- Location : San Francisco, CA
- Working situation : Hybrid
- Level : Director
- Develop and execute a visionary development strategy aligned with our client's mission and goals, driving them closer to revolutionizing novel brain health therapies
- Lead a team of 3-5 direct reports that will participate in
- strategy, planning, and execution; provide regulatory documentation for all phases of clinical trials and commercialization; and play a role in
- Define and plan out strategies for development from Phase I to commercialization phases of the drug lifecycle
- Leverage your proficiency in small molecule drug development to drive and execute CMC development plans to support cGMP manufacturing
- Prepare and defend CMC regulatory documents enabling global filings
- Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, quality, IP) to accomplish program goals
- Facilitate effective communication channels with external CDMOs/CMOs, providing clear project objectives, timelines, and expectations to partners, and actively participate in joint planning and decision-making processes for new drug substance synthesis
- 8+ years of experience with small molecules
- 8+ years of experience in contributing to CMC efforts from Phase I to Phase III (desired)
- Bachelor's Degree with 16+ years, OR Master's Degree with 13+ years, OR Ph.D. with 10+ years of industry experience
- Competitive 401K program, health insurance, and HSA accounts
- Long-term incentives in terms of equity or stock at this level
- Hybrid role
- Paid holidays per year and Winter Break (typically between Christmas and New Year's Day)
-
Regulatory CMC Executive Director or Senior Director
Found in: Lensa US 4 C2 - 2 days ago
Dennis Partners San Francisco, CA, United StatesThis clinical-stage biotechnology company is developing potentially curative therapies for heart disease. They are seeking a Regulatory CMC Executive Director or Senior Director to lead CMC Regulatory strategies and execution for their portfolio of programs. Reporting into the SV ...
-
Director CMC
Found in: Appcast Linkedin GBL C2 - 3 days ago
Neurocentria, Inc. Walnut Creek, United StatesThe CMC Director of Drug Substance Development and Manufacturing is primarily responsible for the development and manufacturing of small molecule drug substances in support of clinical development and commercialization of Neurocentria's pipeline compounds. The individual will pro ...
-
Director CMC
Found in: Lensa US 4 C2 - 3 days ago
Neurocentria Inc Walnut Creek, United StatesThe CMC Director of Drug Substance Development and Manufacturing is primarily responsible for the development and manufacturing of small molecule drug substances in support of clinical development and commercialization of Neurocentrias pipeline compounds. The individual will prov ...
-
Director CMC
Found in: Jooble US O C2 - 2 days ago
Neurocentria, Inc. Walnut Creek, CA, United StatesThe CMC Director of Drug Substance Development and Manufacturing is primarily responsible for the development and manufacturing of small molecule drug substances in support of clinical development and commercialization of Neurocentria's pipeline compounds. The individual will p ...
-
Director, CMC Analytical
Found in: beBee S2 US - 1 week ago
Maze Therapeutics South San Francisco, United States Full timeThe Position: · Join us at Maze Therapeutics as our Director of CMC Analytical and become a pivotal part of our Technical Operations leadership team. You will be at the forefront of crafting and executing analytical strategies for our early-phase small molecule programs, driving ...
-
Director, CMC Project Management
Found in: Lensa US 4 C2 - 3 days ago
ORIC Pharmaceuticals Inc South San Francisco, United StatesPharmaceutical Sciences/CMCSouth San Francisco,CaliforniaSan Diego,California · ORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients' lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are s ...
-
Associate Director, Program Management, CMC
Found in: Lensa US 4 C2 - 2 days ago
Ultragenyx Pharmaceutical Brisbane, United StatesWhy Join Us? · Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare di ...
-
Associate Director, Program Management, CMC
Found in: Lensa US 4 C2 - 5 days ago
Ultragenyx Pharmaceutical Brisbane, United StatesWhy Join Us? · Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare di ...
