Principal Scientist - Formulation
Loyal
Remote
Posted on Wednesday, July 26, 2023
Loyal is developing drugs to extend dog lifespan; we aim to build the defining aging company. Founded in early 2020, we have raised over $50M from Khosla Ventures, First Round Capital, Collaborative Fund, Longevity Fund, Quiet Capital, BoxGroup, and more. Loyal is working on bringing to market the first drugs intended to extend lifespan (years of life) and healthspan (quality of life). We aspire to build a pharma brand people love around deeply technical products. While we are currently focusing on dog drugs, our ultimate aim is to take what we learn in dogs to leapfrog into human aging drugs and build a company that catalyzes and captures the public’s excitement around aging therapeutics
Loyal is ~18 months away from our projected launch of our first product to market. We are seeking an experienced Formulation Principal Scientist to lead the planning and execution of drug product development, from pre-formulation through Registration, Pivotal Clinical, and PPQ Manufacturing activities.
Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants.
You Will
- Lead the planning and execution of drug product development from pre-formulation, formulation development and characterization, production of pre-clinical and clinical trial materials.
- Develop formulations through managing, visiting, and building relationships with competent Contract Development and Manufacturing Organizations (CDMOs).
- Provide strategic and tactical input to the overall product development plans including raw material sourcing, formulation development, quality, and manufacturing aspects.
- Proactively identify issues, risks, and opportunities to improve and optimize product development and manufacturing processes.
- Author/review CMC sections for regulatory filings and, if requested, interact with regulatory agencies to answer questions.
- Complete technical due diligence of CDMO proposals, protocols, data and reports.
- Design studies, propose decisions, and identify risks to the projects.
- Attend internal project meetings and lead activities with external partners.
- Communicate effectively to drive decisions.
- Negotiate supply and service agreements.
How you work and think
- Startup mindset: work fast/be decisive, low ego, comfortable with uncertainty, and collaborative
- Enthusiastic participant in a team-oriented culture: the success of all leads to the success of the company
- Concise, logical thinker who can communicate complicated topics with ease
- Detail oriented, disciplined, naturally seek ownership and responsibility, and happy working on a mix of the fascinating and the mundane
- Able to lead Intradepartmental and cross-functional collaboration meetings and give technical presentations
- Able to quickly learn new concepts and processes
- Adaptable, creative and high-performing in risk-assessment and strategic thinking
- Detailed eye for logistics and problem solving
- Clear and polite communication skills
- Need minimal supervision and can adapt to the dynamic of a startup environment
- Comfortable managing others- laterally, up, and potentially direct reports
- Familiarity with G suite applications (e.g., Sheets, Slides, etc.)
- Highest standards for scientific quality and rigor
- Clear communicator of scientific topics and challenges
- Love to learn and excited to self-teach random topics as relevant to the company and projects
- Able to meet or beat rapid deadlines and work well under pressure
- Growth mindset, value transparency, seek out feedback and iteration cycles
About You
- You have a Ph.D. or equivalent experience in Chemistry, Chemical Engineering, or related physical science
- 8+ years of experience in oral solid formulations in a similar role and demonstrated successful track record of executing drug product development
- Must have worked on pioneer products (can be existing molecule or new molecule, but not a generic product)
- You have significant experience managing CDMOs or equivalent
- You have industry expertise in key CMC areas, including small molecule oral tablet formulation development, technical transfers, scale up and manufacturing.
- Experience using design of experiments early in development
- New molecular entity experience a plus
Logistics and Benefits
- Full-time position either remote or based in San Francisco, CA with flexible hybrid work opportunities
- Full coverage health insurance (medical, dental and vision) for you and your dependents.
- $1000 home office stipend
- $150/month wellness budget (cleaners, spa, food)
- $75/month fitness budget
- $100/month learning budget (books, courses, etc.)
- All 3 day weekends turned into 4-day holidays
- Unlimited vacation
Our Values
Lean into moonshots | We do not settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
Opportunity is at the intersection | We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Expertise without ego | Titles do not determine who has a voice. We work on hard, technical problems and have a ton of fun while at it.
Learning by doing | Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
Lead with context | We value transparency and equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. Empower the team to succeed.
Empathy and respect for all life | Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.