People Matter

CMC Project Manager



United States · Remote
Posted on Tuesday, May 14, 2024

About Loyal

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

We’ve already achieved significant milestones on our path to gaining FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track to bring the first product to market in 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.

About the role

We’re seeking an experienced CMC Project Manager to help bring the first FDA approved longevity drug to market and further expand Loyal’s pipeline.

You will be responsible for leading CMC pipelines, and will oversee the advancement from R&D and commercial by leveraging both internal resources and external collaborations.

This role requires leadership, strong interpersonal and communication skills, and deep appreciation of CMC-related critical path activities.

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.
  • 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.

Your daily work will include

  • Collaborate with functional SMEs and CDMOs to plan and execute projects, ensuring timely communication and alignment.
  • Ensure timely, proactive project updates that identify risks, status, opportunities, and mitigation/acceleration strategies.
  • Develop and maintain project 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.
  • Identify, define, prioritize, and communicate risks to successful project execution; develop and monitor risk mitigation and contingency plans.
  • Manage team meetings by including meeting agendas, action plans, and thorough follow-up.
  • Maintain financial accountability for assigned projects ensuring budgets are established, followed, and change controls managed appropriately. Communicate project status to stakeholders and key project participants.
  • Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across functions and programs.
  • Support the management of 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.

How you work and think

  • You thrive in a team-oriented culture.
  • Self-starter who takes ownership and responsibility.
  • Happy to work on a mix of (mostly) fascinating and (also some) mundane.
  • Clear communicator who can distill complex information into concise summaries, options, and recommendations.
  • Growth mindset, valuing transparency and welcoming feedback.

Why you might not like this role

  • This is a fast-paced, rapidly-scaling startup environment.
  • We’re still relatively new, with many systems and processes either not in place or still being developed, so you’ll be expected to tolerate ambiguity and a bit of startup chaos.
  • Development strategy can change rapidly based on science and/or business requirements.
  • We may be comfortable with more ambiguity and uncertainty than you are accustomed to, as we like to test hypotheses early. You’ll need to be comfortable taking full responsibility for your area of expertise, with support and guidance from the rest of the team and company.

What you'll gain from this role

  • Enabling the approval/launch of first longevity drugs approved by the FDA.
  • Working and leading in an entrepreneurial environment that is constructive, kind, and thoughtful.

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.