Full-Time

Senior Principal Scientist Drug Substance

Drug Substance

Updated on 9/3/2026

Loyal

Loyal

201-500 employees

Develops aging therapies for canine health.

Compensation Overview

$175k - $230k/yr

Remote in USA

Remote

PhD

Category
Biology & Biotech (1)

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Requirements
  • Ph.D. in Chemistry, Chemical Engineering, Biochemistry, or a related discipline.
  • 12+ years of industry experience in drug substance process development and manufacturing, with demonstrated ownership from early development through regulatory submission and commercialization phase.
  • Hands-on expertise in small molecule API process development, including synthetic process understanding, impurity profiling, ICH Q11 RSM assessment, and ICH M7 mutagenic impurity control.
  • Proven experience selecting, managing, and technically overseeing CDMOs for small molecule drug substance development, scale-up, technology transfer and PPQ.
  • Demonstrated experience authoring and defending drug substance CMC regulatory submissions (INAD/NADA, VMF or equivalent) and interacting with regulatory agencies on CMC questions.
  • Deep knowledge of applicable regulatory frameworks: ICH Q7, Q8, Q9, Q10, Q11, Q6A, M7, and relevant VICH guidelines for veterinary drug substances.
  • Demonstrated ability to operate effectively in a dynamic, fast-paced startup environment with a high degree of autonomy and accountability.
  • Experience with large biomolecule drug substance development (peptides, proteins, or other biological entities) preferred but not required.
  • Veterinary dosage form experience preferred but not required.
Responsibilities
  • Lead end-to-end drug substance process development and manufacturing for small molecule APIs from synthetic route assessment and impurity control through scale-up, technology transfer, and commercial manufacturing readiness at CDMOs.
  • Serve as the primary technical interface with drug substance CDMOs spanning partner selection, day-to-day oversight, troubleshooting, PAI preparation and performance management; ensure drug substance supply continuity, including second source qualification and starting material supply risk strategy, in support of clinical and commercial manufacturing.
  • Lead RSM designation, ICH Q11 assessments, impurity fate and purge strategies and ICH M7 mutagenic impurity risk assessments; establish CQAs, CPPs, and ICH Q6A-aligned control strategies.
  • Lead drug substance process validation from PPQ protocol development through batch execution and CPP/CQA verification; align PPQ timelines and batch disposition with drug product process validation and registration batch campaigns.
  • Author, review, and approve drug substance CMC sections for regulatory submissions (VMF, INAD/NADA); represent drug substance CMC in agency interactions and ensure a technically integrated and consistent regulatory package.
  • Partner with drug product development to translate drug substance CQAs into formulation design, excipient selection, container closure strategy and final dosage form decisions.
  • Partner with analytical development to define method development, qualification, and validation strategy for drug substance release and stability testing.
  • Partner with Quality to align drug substance specifications, batch disposition, and GMP compliance across CDMOs, and to support inspection and regulatory submission readiness.
  • Manage drug substance post-approval change control strategy for manufacturing changes at CDMOs.
Desired Qualifications
  • Experience with large biomolecule drug substance development (peptides, proteins, or other biological entities) preferred but not required.
  • Veterinary dosage form experience preferred but not required

Loyal focuses on extending dogs’ healthspan and lifespan by developing therapies that target the aging process in canines. Its work rests on veterinary geroscience research and technologies drawn from genetics, behavior genomics, and canine health studies. The company develops and commercializes therapeutic products designed to address underlying aging mechanisms, with revenue from product sales and potential licensing of its technologies to other veterinary and biotech partners. Loyal differentiates itself through deep scientific research into canine aging, substantial funding, and a patient-centric approach that emphasizes the quality of life for aging dogs, as well as community engagement through early access to studies and updates. The company’s goal is to improve the longevity and overall well-being of dogs by advancing therapies that slow aging and enhance healthspan for aging canine companions.

Company Size

201-500

Company Stage

Series C

Total Funding

$238M

Headquarters

San Francisco, California

Founded

2019

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Simplify Jobs

Simplify's Take

What believers are saying

  • Loyal raised $100 million on February 11, 2026, led by age1 and Baillie Gifford.
  • The company says LOY-002 cleared RXE and TAS, leaving one approval section.
  • Loyal plans to submit the final XCA requirement in 2026 for market launch.

What critics are saying

  • FDA approval remains unfinished; Loyal still needs the final XCA section.
  • Any STAY shortfall can delay launch, because 1,300-dog efficacy data anchors approval.
  • A failed 2026 FDA path leaves Loyal without revenue and likely forces shutdown.

