiple-ascending dose study in up to 150 healthy adults assesses safety, tolerability, pharmacokinetics and pharmacodynamics, with initial data expected late 2026 or early 2027. How are Septerna's research and development expenses trending? Research and development expenses rose to $29.5 million in Q1 2026 from $19.3 million in Q1 2025. The increase reflects higher employee-related costs, external program spending across the pipeline, and platform investments as the company advances multiple GPCR-targeted oral small molecule programs.