Senior Director/Vice President, CMC
Full Time | Remote , San Francisco
Send your resume and a short introduction to: firstname.lastname@example.org
Loyal is an early stage company developing drugs to help dogs live longer, healthier lives. Loyal is hiring a Senior Director/Vice President, CMC. You’ll join the leadership team at Loyal to ensure that CMC activities are executed efficiently to a very high quality bar.
We are seeking an outstanding leader in Chemistry Manufacturing and Controls (CMC) with extensive experience in manufacturing and advancing small molecules and long-acting implants/depots through clinical trials to approval.
The ideal candidate is one who has been involved in all aspects of drug substance (API) and drug product (DP) manufacture including through CDMOs and who can direct and oversee CMC regulatory strategy for multiple products. You will work closely with the R&D, clinical and regulatory team to deliver products to the market. This is a great role for someone who is excited by start-up culture and applying knowledge of industry standards alongside novel claims and development programs. You can learn more about our culture and working at a startup here.
Loyal is founded and led by a first-gen, female CEO – we encourage and look forward to diverse applicants.
Your work may include:
Management and direction of CMC activities and team
Formulation development including for long acting implants/depots, working with CROs
Identifying, selecting, and managing Contract Manufacturing Organizations (CMOs) for process optimization, nonGMP and cGMP manufacture and supply of APIs and DPs
Assuring suitable forecasts of API and DP needs for preclinical and clinical programs to ensure uninterrupted drug supply. Managing and overseeing the supply chain.
Authoring, reviewing, and editing CMC regulatory submissions and quality documents.
Maintaining internal standards, processes and systems for CMC
Developing, preparing, and characterizing formulations using CROs
Developing small molecule drug substance supply strategy, timelines and risk mitigation strategies for all process development and manufacturing campaigns for early phase through development and to commercial manufacture.
Develop in-process control strategies, normal operating and proven acceptable ranges, starting material, intermediate and drug substance specifications based on sound scientific and regulatory principles.
Drive selection of strategic analytical and packaging partners. Negotiate service agreements and related statements of work for development activities with external partners.
Identify and source novel compounds to address selected targets by mining patents, literature and public information, and then reaching out to companies with suitable substrate.
Preparing patents sections for formulation, composition of matter and manufacturing methods.
Education and Work Experience
PhD/MS in science (e.g., organic chemistry, chemistry, pharmaceutical sciences, or related discipline)
Preferably have experience ideating and developing novel formulation strategies
Knowledge of GMP and FDA regulatory requirements, preferably also regulatory requirements for CMC packages for other countries
Experience in all aspects of DP and DS manufacture including selection and management of CROs/CMOs, manufacturing of API under cGMP conditions, development of formulation strategies, and implementation of analytical methods consistent with regulatory guidelines
Experience in authoring and reviewing drug substance development reports, batch records and CMC sections for regulatory submission.
Experience in supply chain management is desirable but not essential
Experience with Animal Health product development is desirable but not essential
How You Work & Think
You are flexible, open-minded, and have a positive mindset toward working in the fast-paced and rapidly evolving start-up environment.
You are able to give and receive feedback constructively, you encourage your team during challenges, and celebrate wins whenever possible.
You are detail oriented, thrive in the minutia, responsive, and enjoy high-responsibility environments
You have exceptional integrity as well as excellent attention to detail, personal organization, and communication, presentation, and interpersonal skills.
You have a high degree of compassion, curiosity, and personal drive.
May be based remotely with ability to travel as needed.
Full coverage health/dental/vision
Monthly education/learning allowance/budget for books and self-improvement