Senior Director, CMC
7 days ago
Meet is seeking a highly experienced Senior Director, CMC to lead and oversee CMC activities related to drug substance and drug product development, manufacturing, and supply chain. This role requires deep expertise in small molecules pharmaceutical development and commercialization, as well as a strong understanding of regulatory requirements for rare disease therapeutics.
Key Responsibilities- Develop, optimize, and scale-up drug substance and drug product processes to ensure robust and scalable manufacturing processes for clinical and commercial production.
- Ensure all CMC activities comply with regulatory requirements (FDA, EMA, etc.) and industry standards.
- Implement supply chain resources, partners, and procedures related to commercialization.
- Prepare and review CMC sections of regulatory submissions, including IND, BLA, NDA, and MAA.
- Represent the company in regulatory interactions and inspections related to CMC activities.
- Provide technical oversight and manage Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture, and supply of Drug Substance (DS) and Drug Product (DP) in support of ongoing clinical programs through commercialization.
- Ensure efficient, cost-effective manufacturing of drug substance and drug product through commercialization.
- Establish and maintain strong relationships with external partners, including CMOs, CROs, and suppliers.
- Negotiate contracts and manage external vendors to ensure high-quality deliverables.
- Perform demand planning, project execution, supply chain management, and budget management.
- Define and implement external manufacturing policies, business processes, and systems.
- Coordinate cross-functional teams, including R&D, quality, regulatory, and clinical, to support CMC activities.
- Prepare contingency plans as appropriate and communicate issues, risks, and proposed mitigation plans; execute agreed-upon plans in a timely manner.
- Mentor and develop team members, providing guidance and support for professional growth.
- Master's degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or a related scientific discipline.
- Minimum of 10-15 years of experience in CMC drug substance or drug product development and manufacturing, with small molecule experience a must and a focus on commercialization of rare disease products preferred.
- Strong background in outsourced drug substance clinical development through commercialization is required, as is experience in outsourced development through commercialization of solid oral dosage forms, modified-release formulations, and pediatric formulations.
- Substantial experience in managing US CRO/CMOs for the manufacture of cGMP DSs and DPs; experience collaborating with international CROs/CMOs a plus.
- Knowledge of GMP quality systems.
- Strong project leadership presence with excellent organizational skills and strong attention to details; excellent written and verbal communication skills.
- Strong technical judgment; a problem solver with the ability to successfully and proactively identify and manage potential risks across all relevant areas.
- Strong knowledge of regulatory requirements and guidelines for drug development and manufacturing.
- Excellent leadership, communication, and interpersonal skills.
- Ability to work effectively in a fast-paced, dynamic environment.
- Ability to travel as needed.
-
Senior CMC Director
1 month ago
California, United States Meet Full timeTitle: Senior Director, CMCOverview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in guiding and managing CMC initiatives pertaining to the development, manufacturing, and supply chain of drug substances and products. This position...
-
Senior Director, CMC Development Lead
7 days ago
Massachusetts, USA, United States Fraser Dove International Full timeSenior Director, CMC Development LeadFraser Dove International is partnering with a leading healthcare organization to find an experienced leader to oversee CMC Development and lead the manufacturing operations of radiopharmaceutical products.About the RoleAs the Senior Director, CMC Development Lead, you will be responsible for leading multidisciplinary...
-
Director of CMC Operations
1 month ago
California, United States Meet Full timeTitle: Senior Director, CMCOverview: A forward-thinking clinical-stage biopharmaceutical organization is in search of a highly skilled and driven Senior Director, CMC. The ideal candidate will be instrumental in directing and managing CMC functions associated with the development, manufacturing, and supply chain of drug substances and products. This position...
-
CMC Regulatory Affairs Director
2 weeks ago
California, United States Bayside Solutions Full timeJob Title: Director, CMC Regulatory AffairsAt Bayside Solutions, we are seeking a highly experienced Director, CMC Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory strategies and leading the preparation of CMC sections of regulatory...
-
South San Francisco, California, United States Frontier Medicines Full timeSenior Manager/Associate Director, CMC DevelopmentFrontier Medicines is seeking a highly skilled Senior Manager/Associate Director to lead our CMC Development team. As a key member of our organization, you will be responsible for driving the development and manufacturing of drug substances, overseeing internal and external resources, and collaborating...
-
Senior Director of Formulation Development
4 weeks ago
California, United States Barrington James Full timeJob Summary:Barrington James is seeking an experienced Senior Director of Formulation Development to lead the formulation development of solid oral products. As a key member of our team, you will be responsible for advancing projects from early-phase development through late-stage and commercialization.Key Responsibilities:Lead the formulation development of...
-
Senior Director of Supply Chain Operations
3 weeks ago
California, United States Meet Full timeSenior Director, Supply ChainMeet our innovative biotech partner in San Mateo County, seeking a seasoned Senior Director of Supply Chain to spearhead the establishment and leadership of supply chain and distribution as they prepare for commercial launch of programs.Key Responsibilities:Lead the global clinical supply chain to ensure continuous supply for...
