REMIX Therapeutics is seeking a highly motivated, experienced CMC professional who will be responsible for leading all CMC-related activities. The individual will be accountable for setting CMC strategy, management of CDMOs, and representing all aspects of CMC, including drug substance, drug product and analytical activities. The successful candidate will have prior experience leading small molecule CMC activities within a biotechnology and/or pharmaceutical company from lead optimization through to late phase development and will demonstrate strong communication skills, work effectively in a dynamic, matrix team environment, and demonstrate creativity, flexibility, initiative, and independence.
- Set CMC strategy for Remix project teams and manage CMC timelines and budget.
- Lead all small molecule CMC-related activities including drug substance, drug product and analytical development from lead optimization through to late phase development.
- Manage drug substance and drug product CDMOs supply chains to support IND enabling studies and clinical trial development including appropriate oversight and manufacturing under cGMP conditions.
- Implement CMC SOPs and training. Spearhead CDMO selection process and contract negotiation, interact with the Quality function and represent the company at audits of CDMOs.
- Accountable for the writing of high-quality regulatory CMC documents for regulatory and health authorities in compliance with cGMP and local authorities’ requirements.
- Author regulatory CMC documents for IND and other regulatory submissions. Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Assess and communicate CMC regulatory requirements to ensure all development and clinical activities are in compliance with applicable regulations and guidelines.
- Serve as subject matter expert to both preclinical and development project teams at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
- Provide creative and innovative solutions while being an advocate for compliance.
- Proactively manage issues and information sharing with key internal and external stakeholders.
- PhD in Pharmaceutical Science or equivalent.
- Candidate must have 10+ years of experience of small molecule CMC projects, including direct hands-on experience with small molecules and successful management of CDMOs.
- Experience in startup biotech and/or large pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions.
- Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU. Strong written and oral communication skills.
Remix values diversity and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, marital or veteran status, genetic information, sexual orientation or any other legally protected status. Remix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Note to Third Party Staffing Agencies: Please do not forward any agency resumes. Remix Therapeutics is not responsible for any fees related to resumes that are unsolicited.