- Boehringer Ingelheim (Ridgefield, CT)
- …a highly skilled and experienced Director to join our External Alternative CMC Development (EACD) team. The ideal candidate will have expertise in drug ... collaborations with Contract Development and Manufacturing Organizations (CDMOs). The Director will support all drug product-related CMC activities within… more
- Boehringer Ingelheim (Ridgefield, CT)
- …position can support projects of increasing regulatory complexity and/or business impact. The Senior Associate Director , US Product CMC Regulatory Affairs is ... relevant topics. Additionally, with support and guidance from the Sr . Associate Director / Director ,...DMF Annual Report on behalf of the DMF Holder. CMC Development : + Provides US CMC… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages ... strategies for both development and commercial products. Additionally, the Senior Director is committed to fostering continuous improvement in regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …proficient understanding of scientific principles and profound grasp of global regulatory CMC requirements relevant to global drug development and post-market ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- BeiGene (Harrisburg, PA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...needed throughout product lifecycle. Escalate the critical issues to senior management timely. * Lead or/and oversee the establishment… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. ... respective development stage of the project. The CMC Lead will support the Sr . ...and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status… more
- Merck (North Wales, PA)
- …+ Industry / regulatory experience in pharmaceutical or combination product research, development and/or manufacturing + Experience with CMC regulatory where ... Description** This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from a Director , the Associate… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director / Senior Manager) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... faster and more efficiently. As an Associate Director / Senior Manager Product Owner for in silico CMC...company is a strong plus + Knowledge of software development for chemistry applications is a plus **Key skills:**… more
- Lilly (Indianapolis, IN)
- …development cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected ... life better for people around the world. The Synthetic Molecule Design and Development (SMDD) is responsible for the development of synthetic drug substances… more
- Lilly (Indianapolis, IN)
- …to enable faster delivery of significant technical agendas. The Sr . Director leads cross functional manufacturing/quality peers and senior management teams ... for people around the world. **Position Brand Description:** The Sr . Director Portfolio Management role is responsible...degree + Experience with and the knowledge of the CMC aspects of drug development and manufacturing… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …relevant industry experience + Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug ... their teams in the field of analytical controls and compliance + Global CMC program oversight of Pharmaceutical Sciences (PS) with management and oversight of all… more
- Lilly (Indianapolis, IN)
- …people around the world. **Organizational Overview:** The Synthetic Molecule Design and Development (SMDD) team is involved in key activities for the development ... expertise to accelerate testing of the clinical hypothesis and overall drug development . SMDD delivers on these responsibilities by recognizing diverse talent and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …market. + The successful candidate will form strong partnerships with the CMC organisation, ensuring the appropriate development , manufacturing, and testing ... is looking to hire Global Program Leaders (GPLs) to support drug development programs across its therapeutic areas (Immunology, Pulmonlogy, Infectious Disease or… more
- Lilly (Indianapolis, IN)
- …Development (SMDD) is comprised of different groups that design and execute the development of all CMC aspects of synthetic molecules from pre-clinical phases ... team of scientists and team leaders support the portfolio from pre-clinical development through the commercialization of new drug candidates. Teams of cross… more
- AbbVie (North Chicago, IL)
- …This will be in collaboration with our CMC team, CMC Product Development Director , and Delivery System Senior Leadership. Your role will be pivotal ... instructions for use, and labeling. You will manage product development timelines and scopes to support CMC ...product development timelines and scopes to support CMC gate reviews and clinical phase plans. Collaboration with… more
- Takeda Pharmaceuticals (Boston, MA)
- … senior -level CMC experts to advise Pharm Sci teams towards winning CMC development strategies. In collaboration with Head of Pharm Sci, R&D Therapeutic ... cycle times to accelerate drug to patients. **Accountabilities:** + Senior level R&D CMC portfolio strategy leader...Sci Portfolio Strategy. Able to clearly articulate deep technical CMC development plans and concepts to a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director in Biologics Analytical Development (Pivotal and ... Commercial)** **Foster City, CA** The ** Senior Director in Biologics Analytical Development (Pivotal and Commercial** ) will be responsible for leading… more
- Sumitomo Pharma (Marlborough, MA)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Director , Business Development .** The Senior ... Business Development will report to the Executive Director (ED) of Business Development and play...alliance programs within North America + Work with commercial, development , CMC and other stakeholders to help… more
- AbbVie (North Chicago, IL)
- …executed deals, coordinate with Development Sciences leadership to identify Product Development Director , and drive the knowledge transfer process with the ... + Possess the technical and scientific understanding to generate a comprehensive CMC development strategy, balancing technical and operational risks and… more