What makes Loyal unique

  • Loyal's LOY-002 targets aging pathways, not single diseases, in senior dogs.
  • FDA accepted LOY-002's TAS section on January 13, 2026.
  • STAY enrolled 1,300 dogs across 70-plus veterinary clinics, unusually large for animal health.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Home Office Stipend

Professional Development Budget

Wellness Program

Unlimited Paid Time Off

Paid Holidays

Stock Options

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

2%

2 year growth

2%
Business Insider
Aug 29th, 2026
Bryan Johnson tackled human longevity. Now he wants dogs to live forever.

Bryan Johnson tackled human longevity. Now he wants dogs to live forever. Aug 29, 2026, 3:00 AM PT Tech entrepreneur Bryan Johnson has become famous for his mission to help humans live forever, with his catchphrase "Don't die." Now he wants to do the same thing for dogs. Johnson's interest in canine longevity was piqued when he recently adopted a professionally trained Belgian Malinois named Katara to protect him from attackers. This week, at a longevity event in San Francisco, Katara was a constant presence at Johnson's side as he cheered on tech workers trying to complete as many push-ups as possible, one metric used to measure their biological age. Later, Katara, who will turn two in October, lay patiently at Johnson's feet as he was interviewed by venture capitalist Sarah Guo. "I get quite a few death threats, and so she is my guard dog," Johnson explained to Guo. "We go everywhere together, and we have bonded for the past month." Johnson clarified to Business Insider that he has no plans to launch a company focused on canine health yet. Rather, Katara will be subjected to a version of the rigorous data collection and longevity interventions that he chronicles in great detail for his millions of followers on X and Instagram. "She's going to become the most measured dog in the world," he said in an interview. "We're going to do a whole bunch of longevity therapies on her because dogs are amazing." Johnson thinks there may be relatively straightforward ways to improve dogs' health, starting with food. He said most commercial dog food contains much higher concentrations of harmful compounds. "These are things that glue your organs together," he said. "We're feeding them things that are terrible for their bodies." Dogs and humans are not as different as one might expect, according to Johnson. That means advances in dogs can also help humans. "It's remarkable how much dogs and humans have in common," he said. "When you read through the literature on dogs, and you just replace humans with dogs, there are so many similarities." Johnson has often been frustrated by how long it takes for new human treatments to be approved. That is much less of a problem in animals. "The path for drug approval is substantially faster for dogs than humans, so you can get a lot of scientific work done in a shorter period of time," he said. Several startups are already working to extend dogs' lifespans. Loyal is developing the first FDA-approved longevity and lifespan-extension drugs for dogs, while Rejuvenate Bio is taking a more experimental gene-therapy approach, targeting chronic age-related diseases in animals, such as osteoarthritis, heart disease, and cancer. Johnson does not expect convincing people to improve their dogs' health to be difficult. As someone who urges people to sleep more and avoid alcohol, he has found that many will prioritize their pets' well-being over their own. "Humans will oftentimes care for their dogs better than they'll care for themselves," he said.

Pulse
May 5th, 2026
Loyal raises $100 million: dog longevity drugs targeting IGF-1 and PPAR pathways.

