- Novo Nordisk (Boulder, CO)
- …Reports into Director , CMC Program Development. Essential Functions + Project Management + Lead programs, or series of related projects spanning multiple ... 5+ years of relevant working experience required. + 2+ years of proven project management experience + Experience in pharmaceutical or biotech environment +… more
- Lilly (Indianapolis, IN)
- …with CMC and device team members, program teams and functional leads. + Provide CMC Project Management for both internal and external CMC development ... preferably in a scientific discipline. **Additional Skills:** + Experience with project management tools. + Strong communication, leadership, and collaboration… more
- Taiho Oncology (Pleasanton, CA)
- Director , Regulatory Affairs CMC Pleasanton, CA,...the ability to lead others. + Working knowledge of project management . The pay range for this ... and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly...activities of external consultants in consultation with Global Executive Director or designee. + Prepare project and/or… 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 ... Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals....across a very complex matrix environment in GRA with CMC RA project leads and other GRA… more
- Editas Medicine (Cambridge, MA)
- …keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed of developments opportunities and ... execution of these submissions. Key Responsibilities: + As the Director , Regulatory CMC , you will be responsible... focus health authority meetings. + Accountable for the management and delivery of all CMC regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …priorities simultaneously. preferred - 4 or More Years Extensive experience in project management , process, product, and/or analytical development activities and ... CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project ...to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess … more
- Takeda Pharmaceuticals (Boston, MA)
- …Participate in and/or lead agency meetings on CMC topics. + Ensure project team colleagues, line management , and key stakeholders are apprised of risks ... life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you...development + May serve as direct/matrix manager of RAV CMC staff, depending on project . Responsible for… more
- AbbVie (North Chicago, IL)
- …+ Represents all CMC areas on the AST serving as spokesperson for the CMC project team and ensures information flow among the AST and all line functions. ... the approved funding. Accountable for the success and overall CMC quality of a given project . Ensures...develops agendas, issues highlights, apprise risks and plans with CMC Management , conduct periodic reviews, to ensure… more
- Lilly (Indianapolis, IN)
- …bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and ... Lilly is looking for regulatory Chemistry, Manufacturing and Control ( CMC ) scientists to join us in developing and bringing...group to support global submissions and registrations. As the project leader, you will be expected to collaborate with… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …recruiting, industry, or related fields. + Strong communication, presentation, writing, and project management skills. + Detail oriented. + Ability to work ... (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center...MiM student cohort. + Collaborate with employer relations and CMC team to facilitate seamless implementation of in-person and… more
- Frontier Medicines (Boston, MA)
- …years of experience in small molecule drug substances and drug products + Project Management experience considered advantageous + Proven ability to work ... 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… more
- Bausch Health (Petaluma, CA)
- …+ Should have good working knowledge of all areas of development - including CMC , non-clinical, clinical, project management and regulatory functions + Will ... product ideas and thoroughly research it with medical, clinical, CMC , IP and Key Medical Expert as needed +...above a minimum of 5 year of experience in project management , leading multi-disciplinary project … 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...across a very complex matrix environment in GRA with CMC RA project leads and other GRA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …manner that facilitates Health Authority reviews. - Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and ... determines filing strategies, provides expertise as regulatory CMC representative to project teams, and supports change implementation. Coordinates with… more
- Gilead Sciences, Inc. (Foster City, CA)
- … RA and PDM. + Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. ... 35 countries worldwide, with headquarters in Foster City, California._ **Senior Director - Analytical Regulatory Science** KEY RESPONSIBILITIES The Sr Director… more
- AbbVie (North Chicago, IL)
- …policies and government regulations. + Ensures adequate support of multiple assigned CMC projects and contributes to project prioritization on a portfolio ... to deliver high-quality drug products for patients. The Director , Biologics ARD will lead the Analytical Development-Early Phase...level. + Proactively supports Biologics CMC Development Management of plans and risks… more
- CSL Behring (King Of Prussia, PA)
- …methodologies. This role requires a combination of drug development knowledge, project management expertise, and excellent facilitation and communication skills. ... PA office. It is a Hybrid role. The Associate Director , R&D Project Planning Capability Lead, is...fostering a culture of continuous learning and improvement.** **Evaluate project management tools and techniques to support… more
- Pfizer (Groton, CT)
- …work in an environment where you can:** + Have overall responsibility for the project management of the analytical activities and associated strategy in the ... early phases of development to commercial launch. As a Director in the group you will lead a team...improvement initiatives as required to ensure best in class project management + To champion novel ways… more
- Sumitomo Pharma (Columbus, OH)
- … of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and reviewing ... **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA)...**Job Duties and Responsibilities** + Represent QC on cross-functional project teams. + Provide quality management oversight… more
- Merck (Boston, MA)
- …preferred. **Required Experience and Skills:** + At least 6 years of experience in project management . + At least 3 years of experience in planning, scheduling, ... as well as supply chain documentation to support critical CMC activities. + Support the collection of clinical supply...and organizations. + Strong knowledge of the principles of project management and clinical customer relationship … more