Senior Director of CMC & DP Manufacturing

Job description — Senior Director of CMC & DP Manufacturing 

Location: Remote US

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 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 Senior Director of CMC & DP Manufacturing who will play a key role in the development of the CMC strategy and execution, and be primarily responsible for manufacturing of Loyal drug products ensuring that all products meet regulatory and quality standards. This role requires a visionary leader with a strong background in pharmaceutical development and commercialization of small molecules  in a partnered environment (working with CDMOs). The Senior Director will oversee all aspects of CMC activities (drug substance, formulation, process and analytical development) and have a direct ownership of process validation and  commercial manufacturing of Loyal's first commercial drug product

You will be reporting to our Senior Vice President, CMC Technical Operations - Jana Spes.

Your daily work will include:

Leadership and Strategy:

• Responsible for development of manufacturing processes for drug products, including formulation, scale-up and validation while overseeing analytical development.
• Contribute to formulation of end-to-end CMC development strategy and  tactical plans ensuring integrated alignment and delivery against Loyal program plans for all CMC activities.
• Apply Quality-by-Design principles to develop robust, scalable manufacturing process technologies and process analytics; build a deep understanding of the  manufacturing processes  (CQAs, CPPs, etc) and lead the development of effective, operational control strategies.
• Lead product validation and commercialization applying proactive risk mitigation strategies to ensure that manufacturing processes are robust,  well controlled and there are no supply disruptions
• Expertly interface and coordinate activities across drug substance, formulation, analytical development, regulatory affairs, quality assurance/control, packaging, and product supply functions to guarantee on-time release and uninterrupted supply of drug products
• Working with a Supply Chain lead and Packaging expert, integrate product manufacturing activities and timelines with drug product packaging to create a seamless product supply according to demand forecast.
• Strengthen the Loyal supply chain capacity by holding CDMOs accountable for delivery  of agreed plans, identifying technical capacity improvements within the supply chain including adding 2nd suppliers as needed. 
• Oversee and contribute to the development and optimization of manufacturing processes for drug substances working with drug substance experts. 

Team Management: 

• Lead and mentor a team of CMC professionals, fostering a culture of excellence, accountability, and continuous improvement.
• CDMO Management: spearhead the technical assessment and flawless execution of CMC strategy utilizing strategic external partnerships. Provide visionary leadership, continuously improve supplier relationships, align on common goals. Ensure there is a strategic direction for each CDMO.
• Collaborate closely with QA and internal stakeholders to methodically evaluate, select, and astutely manage contract service vendors. Drive vendor capability assessment, contribute to contract negotiation and decision making for vendor selection.
• Provided visible technical oversight on routine and non-routine development/GMP activities, including deviations, investigations, CAPA, technical memos, shelf-life extension manufacturing reports, and the approval of manufacturing batch records.
• Regulatory Compliance: Ensure all CMC activities comply with regulatory requirements and industry standards, including  preparation,  submission of regulatory documents and defending manufacturing sections. 

Process Development and Collaboration: 

• Work closely with cross-functional teams, including R&D, Quality, Regulatory Affairs, and external partners, to ensure seamless integration of CMC activities into product development plans.
• Innovation: Stay abreast of emerging trends and technologies in the field of CMC & Manufacturing,  and implement best practices to enhance the company's capabilities.
• Project Management: ensure timely delivery of high-quality results within budget.

About you: 

• A PhD or MSc in relevant life sciences or engineering field with 10+ years  leadership experience in small molecule CMC development from early stages through commercialization.
• Track record of leading  drug product launch (including late stage development, validation , commercial launch) and supporting technical life cycle management (drug substance, raw material changes, site transfers, etc.)
• Skilled in QbD-based development and product validation according to FDA guidelines. Hands on skills in conducting Risk Assessment (FMEA or similar), use of applied statistics to process robustness assessment. 
• Proven experience in managing outsourced CDMO manufacturing, process development, and analytical development functions involving complex manufacturing processes, including tech transfer; experience developing sterile manufacturing processes is a plus
• In-practice knowledge of relevant global regulatory requirements
• Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
• Outstanding communication, analytical and organizational skills
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Ability to navigate and be successful in a dynamic, fast-paced entrepreneurial environment

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.