Manager, CMC Project Management

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 for the first in late 2025.

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.

This role will report to the Director of CMC, Project Management.

About the role

The Manager, CMC Project Management will help support the development of FDA-approved longevity drugs expanding Loyal’s pipeline. This role will be responsible for leading CMC pipelines and overseeing the advancement from R&D to commercial stages by leveraging both internal resources and external collaborations.

You will be reporting to our Director, CMC Project Management.

Your daily work will include

• With support from CMC leadership, represent the CMC function on working Project Teams, aligning CMC activities and deliverables with development project strategies and goals.
• Collaborate with functional SMEs and CDMOs to plan and execute projects within agreed timelines, ensuring timely communication and alignment.
• Ensure timely, proactive project updates that identify risks, status, opportunities, and mitigation/acceleration strategies. 
• Develop and maintain CMC project plans, incorporating activities, internal/external requirements, and key interdependencies to deliver tangible results against program and corporate goals.
• Direct and coordinate multiple projects to ensure on-time and on-budget delivery.
• With support from CMC leadership, lead the CMC cross-functional teams to identify, define, prioritize, and mitigate risks to successful project execution; monitor progress and implement risk mitigation contingency plans.
• Escalate project issues that can delay timeline, impact scope, or increase cost to project governance committees, the Loyal project team, and/or the Loyal e-team as appropriate. Develop solutions with the project team and propose mitigation strategies. 
• Maintain financial accountability for assigned projects ensuring budgets are established, followed, and change controls managed appropriately. Proactively manage and communicate unplanned deviations to budget owners. 
• With support from CMC leadership, manage external suppliers, including contract manufacturing and development organizations (CDMOs), to ensure timely and high-quality delivery of CMC-related activities.
• Create presentations, dashboards, and reports to communicate project status, key internal metrics, and/or risk mitigations. Proactively share with Project teams and stakeholders.
• Maintain operational CMC project timelines, troubleshooting delays creatively with SMEs.

About you

• Bachelor's degree required with a specialization in science, engineering, or health related field; advanced degree is a plus but not required. PMP, or other project management certification preferred but not required.
• 5+ years of experience in the pharmaceutical (animal health or human therapeutics) industry, with a proven track record of leading CMC pipelines.
• Knowledgeable in CMC development & commercialization – ideally for both small molecule and complex peptide products with a focus on solid dose development
• Solid understanding of PMP best practices and strong organizational skills to manage a complex CMC development pipeline.
• Enjoy thinking creatively, anticipating challenges, and developing innovative solutions to complex problems.
• Commitment to excellence, integrity, and ethical conduct in all aspects of R&D and commercialization.
• Effective and efficient verbal and written communication with working team through executive/ board level
• Experience in google suite is preferred although not required.

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 🐶
• Annual company retreat at beautiful locations across the country (recently: Tahoe, Cape Cod)
• Competitive salary
• Company equity options grant for new hires

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. 

Our values

Lean into moonshots

We don’t 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 leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams 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.