Senior Manager, CMC Analytics

Loyal; United States; Remote; USD 140,000 - 170,000; Full time

Job summary

An innovative clinical-stage veterinary medicine company is seeking a Sr. Manager, CMC Analytics to lead analytical method development and ensure quality controls for drug products. This role is pivotal in supporting the company's growth strategies and involves collaboration with partners on investigations and ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in method development for small molecules and a passion for improving the health and lifespan of dogs. Join a dynamic team that values creativity, problem-solving, and a commitment to making a meaningful impact in veterinary medicine.

Benefits

Full-coverage health insurance

$1,000 home office equipment stipend

$250/month wellness budget

3-day weekends turned into 4-day weekends

Unlimited vacation and paid holidays

Paw-ternity leave

Annual company retreat

Company equity options grant

Qualifications

• 10+ years of experience in analytical method development for small molecules.
• Experience managing CDMO relationships and overseeing Quality Control programs.

Responsibilities

• Lead analytical development activities and ensure quality controls are in place.
• Oversee method development and validation for drug products and APIs.

Skills

Analytical Chemistry

Method Development

Problem-Solving

Communication Skills

Project Management

Regulatory Knowledge

Education

Bachelor's Degree in Analytical Chemistry

Master's or Ph.D. in Chemistry

Tools

Google Workspace

Job description

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 Sr. Manager, CMC Analytics to help oversee analytical method development for API and drug products and oversee testing from product development through commercialization. Your work will ensure proper controls for API and drug product development and QC testing are in place.

This role is for someone who has extensive experience with method development for small molecule drug product and API testing, particularly with new chemical entities. The ideal candidate should have extensive method development in various techniques, experience overseeing development as a group leader or managing outside labs, and the ability to critically review all data for potential trends or issues.

You will be reporting to our Sr. Director, CMC Analytics.

Your daily work will include:

• Lead analytical development activities, validation and GMP testing for products in the Loyal portfolio.
• Represent the analytical group in CMC meetings and provide updates on ongoing activities.
• Work with our partners on investigations to ensure proper and timely solutions. Implement CAPAs as needed.
• Oversee the development, optimization and validation of analytical methods at CDMOs for release and characterization of starting materials, intermediates, active pharmaceutical ingredients and drug product candidates.
• Ensure quality and accuracy of raw data provided by our partners.
• Establish specifications for API and drug products to be in line with current regulations while working with the Regulatory CMC group.
• Stay abreast of industry trends and FDA CVM developments with a focus on innovation in the analytical space and CVM expectations for scientific rigor in development and data presentation.

About you:

• A Bachelor’s or Advanced degree (master’s or Ph.D.) in Analytical Chemistry, Chemistry, or a related field.
• A minimum of 10 years of experience in analytical development method development, with significant experience in small molecules.
• Deep and broad knowledge of analytical chemistry in support of small molecule release and stability method development, raw material control, in-process control, and characterization.
• Prior experience managing CDMO relationships, tech transfer, and Quality Control programs desired.
• Creative and thoughtful approach to problem-solving technical issues.
• Ability to quickly learn new concepts and processes.
• Adaptability, creativity and high performance in risk assessment and strategic thinking.
• Detailed eye for logistics and problem-solving.
• Willing to work and comfortable in a fast-paced startup environment with a dynamic team.
• Clear and polite communication skills.
• Familiarity with Google Workspace applications (e.g., Sheets, Slides, etc.).

Compensation and Benefits:

• Full-coverage health insurance — medical, dental and vision — for you and your dependents.
• $1,000 home office equipment stipend.
• $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).
• Company equity options grant for new hires.

Salary Range: $140,000 - $170,000

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.

Our values

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.

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