-
Director, CMC Project Management
Found in: Lensa US 4 C2 - 4 days ago
ORIC Pharmaceuticals Inc South San Francisco, United States· ORIC Pharmaceuticals, Inc, is a clinical stage oncology company dedicated to improving patients' lives and focused on developing treatments that address mechanisms of therapeutic resistance. We are seeking an effective cross-functional and inter-institution leader with a prove ...
-
associate director, cmc analytical development
Found in: MyJobHelper US C2 - 2 days ago
Alumis Inc. South San Francisco, CA , USA, United StatesAlumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the ou ...
-
Director, CMC Regulatory Affairs
Found in: Appcast US C2 - 3 days ago
Bayside Solutions Fremont, United StatesDirector, CMC Regulatory Affairs · Direct Hire Fulltime Role · Salary Range: $208,000 - $235,000 per year · Location: Redwood City, CA - Hybrid Role · Job Summary: · The position is responsible for providing CMC regulatory strategies and leading the preparation of CMC sections of ...
-
Associate Director, CMC Regulatory
Found in: Lensa US 4 C2 - 6 days ago
Cargo Therapeutics San Carlos, United States· Reporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. · The successful candidate will have a strong background in regulatory CMC with deep expertise in bio ...
-
Senior Director, CMC Regulatory Affairs
Found in: Lensa US 4 C2 - 5 days ago
Allogene Therapeutics South San Francisco, United StatesJob Description · About Allogene: · Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) products for cancer and autoimmune disease. Led ...
-
Associate Director, CMC Analytical Development
Found in: ZipRecruiter Test10S US C2 - 3 days ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer ...
-
Associate Director, CMC Regulatory
Found in: Lensa US 4 C2 - 6 days ago
Cargo Therapeutics, Inc. San Carlos, United StatesReporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. · The successful candidate will have a strong background in regulatory CMC with deep expertise in biologi ...
-
Executive Director, Cell Therapy CMC
Found in: Jooble US O C2 - 2 days ago
BeiGene Emeryville, CA, United StatesWe are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy team to enable the cell therapy development. Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will spea ...
-
Associate Director, CMC Regulatory Affairs
Found in: Lensa US 4 C2 - 5 days ago
Mirum Pharmaceuticals San Mateo, United StatesMISSION · Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and m ...
-
director, cmc biologics, drug product development
Found in: MyJobHelper US C2 - 2 days ago
AbbVie, Inc South San Francisco, CA , USA, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas ...
-
Executive Director, Regulatory Affairs CMC
Found in: Lensa US 4 C2 - 5 days ago
Allakos Inc Redwood City, United StatesExec Director Regulatory Affairs/CMC · Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. · The Executive Director, CMC Regulatory Affairs is responsible for devel ...
-
Director, Clinical CMC Team Leader
Found in: Lensa US 4 C2 - 5 days ago
BioMarin Pharmaceutical Novato, United States**Director, Clinical CMC Team Leader** · **Location** Novato, California **Workstyle** Open to Hybrid BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target ...
Director CMC - San Francisco, CA, United States - EPM Scientific - Phaidon International
Found in: Lensa US 4 C2 - 2 days ago
Description
Director of CMC
Our client, a blooming biotechnology company, is looking to expand their R&D capacity to support their growing pipeline including a new class of brain therapies. With a passion for treating neurodegenerative and neuropsychiatric disorders, they are at the forefront of groundbreaking discoveries in the neurology space. As the Director of CMC, you will be a key architect in shaping the future of neurological treatment.
The Director of CMC will lead a team in the development and manufacturing of small molecule drug substances. Your expertise will drive the successful progression of drug development programs, making a significant impact on patients' lives worldwide.
The Director of CMC will:
The Director of CMC has the following qualifications:
Company Benefits:
If you are passionate about advancing neurological treatments through development excellence and excel in leadership roles, we encourage you to seize this chance. Embark on this transformative journey by applying today
#J-18808-Ljbffr