- Teva Pharmaceuticals (West Chester, PA)
- Senior Director Regulatory Affairs CMC (Biologic Products) Date: May 15, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible...of submissions for Teva products, and for ensuring the quality of CMC response to global health… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA,...truly global experience that helps cancer patients to improve quality of life . The size of our company ... Proposition: Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive Director ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA ... and right first time. Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to… more
- Editas Medicine (Cambridge, MA)
- …cross-functional teams in the execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible for: + Provide ... future. Position Summary This role will lead and support the CMC strategies and submission including clinical trials applications, marketing applications, agency… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various...on cross-functional Takeda Vaccines teams (commercial, clinical development, delivery, quality , etc.) to ensure that data are identified, obtained… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Associate Director ** **; CMC , Device Development Program Manager** **Functional Area: Technical ... leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and influential role in the… more
- AbbVie (North Chicago, IL)
- …areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan ... global filings. + Responsible for the global filings of high quality CMC dossiers, approvals and commercialization of products. Qualifications *Bachelor's Degree… more
- AbbVie (North Chicago, IL)
- …areas and stays within the approved funding. Accountable for the success and overall CMC quality of a given project. Ensures timely execution of project plan ... ADTAST/ALB and various line functions. Partners with Clinical, Regulatory, Operations, Quality , Preclinical Safety and Commercial Organizations. Apprises CMC … more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... into action and influence policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a… more
- BeiGene (San Mateo, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... and third parties. + Partnering and aligning with Discovery, Regulatory, Operations, Quality , and Clinical functions, and managing CMC -focused deliverables and… more
- AbbVie (North Chicago, IL)
- …or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule ... and scope. + Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall CMC strategies within ... and the respective development stage of the project. The CMC Lead will support the Sr. CMC ...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Lilly (Philadelphia, PA)
- …+ Collaborate with global partners and external vendors to ensure timely and quality delivery of CMC activities. + Drive continuous improvement initiatives to ... and supply novel PET radiopharmaceuticals, ensuring adherence to timelines, quality standards, and cost targets. + Collaborate with cross-functional team… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Principal Scientist/Associate Director , Process Chemistry - CMC , located at our South San Francisco ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...a diverse range of projects simultaneously. + Experience with quality by design (QbD), process validations and statistical design… more
- State of Colorado (Canon City, CO)
- …IV) Mental Health Supervisor - Canon City ( CMC ) Print (https://www.governmentjobs.com/careers/colorado/jobs/newprint/4484249) Apply CDOC (Social Worker/Counselor ... IV) Mental Health Supervisor - Canon City ( CMC ) Salary $6,881.00 - $9,633.00 Monthly Location Canon City,...Board or request a review by the State Personnel Director . An appeal or review must be submitted on… more
- UTMB Health (Huntsville, TX)
- …and methodologies for the division after appropriate discussion with the Pathology Outreach Director . Ensures that quality services are provided to the division. ... Assoc Dir Lab Services - CMC - Estelle **Huntsville, Texas, United States** Clinical...for Correctional Managed Care Laboratory Services. Assists the Medical Director in the overall direction and management of Correctional… more
- UTMB Health (Midway, TX)
- Mental Health Clinician - CMC - Ferguson Unit **Midway, Texas, United States** **New** Social Service UTMB Health Requisition # 2402542 The mission of Correctional ... Works under the supervision of a Psychologist, Mental Health Manager and/or Program Director . **_ESSENTIAL JOB FUNCTIONS_** **:** + Contributes to the success of the… more
- University of Pennsylvania (Philadelphia, PA)
- …academic clinician track requires 100 credits per year of active and high- quality teaching. Clinical responsibilities may include providing clinical care in both ... or concerns about this should be directed to the Executive Director of the Office of Affirmative Action (http://www.upenn.edu/affirm-action/) and Equal Opportunity… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish...time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring … more