Director/Senior Director CMC
3 weeks ago
Imagine joining a company where you....
- Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates
- Will work with incredible humans who are committed to the discovery of transformative medicines for patients
- Are needed... because patients are counting on you
MOMA Therapeutics is a biotechnology company focused on developing inhibitors of highly dynamic proteins, namely ATPases, which play critical roles in a variety of Oncology indications.
About the role...
MOMA Therapeutics is seeking a Director/Senior Director of CMC to join our growing development team.
In this role, you will lead drug substance, drug product and analytical development activities, and ensure the delivery of clinical trial supplies across two small molecule programs as they enter clinical development.
You will lead multi-disciplinary CMC teams through preclinical development, IND filings and into clinical development. You will collaborate with internal functions to plan and align on key objectives as development unfolds.You will partner with external organizations and consultants to execute strategically efficient development and manufacturing with an eye toward regulatory milestones.
You will manage CMC program timelines toward key goals and maintain budget oversight for all CMC activities.MOMA's development programs require independence and leadership in a highly dynamic environment.
Your deep technical background, combined with leadership and an ability solve scientific problems under pressure will be fundamental to operating in this role.
Your ability to build relationships, both internally and externally, and operate in a lean environment will enable success for you and our programs.
In this role you will...- Lead small molecule CMC teams comprised of technical leads and key stakeholders
- Establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team
- Oversee the execution of CMCrelated development and manufacturing activities at external manufacturing partners, including technology transfer and onsite management
- Guide the authoring of regulatory filings in terms of substance and scope
- Identify CMC program risks and work with the CMC team to develop contingency plans
- Represent the CMC function at the program level and collaborate to develop program strategies
- Forge close working relationships across disciplines and with external partners and consultants to advance programs through clinical development
- You have at least 10 years of experience in small molecule CMC, including experience in an earlystage biotechnology company
- You have experience effectively collaborating with and managing CDMOs
- You have experience authoring regulatory filings including INDs
- You are familiar with solid oral dosage form development
- You have a working knowledge of regulations and guidelines for small molecule development
- You've led teams and/or projects in a dynamic fast paced environment
- You have explicit achievements that indicate your effectiveness
- You're organized and have excellent written and verbal communication skills
- You understand relationships are the key component of achieving significant results
- You know how to make decisions independently
- Subject matter expertise in Drug Product or Analytical method development is a plus
- You have an advanced degree (MS/Ph.
- You work hard, you are kind to others, and you enjoy being a part of a collaborative team that gets stuff done in an environment where scientific data rules the day
MOMA Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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