Loyal raises $100 million: dog longevity drugs targeting IGF-1 and PPAR pathways. - May 5, 2026 Why it matters. Extending dogs' healthy lifespans creates a multi-billion-dollar opportunity in pet care and provides a large-scale model that could accelerate human anti-aging drug development. Key takeaways. * - Loyal secured $100M Series A to advance canine longevity drug. * - Drug targets IGF-1 and PPAR pathways linked to aging. * - FDA deemed pill likely effective, moving toward market approval. * - Extending dog lifespan could reshape pet care industry revenues. * - Success may accelerate human anti-aging research using similar pathways. Pulse analysis. Loyal's recent $100 million Series A round, led by venture firms focused on longevity, gives the startup the capital to push its canine anti-aging pill through late-stage trials. The compound works by modulating the insulin-like growth factor-1 (IGF-1) axis and activating peroxisome proliferator-activated receptors (PPAR), two pathways that have been repeatedly linked to cellular senescence and metabolic health in mammals. By fine-tuning these signals in dogs, Loyal aims to add roughly a year of healthy life, a claim that could open a multi-billion-dollar pet-health market. The U.S. Food and Drug Administration's recent "likely effective" determination moves the drug one step closer to approval, but Loyal must still satisfy safety, dosing, and post-marketing surveillance requirements. If cleared by late 2026, the pill could be sold through veterinary clinics and specialty pet pharmacies, tapping an estimated 90 million owned dogs in the United States alone. Analysts project that even a modest adoption rate - 5 percent of owners - could generate over $1 billion in annual revenue, reshaping how veterinarians counsel aging pets and their families. Beyond pets, Loyal's approach revives interest in translating IGF-1 and PPAR modulation to human therapeutics, a strategy already explored in rapamycin-based trials. Success in dogs would provide a large, genetically diverse pre-clinical model, potentially accelerating biotech investment in age-related drug pipelines. However, extending companion-animal lifespans raises ethical questions about resource allocation and the emotional impact of longer pet ownership. As investors pour capital into longevity science, Loyal's progress will be watched as a bellwether for the commercial viability of anti-aging medicines across species. Your next dog may live longer. A new pill could soon extend dogs' lives. How will that change its relationship with its pets? One day last november, my dog, Forrest, sat on the cold marble steps of the Smithsonian's natural-history museum in Washington, D.C., ready to meet Celine Halioua, a woman who may one day add a tail-wagging year or so to his life, and also the lives of millions of other dogs. In 2019, Halioua founded a company called Loyal, and in February 2025, a pill that she developed for dogs was deemed likely to be effective by the FDA. If the company ticks a few remaining boxes, the drug could soon be on sale, kick-starting a new era of longevity medicine that could eventually also lengthen humans' lives. More than 10,000 years ago, dogs made a farseeing bet on humans. They padded carefully up to its campfires, ate scraps, and kept watch, hitching their fates to a species that would soon bestride the planet. They have since become the fourth-most-populous large land mammal, trailing only sheep, cows, and goats, which all lead less pampered lives. Now PULSE is trying to keep its best animal friends around longer too. If only I could have explained all of this to Forrest before its walk with Halioua. As a Portuguese water dog, he hails from a clever breed, but he doesn't understand advanced pharmacology, so I worried that he might be indifferent to her, or even rude. But Halioua, who is 31, had arrived with a plan. She stooped down, squealed his name, and opened her hand, revealing a treat that he promptly devoured. Halioua was 18 years old when the cold fact of death blew through her. She was working at a neuro-oncology lab and couldn't unsee the cosmic unfairness of a brain-cancer diagnosis, the way it constricted the possibilities of a person's life and cut short their closest relationships. Death had an important role to play back when life was single-celled and simple, Halioua told me. It helped evolution iterate rapidly and build up more complicated organisms. But now that natural selection has created complex, intelligent animals - namely, PULSE - PULSE should stretch out the good, healthy part of its lifespan as well as that of its dogs, too. With extra decades, she said, PULSE might even become more forward-looking, and less likely to wreck a world that PULSE will have to keep living in. After college, Halioua enrolled in a doctoral program in genetics at Oxford and worked in life-extension research during her time off school. The field has never been uniformly rigorous in its approach to research. Over the years, Halioua has developed an aversion to what she described as longevity "bro science." She's not into the translucent-skinned gurus who primarily experiment on themselves and post their physiological data, including the duration of their sleeping erections, on X. She's not trying to gain eternal life through obsessively healthy living, she once told me over a tray of French fries.

Loyal
Feb 16th, 2026
Loyal’s Series C: $100M to advance the first longevity drug

Today we announced Loyal's $100M Series C. Hear from our Founder & CEO Celine Halioua on what this milestone means for Loyal and the advancement of the first longevity drug.

Longevity.Technology
Feb 11th, 2026
Loyal raises $100m as canine longevity drug nears approval

