- Bristol Myers Squibb (Princeton, NJ)
- …patients while advancing professionally alongside some of the brightest minds in biopharma. The Director , CMC Team Leader is responsible for developing ... provide valuable project information and portfolio insights, and we lead CMC due diligence for business development...global R&D project needs . Primary responsibilities of the Director , CMC Team Leader… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Develop meaningful and collaborative relationships with cross-functional teams and leaders. + Lead CMC strategies, assess risks, and develop contingency plans, ... in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is...licensure and right to operate of Gilead's operations. + Lead the execution of these global CMC … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC ... and the respective development stage of the project. The CMC Lead will support the Sr. ...early and late phase drug development candidates within the team to support overall CMC development plan.… more
- Takeda Pharmaceuticals (Boston, MA)
- …to enhancing business processes. As part of the Global Regulatory Affairs CMC team , you will report to the Senior Director Global Regulatory Affairs CMC ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...ensure CMC compliance within the organization. + Lead team members that defines CMC… more
- Lilly (Philadelphia, PA)
- …**Responsibilities:** + Responsible for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions ... people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the...for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for… more
- Actalent (Boston, MA)
- …and agile regulatory professional to join our collaborative team as the Director /Sr. Director of Regulatory CMC . This pivotal role involves providing ... Position: Director /Sr. Director of Regulatory CMC...strategies to support gene therapy development. Key Responsibilities + Lead global Regulatory CMC strategic guidance and… more
- Takeda Pharmaceuticals (Boston, MA)
- …plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team , you will report to the Executive Director and Head, CMC ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team 's success in meeting goals/objectives.… more
- BeiGene (Emeryville, CA)
- We are seeking an exceptional and highly motivated CMC leader to join the BeiGene Cell Therapy team to enable the cell therapy development. Ideal candidate ... programs from a pre-clinical stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions… more
- AbbVie (North Chicago, IL)
- …to questions from regulatory authorities. + Leverage extensive drug development experience to lead the global cross-functional CMC Team in completion of ... and provide drug development experience and advice to the CMC team . Influence development of new regulatory...impact assessment, and implementation of new regulatory requirements. Will lead CMC Coordination activities for later stage… more
- AbbVie (North Chicago, IL)
- … R&D wide or DevSci wide initiatives and strategies Leads a global CMC team of functional representatives from various departments and divisions. Accountable ... aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox...integrates drug substance, drug product, and device inputs to CMC team strategies and plans that align… more
- Gilead Sciences, Inc. (Foster City, CA)
- …relationships with cross-functional teams and leaders across CMC RA and PDM. + Works with CMC RA Team Leads to provide one CMC RA voice to PDM project ... drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and...direct impact. We believe every employee deserves a great leader . People Leaders are the cornerstone to the employee… more
- Lilly (Philadelphia, PA)
- …radiopharmaceutical products working in a fast-paced, multi-disciplinary environment. + Lead multidisciplinary cross functional team (s) to develop, manufacture, ... timelines, quality standards, and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and… more
- Actalent (Boston, MA)
- …communicate regulatory CMC risks and opportunities to both the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies ... Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member...to generate and refine the product development strategy. * Lead preparation of high-quality global clinical trial applications in… more
- Astellas Pharma (Westborough, MA)
- …with local and global stakeholders. **Essential Job Responsibilities:** + Acts as a CMC regulatory lead and/or Deputy for highly complex projects/products and/or ... Do you want to be part of an inclusive team that works to develop innovative therapies for patients?...**Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** +… more
- Frontier Medicines (South San Francisco, CA)
- 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 of CMC...daily pre-formulation/material assessments of API and preclinical formulations + Lead the development of appropriate analytical test methods and… more
- Integra LifeSciences (Plainsboro, NJ)
- …to help improve outcomes. **SUMMARY** Under the direct supervision of the Director , Quality Reliability Microbiology, this individual will have a dotted line ... reporting structure to the local site quality leader . Responsibilities associated with this Sr. Microbiologist include interpreting microbiological testing data,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. **How you will contribute:** + The Senior Director , Pharmaceutical Sciences (PS) Portfolio Leader is accountable for both ... as well as managing & developing a high functioning team of senior PS program leaders that lead.../ R&D and the commercial organizations + The Sr. Director , PS Portfolio Leader is a member… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …immune disorders. **Summary** The Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for ... plan, and budget for project. He/she (or subordinates) will lead cross-functional product decision and manage project team...responsibility to be an interface with R&D as the CMC working group leader of GPT. He/she… more
- Novo Nordisk (Boulder, CO)
- …portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team ). Essential Functions + The successful candidate will build, ... About the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy… more
- Takeda Pharmaceuticals (Boston, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team 's success in meeting goals/objectives on drug-device ... within a project team and properly manage tasks and work expectations, lead , be influential and effective, collaborate with GRA Liaisons, GRA CMC Leads… more