Loyal is an early stage company developing drugs to help dogs live longer, healthier lives. We apply innovative approaches to tackling aging as a disease that can be slowed and improved with medicines. Loyal is an early stage start-up company and is well funded by top venture capitalists and angels. Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants.
Loyal is looking for an ambitious scientist to assist our CMC & Formulation team. This is an excellent opportunity for a Formulation Scientist to help in building a team from the ground up. Your team will drive all aspects of drug development and manufacturing.
As Part of the CMC Team You Will Be
Assisting the planning and execution of drug product development from pre-formulation, formulation development and characterization, production of pre-clinical and clinical trial materials.
Developing formulations alongside Contract Development and Manufacturing Organizations (CDMOs).
May include overseeing and performing hands-on development experiments for drug product formulations in our in-house lab.
Manage collaborations with Contract Development and Manufacturing Organizations (CDMOs)
Identification and selection of technically competent CDMOs
Negotiation of supply and service agreementsTechnical due diligence of CDMO proposals, protocols, data and reports
Strategic and tactical input to the overall product development plans including raw material sourcing, formulation development, quality, and manufacturing aspects.
Proactively identifying issues, risks, and opportunities to improve and optimize product development and manufacturing processes
Authoring/reviewing CMC sections for regulatory filings and, if requested, interacts with regulatory agencies to answer questions
Help in building out the team as needed, this is your chance start from the ground floor and build in your vision
You have a Bachelor’s in Chemistry, Chemical Engineering, or related physical science
2+ years of experience in a similar role and demonstrated successful track record of executing drug product development
You have experience managing CDMOs or equivalent
You have industry expertise in key CMC areas such as various types of API synthesis, formulation development and GMP production, and analytical development.
Comfortable with developing multiple types of delivery systems - not just oral
How You Work & Think
Adaptability, creativity and high-performer in risk-assessment and strategic thinking
You have a track record of operating - as the team grows, you will be helping to design and then execute on your strategy
Detailed eye for logistics and problem solving
Startup mindset: work fast, low ego, comfortable with uncertainty, and collaborative
You are comfortable managing others- laterally, up, and direct reports
The Fundamentality of Health | Good health is critical to every other human (and animal!) experience. We believe health is a fundamental right and are dedicating our lives to maximizing health and developing better medicines for the worst diseases.
Truth Seeking & Feedback Loops | Uniquely in biology, there is a predetermined truth of whether a specific drug will work or not — we just have to catch up with biology! We seek out this truth and do not shy away from inconvenient truths. This holds for personal development too: we are always searching for feedback loops and embody a perpetual growth mindset.
Morality & Empathy | We are developing medicines that may one day be given to a living animal, medicines that if designed badly could hurt that animal instead of help. This is a huge responsibility and should be respected as such. Our work needs to adhere to the strictest moral code and always integrate empathy for the patient.
Transparency | We believe full transparency in thoughts, opinions, intentions, and actions (both good ones and mistakes) is a better way to build a business and work together.
Kindness | Great business(wo)men do not need to be ruthless — you can execute excellently with kindness.