Current jobs related to Associate Director/Director, CMC Program Leadership - Cambridge - MOMA Therapeutics
-
Director/Senior Director CMC
1 month ago
Cambridge, United States tapwage Full timeMOMA 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...
-
Director/Senior Director CMC
4 weeks ago
Cambridge, Massachusetts, United States tapwage Full timeMOMA 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...
-
Associate Director, Regulatory CMC
4 months ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Associate Director, Regulatory CMC
4 months ago
Cambridge, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Director, Regulatory Affairs CMC
3 days ago
Cambridge, Massachusetts, United States Takeda Full timeRegulatory Affairs Director, Small MoleculesTakeda is seeking a highly experienced Regulatory Affairs Director, Small Molecules to lead our Global Regulatory Affairs CMC team. As a key member of our team, you will be responsible for overseeing the development and execution of regulatory CMC development and registration strategies.Key Responsibilities:Plan,...
-
Director, GRA CMC Small Molecules
2 weeks ago
cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Director, GRA CMC Small Molecules
2 weeks ago
Cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Director, GRA CMC Small Molecules
3 weeks ago
Cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Senior Director/Vice President, CMC
7 days ago
Cambridge, Massachusetts, United States Repertoire Immune Medicines Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Director/Vice President, CMC to join our team at Repertoire Immune Medicines. As a key member of our organization, you will be responsible for advancing our TCR bispecific therapies from lead candidate to clinical development.Key ResponsibilitiesProcess Development and Optimization: Build...
-
Senior Director/Vice President, CMC
2 weeks ago
Cambridge, Massachusetts, United States Repertoire Immune Medicines Full timeJob DescriptionWe are seeking a highly experienced and skilled Senior Director/Vice President, CMC to join our team at Repertoire Immune Medicines. This is a unique opportunity to lead our CMC efforts and contribute to the development of novel targeted immune medicines.Key ResponsibilitiesBuild and lead effective CMC Teams to develop and optimize upstream...
-
Senior Director CMC Technical Innovation
2 weeks ago
Cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director of CMC Technical Innovation
4 days ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeSenior Director CMC Technical InnovationProclinical is seeking a seasoned professional to lead our CMC Technical Innovation team in Gene Therapies. This role requires a unique blend of technical expertise, effective communication, and business acumen.Key Responsibilities:Develop and implement a centralized innovation framework to drive technical advancements...
-
Senior Director CMC Technical Innovation
7 days ago
cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director CMC Technical Innovation
2 weeks ago
cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director CMC Technical Innovation
1 week ago
Cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director CMC Technical Innovation
2 weeks ago
Cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Associate Director, CMC MBA Accelerator Program
1 month ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe RoleAt Moderna, our mission isto deliver the greatest possible impact to people through mRNA medicines. Our focus is to use our mRNA platform and the infrastructure we have built to deliver a new generation of transformative medicines for patients.Moderna is seeking trailblazers for our 18-month MBA Accelerator Program. This program is designed to be an...
-
Associate Director, CMC MBA Accelerator Program
4 weeks ago
Cambridge, United States Moderna, Inc. Full timeThe RoleAt Moderna, our mission isto deliver the greatest possible impact to people through mRNA medicines. Our focus is to use our mRNA platform and the infrastructure we have built to deliver a new generation of transformative medicines for patients.Moderna is seeking trailblazers for our 18-month MBA Accelerator Program. This program is designed to be an...
-
Senior CMC Director
2 weeks ago
Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full timeMEDIPOST America, Inc. is a prominent umbilical cord blood banking and cellular therapy organization. Our mission is to pioneer advanced stem cell treatments aimed at combating degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, represents the first-ever stem cell therapy designed for...
-
Senior CMC Director
2 weeks ago
Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full timeMEDIPOST America, Inc. is a prominent player in the field of umbilical cord blood banking and cellular therapies. Our mission is to pioneer innovative stem cell treatments aimed at combating degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, represents a groundbreaking advancement as...
Associate Director/Director, CMC Program Leadership
4 months ago
MOMA Therapeutics is looking for an experienced Associate Director/Director, CMC Program Leadership
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 an Associate Director/Director of CMC Project Leadership to join our growing development team as we drive two small molecule programs into clinical development. In this role, you will lead small molecule CMC teams consisting of technical leads and other key stakeholders through preclinical development, IND filings and into clinical development. You will help establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team and the head of CMC. You'll oversee the execution of CMC-related development and manufacturing activities at external manufacturing partners. When risks to the CMC program arise, you'll identify them and work with the CMC team to develop contingency plans. You will represent the CMC function at the program level and collaborate to develop the overall program strategy.
MOMA's development programs require independence in a highly dynamic environment. Your ability solve address 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* Help to establish CMC program strategy, including key activities, timelines, and budgets, in collaboration with technical experts on your team and the head of CMC* 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 7 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 drive a group to make a decision* 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, pharmaceuticals 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.
#J-18808-Ljbffr