-
Senior Director of Analytical Development
4 weeks ago
California, United States The Higgins Group, Inc. Full timeAbout the RoleWe are seeking a highly experienced and skilled professional to lead our Pharmaceutical Development and Manufacturing (PDM) organization as Vice President, Analytical Development & QC. This is a senior leadership role that requires a strong technical background, excellent organizational and strategic leadership skills, and the ability to work...
-
Regulatory Affairs Director
3 weeks ago
California, United States Bayside Solutions Full timeJob Title: Director, CMC Regulatory AffairsAt Bayside Solutions, we are seeking a highly experienced Director, CMC Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory strategies and leading the preparation of CMC sections of regulatory...
-
South San Francisco, California, United States AbbVie Full timeAbout the RoleThe Biologics CMC Development team at AbbVie is seeking a highly skilled Senior Scientist I to join our team in the Bay Area. As a member of our CMC purification development group, you will apply your expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production.Key ResponsibilitiesDevelop,...
-
South San Francisco, California, United States AbbVie Full timeAbout the RoleThe Biologics CMC Development team at AbbVie is seeking a highly experienced Senior Scientist II to lead the development of robust, phase-appropriate processes for drug substance GMP production. As a key member of the team, you will be responsible for all aspects of CMC purification program deliverables and help drive drug substance...
-
Process Chemistry Director
1 week ago
California, USA, United States HireMinds Full timeAssociate Director, Process Chemistry & API DevelopmentHireMinds is partnering with a biotech company focused on peptide drug development to find an experienced Associate Director, Process Chemistry & API Development. This role will support the development of peptide drugs and manage partnerships with contract development and manufacturing organizations...
-
South San Francisco, California, United States AbbVie Full timeAbout the RoleThe Biologics CMC Development team at AbbVie is seeking a highly experienced Senior Scientist II to lead the development of robust, phase-appropriate processes for drug substance GMP production. As a key member of the team, you will be responsible for all aspects of CMC purification program deliverables and help drive drug substance...
-
Senior Director of Analytical Development
3 weeks ago
California, United States The Higgins Group, Inc. Full timeAbout the RoleWe are seeking a highly experienced and skilled professional to join our team as Vice President, Analytical Development & QC. As a key member of our Pharmaceutical Development and Manufacturing organization, you will be responsible for leading analytical development and operations in support of clinical development and commercialization of our...
-
Senior Director of Pharmaceutical Development
2 weeks ago
California, United States The Higgins Group, Inc. Full timeJob Title: Vice President, Drug ProductRevolution Medicines is seeking a highly experienced and skilled Vice President, Drug Product to lead our Pharmaceutical Development and Manufacturing (PDM) organization. As a key member of our team, you will be responsible for formulation development and drug product manufacturing operations in support of clinical...
-
Senior Director of Pharmaceutical Development
3 weeks ago
California, United States The Higgins Group, Inc. Full timeJob Title: Vice President, Drug ProductAbout the Role:We are seeking an experienced and skilled professional to lead our Pharmaceutical Development and Manufacturing (PDM) organization as Vice President, Drug Product. The successful candidate will be responsible for formulation development and drug product manufacturing operations in support of clinical...
-
Senior Director of Pharmaceutical Development
2 weeks ago
California, United States The Higgins Group, Inc. Full timeJob Title: Vice President, Drug ProductRevolution Medicines is seeking a highly experienced and skilled Vice President, Drug Product to lead our Pharmaceutical Development and Manufacturing (PDM) organization. As a key member of our team, you will be responsible for formulation development and drug product manufacturing operations in support of clinical...
-
Resident Care Director
3 weeks ago
California, USA, United States Sunrise Senior Living Full timeJob Title: Resident Care Director - LVNAt Sunrise Senior Living, we are committed to providing high-quality care and services to our residents. We are seeking a skilled and compassionate Resident Care Director - LVN to join our team.Job Summary:The Resident Care Director - LVN is responsible for leading and managing the health and wellness of our residents....
-
Senior Director of Biostatistics
7 days ago
California, USA, United States Barrington James Full timeSenior Director, Biostatistics - Biotech (SAN DIEGO) - ON-SITE / HYBRIDWe are collaborating with a leading Biotech company to find a Senior Director, Biostatistics.The company is working on treatments for rare diseases, with a pipeline including 4 Phase II studies and a pivotal Phase III study.The ideal candidate will have:A Master's or Ph.D. in Statistics...
-
Senior Care Director
2 weeks ago
Walnut Creek, California, United States Kisco Senior Living Full timeJob Overview We are seeking a highly skilled and compassionate Resident Care Manager to join our team at Kisco Senior Living. As a key member of our Assisted Living Department, you will be responsible for directing, coordinating, and supervising care services provided by care associates for our residents. Responsibilities * Monitor and evaluate assigned...
