Director/Associate Director CMC Program Leadership

2 weeks ago

Cambridge, United States Momatx Full time

MOMA Therapeutics is looking for an experienced

CMC Director/Senior Director.

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

About MOMA Therapeutics

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. Our platform allows us to successfully prosecute drug discovery against difficult and unprecedented targets which are core cancer dependencies. MOMA is planning to initiate clinical development for two programs in 2024.

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 CMC-related development and manufacturing activities at external manufacturing partners, including technology transfer and on-site 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

About you…

You have at least 10 years of experience in small molecule CMC, including experience in an early-stage 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.D. or equivalent) in chemistry, pharmaceutical sciences or a relevant discipline

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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