Loyal raises $100m as canine longevity drug nears approval. age1 leads Series C as Loyal advances LOY-002 toward FDA approval, completing key requirements for conditional approval. Loyal, the clinical-stage animal health company developing what it hopes will become the first FDA-approved drug for lifespan extension, has raised $100 million in a Series C financing led by age1, the next generation of Laura Deming's Longevity Fund. Baillie Gifford participated alongside existing investors. The raise follows a year in which the company completed two of the three major technical requirements for FDA Expanded Conditional Approval for its lead program, LOY-002, and finished enrollment of STAY, its pivotal efficacy trial involving more than 1,300 dogs across over 70 veterinary clinics nationwide. The capital is intended to carry Loyal from late-stage development into market readiness - a transition that, in drug development terms, is less about theory and more about documentation, manufacturing and distribution. LOY-002 is designed as a daily pill for senior dogs, intended to target metabolic pathways associated with aging in order to extend healthy lifespan. The company has previously reported that the FDA's Center for Veterinary Medicine has accepted both the Reasonable Expectation of Effectiveness and Target Animal Safety sections for LOY-002 as part of the Expanded Conditional Approval pathway. Longevity.Technology: Loyal's $100M Series C is easy to read as a capital vote, but it is really a regulatory vote - money arriving precisely because the unromantic mechanics of approval are now visible. By completing two of the three technical requirements for FDA Expanded Conditional Approval for LOY-002, and by fully enrolling its pivotal nationwide STAY study across more than 70 clinics, the company is doing something longevity biotechs are often accused of avoiding: operationalizing prevention at scale, in a real-world population, with endpoints regulators can interrogate. Dogs make this more than a feel-good detour; they are companion animals living in our exposures and our homes, and they offer a biologically plausible model of aging that moves fast enough to be tested within a commercial timeline. If age1's lead and Baillie Gifford's participation signal anything, it is that "longevity" becomes more investable the moment it starts to look like a product dossier rather than a philosophy. From concept to dossier. For Loyal's founder and CEO Celine Halioua, the financing marks both validation and obligation. "Our driving purpose at Loyal is to help dogs live longer, healthier lives," she said. "We're closer than ever to delivering a solution to the problem we set out to solve: an FDA-approved drug for canine lifespan extension. This capital will help our team see our lead program through the remaining FDA requirements and get to market [1]." The FDA's Expanded Conditional Approval pathway permits early approval of certain animal drugs based on a reasonable expectation of effectiveness, provided full demonstration of effectiveness is subsequently confirmed. Loyal has now secured acceptance of its safety and initial effectiveness data for LOY-002; what remains is the final demonstration of substantial evidence of effectiveness, supported by data from STAY, which the company describes as the largest clinical trial ever conducted in animal health [2]. Scale matters. Enrolling over 1,300 privately owned dogs in a longevity-focused trial introduces variability - breed, diet, environment, comorbidities - that laboratory models smooth away. It also brings the study closer to the conditions under which a commercial product would actually be used. Companion dogs age in our kitchens and backyards, not in controlled vivaria; their diseases are entangled with obesity, inactivity and environmental exposures that mirror our own. Investors and a preventive thesis. The investor mix reflects a maturing narrative around aging therapeutics. Alex Colville, Cofounder and General Partner of age1, framed Loyal's trajectory in explicitly cultural as well as scientific terms. "Loyal has created a scientific and cultural movement towards proactive therapeutics for aging," he said. "Very few realize the impact this has had to date and the impact it will have to come. The way we understand and approach aging will never be the same [1]." Such language would once have felt aspirational. Today, it sits alongside regulatory correspondence and trial enrollment figures. For Baillie Gifford, a firm known for long-horizon growth investing, the attraction lies in the combination of preventive medicine and commercial discipline. "Celine and the team are redefining how preventive care is approached in veterinary medicine," said Tom Slater, partner at Baillie Gifford. "Helping dogs live longer, healthier lives matters to many families. By combining scientific rigour with a clear regulatory plan, Loyal has the foundations to build a substantial business in a large and expanding market [1]." But behind the rhetoric is a simple economic observation: pet owners will routinely pay out of pocket for interventions that promise incremental gains in health or longevity. Add to this that veterinary medicine, which is less constrained by reimbursement codes than human healthcare, and you have an early proving ground for therapies that target aging biology, and do it directly rather, than treating its downstream complications one organ at a time. The canine model and its limits. Dogs occupy a particular place in translational research. They share our homes, our pollutants and often our waistlines; they develop age-related diseases that resemble human pathologies, from osteoarthritis to certain cancers. Their shorter lifespans compress timelines, allowing interventional studies to read out within years rather than decades. Yet they are not small humans, and regulatory success in veterinary medicine does not automatically confer efficacy in people. Even so, the conceptual step is notable. To seek approval for a drug intended to extend lifespan in a healthy aging population is to test the proposition that aging can be a legitimate therapeutic target, not merely an inevitability to be managed symptom by symptom. In that sense, LOY-002 functions as both product candidate and policy experiment. A proving ground for prevention. If LOY-002 achieves Expanded Conditional Approval and proceeds to market, the implications will extend beyond veterinary shelves. Longevity science has long wrestled with endpoints, biomarkers and evidentiary thresholds, but in this case, those debates are being translated into pill bottles and prescribing guidelines. Quietly radical and entirely practical. For now, Loyal's task is execution - completing the remaining FDA requirements, scaling manufacturing and preparing veterinarians for a new category of therapy. Should it succeed, the first routinely prescribed longevity drug may arrive not in a geriatric clinic, but in a vet's exam room.

FinSMEs
Feb 11th, 2026
Loyal Raises $100M in Series C Funding

Loyal raises $100M in Series C funding. February 11, 2026 Loyal, a San Francisco, CA-based clinical-stage animal health company, raised $100M in Series C funding. The round was led by age1 with participation from Baillie Gifford alongside existing investors. The raise brought the total amount to over $250M since its founding in late 2019. The company intends to use the funds to expand operations and its development efforts. Led by CEO and Founder Celine Halioua, Loyal is an animal health company developing LOY-002, a prescription daily pill, which is its lead program aiming to extend the healthy lifespan of senior dogs by proactively targeting the underlying metabolic drivers of aging. With the Reasonable Expectation of Effectiveness (RXE) and Target Animal Safety (TAS) sections complete, the company has satisfied two of the three major requirements for LOY-002's application for Expanded Conditional Approval (XCA). It currently has three drugs in development and is making progress toward approval from the FDA's Center for Veterinary Medicine. 11/02/2026