Principal Scientist, Formulation

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

We’re seeking an experienced Senior to Principal Scientist, Formulation, to lead the formulation and process development of new drug products at Loyal. This includes pre-formulation, scale-up, optimization, registration, pivotal clinical, and PPQ manufacturing activities. 

Your work will have a significant impact on developing robust, effective, and safe drug products that the business will bring to the market.

This role is for someone who has extensive experience with novel drug formulation and process development and CDMO management. The ideal candidate should be an expert in developing oral solid dosage forms and be adept at working collaboratively with both internal and external partners. 

You will be reporting to our Principal Scientist – CMC Manufacturing.

Your daily work will include:

• Leading the planning and execution of pre-formulation, feasibility formulation, and production of pre-clinical/clinical trial materials.
• Developing formulations through managing, visiting, and building relationships with Contract Development and Manufacturing Organizations (CDMOs).
• Providing strategic and tactical input to the overall product development plans including: raw material sourcing, formulation development, quality, and manufacturing activities.
• Proactively identifying issues, risks, and opportunities to improve and optimize product development and manufacturing processes. 
• Authoring and reviewing CMC sections for regulatory filings and interacting with regulatory agencies to answer questions.
• Executing technical due diligence and review of CDMO proposals, protocols, data, master batch records, and reports.
• Designing studies, analyzing data, identifying risks, and developing solutions to experimental challenges.
• Attending internal project meetings and leading activities with external partners.
• Communicating effectively to drive decisions. 
• Act as a senior formulator that networks externally for identifying appropriate technical consultants and mentors other internally to grow the company’s capabilities. 

About you: 

• You have a Bachelor’s or Advanced degree (master’s or Ph.D.) in Chemistry, Chemical Engineering, or related physical science.
• A minimum of 8 years of experience in oral solid dosage formulation development and demonstrated a successful track record of executing drug product development.
• Must have worked with novel drug products.
• Significant experience in managing CDMOs or equivalent.
• Industry expertise in key CMC areas, including small molecule oral tablet formulation development, technical transfers, scale-up and manufacturing activities.
• Direct experience or working knowledge of compaction simulation equipment, software, and fundamentals.
• Significant experience using design of experiments early in development.
• New molecular entity and veterinary dosage form development experience a plus.
• Willing to work and comfortable in a fast-paced startup environment with a dynamic team.

Loyal benefits:

• Full-coverage health insurance — medical, dental and vision — for you and your dependents
• $1,000 home office equipment stipend
• $1,200/year learning budget for books, courses, etc.
• $250/month wellness budget for gym, cleaners, spa, food, etc.
• All 3-day weekends are turned into 4-day weekends 🎉
• Unlimited vacation and paid holidays
• Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
• Competitive salary
• Company equity options grant for new hires

Salary Range: $125,000 - $200,000

Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. 

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