-
Regulatory CMC Director
2 weeks ago
Dennis Partners Boston, United StatesOur client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug pr ...
-
Director, Regulatory CMC
1 week ago
Kelly Flores Boston, United StatesSummary of Position: · The Director Regulatory CMC will be responsible for developing and delivering innovative regulatory CMC strategies for product development and approval. With limited guidance from the EVP Regulatory Affairs & Quality Assurance, the incumbent acts as the r ...
-
Director, CMC Operations
1 week ago
Taylor Strategy Partners Boston, United StatesInterested in joining a clinical-stage biotechnology company, focused on bringing new generation adjuvanted subunit vaccines to market? We combine excellence in protein and adjuvant biology to create vaccines of global importance. · Curevo Vaccine is dedicated to developing next ...
-
Regulatory CMC Director or Associate Director
3 weeks ago
Dennis Partners Boston, United StatesOur client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage ...
-
Director, Regulatory CMC, Cell
1 week ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory g ...
-
Senior Director, Regulatory CMC
2 weeks ago
X4 Pharmaceuticals Boston, United StatesSenior Director, Regulatory CMC · Reporting to: · Vice President, Regulatory Affairs · Do you have the passion and commitment to join a group whose mission is to develop treatments that have a clear and profound impact on patients suffering from rare diseases? Does it excite y ...
-
Director, Regulatory Affairs Vaccines CMC
2 weeks ago
Takeda Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Director, Regulatory Affairs Vaccines CMC
1 week ago
Takeda Pharmaceutical Company Ltd Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Director, Regulatory Affairs Vaccines CMC
2 weeks ago
Takeda Pharmaceutical Company Ltd Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Associate Director, CMC Biologics Drug Product
3 weeks ago
Stratacuity Boston, United StatesAssociate Director, CMC Biologics Drug Product Location: Newton, MA (Onsite) Science: Monoclonal antibody therapeutics Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners to oversee and plan CMC development ...
-
Apex Systems Boston, United StatesJob#: · Job Description: · Associate Director, CMC Biologics Drug Product · Location: Newton, MA (Onsite) · Science: Monoclonal antibody therapeutics · Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners ...
-
Associate Director, CMC Biologics Drug Product
3 weeks ago
Apex Systems Boston, United StatesAssociate Director, CMC Biologics Drug Product · Location: Newton, MA (Onsite) · Science: Monoclonal antibody therapeutics · Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners to oversee and plan CMC ...
-
Associate Director, CMC Biologics Drug Product
3 weeks ago
Professional Diversity Network Boston, United StatesJob#: · Job Description · Associate Director, CMC Biologics Drug Product · Location: · Newton, MA (Onsite) · Science: Monoclonal antibody therapeutics · Job Overview: · The Associate Director will lead CMC development activities and collaborate with internal and external pa ...
-
Sr. Manager/Associate Director, CMC Development
3 weeks ago
Frontier Medicines Boston, United StatesJoin Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office. · As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role i ...
-
Sr. Manager/Associate Director, CMC Development
2 weeks ago
Frontier Medicines Boston, United StatesJob Description · Job Description · Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office. · As a crucial member of our team, reporting directly to the Head o ...
-
Sr. Manager/Associate Director, CMC Development
3 weeks ago
Internetwork Expert Inc Boston, United StatesJoin Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office. · As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role in ...
-
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Associate Director, Regulatory CMC executes multi-product global regulatory CMC strategies for cell therapy combination investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and man ...
-
EPM Scientific Boston, United StatesDirector Analytical Development – Medical Devices · Location: San Franciso, CA · Working situation: Hybrid · Level: Director · Our client is a novel biologics company pursuing research into exciting combination products and therapies looking for a Director Analytical Development ...
-
Senior Director, GRA Pharmaceuticals
1 week ago
BioSpace Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
-
Director, Drug Substance Manufacturing
3 weeks ago
Third Rock Ventures Boston, United StatesAs a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximall ...
Director, CMC - Boston, United States - Zevra Therapeutics
2 weeks ago
Description
Job Description
The Director, CMC will develop and manage manufacturing and packaging operations for clinical and commercial drug substance and drug products at contract manufacturing (CMO) facilities.
Job Responsibilities
· Manage and interface with CMOs (including person-in-plant (PIP) activities as needed) to ensure drug substance, finished dosage form and related primary packaging operations are completed in compliance with cGMP requirements.
· Assist with development, review and execution of Supply/Service Agreements and Quality Agreements in coordination with Legal and Quality Assurance
· Interface with Quality Assurance, Clinical/Medical, Supply Chain, and Commercial teams to ensure manufacture of required quantities and timely delivery to meet clinical and commercial demands.
· Establish and manage appropriate timelines and deadlines for both internal and external manufacturing tasks.
· Ensure development and/or technical review of manufacturing documents (batch records, formulation/process data, analytical methods, protocols, reports).
· Provide manufacturing expertise to CMOs during manufacturing campaigns including assistance with troubleshooting as needed.
· Identify manufacturing problems and initiate/coordinate manufacturing investigations with Quality Assurance
· Review technical information for different manufacturing operations and assess deviations. Review routine reports, Non-Conformance and Corrective Action and preventive Action (CAPA). Support internal Quality function with writing and review of internal change management documents.
· Coordinate and plan strategy for continuous process optimization
· Compile CMC related information and draft CMC sections of regulatory submissions
Job Requirements
· A minimum of 8-10 years of pharma/biotech industry experience in drug development including experience in clinical drug development, commercialization, and regulatory knowledge. Minimum of 5-7 years' experience managing CMOs.
· BS or equivalent experience in Chemistry, Biology, Biochemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. Masters or Doctorate degrees a plus.
· Strong scientific knowledge and understanding of product development with relevance to pharmaceutical manufacturing including API chemical synthesis, drug product manufacturing, and packaging.
· Knowledge of GMP regulations, ICH guidelines; as well as CMC content of regulatory submissions.
· Knowledge of appropriate analytical methodology used in product characterization
· Familiarity with pharmaceutical supply chain management
· Displays sense of urgency to resolve problems that arise during drug development and manufacturing. Able to develop solutions to complex problems and influence resolution both internally and externally.
· Strong verbal and written communication with solid organizational, time management, and project management skills.
· Ability to work collaboratively, respectfully, and effectively with others.
· Flexible schedule to accommodate regular telecons with CMOs and travel to respective CMO sites.
