- Takeda Pharmaceuticals (Cambridge, MA)
- …innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a ... Senior Manager of Statistics, you will provide statistical leadership in...design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …standards. Lead responses to Health Authority questions and deficiency letters. + Represents CMC RA in project team meetings and provides expert interpretation ... of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality,… more
- BeOne Medicines (Emeryville, CA)
- …implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high-quality global ... throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development...product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …approaches to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + ... Description** **About the role** Join us as our **Global Manufacturing Sciences CMC Lead** and drive **high-impact, high-visibility CMC projects for innovative… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Title: Senior Manager , Commercial Biologics Product Science Lead** **Location: Lexington, MA ... biologics portfolio. In this role, you will be a senior subject matter expert across one or more products...timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely… more
- BeOne Medicines (Emeryville, CA)
- …commercial negotiations, defining responsibilities between BeiGene and the CMO. Act as project manager of the contract negotiation with close partnership with ... **General Description:** The Senior Procurement Manager of CMO Category...with contract manufacturers (CMOs) worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC … more
- Bausch + Lomb (Tampa, FL)
- …continue leading the advancement of eye health in the future. **Objectives/Purpose of Job:** The Senior Manager is a member of the Pharma and Lens Care Solutions ... Plastics and Packaging Engineering Team within the Pharmaceuticals/Consumer business vertical. The Senior Manager leads a team of Primary and Secondary Packaging… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... of regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating… more
- Amgen (Thousand Oaks, CA)
- …and transform the lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this. Let's change the ... Amgen's Commercial Attribute Sciences group in Thousand Oaks, California is seeking a Senior Scientist. The successful candidate will join us on our effort to… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Takeda Pharmaceuticals (Boston, MA)
- …into issues and develops contingency plans; communicates timely and proactively project -related issues to senior executive management and manages issues ... and empower you to shine? Join us as a Senior Director, Global Program Leader - Oncology, Solid Tumors...through the functional sub-teams leaders and their teams all project deliverables achieve defined project scope &… more
- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director, Project Management** in our **Non-Interventional Oversight Team… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as a ... 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location:… more
- Stantec (Sacramento, CA)
- …and industry experience to consistently produce project deliverables that meet project requirements and the project manager and client's expectations. ... plumbing. Your Key Responsibilities - With direction from a project manager and/or Professional Engineer Design, develop,...as part of a coordinated design team. - Assist senior engineers in the design and development of mechanical… more
- Boehringer Ingelheim (Duluth, GA)
- …strategic and operational initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving current processes and ... leader by reflecting the regulatory submission timing needed for project program. + Fosters strong collaboration with RA team...The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership… more
- WSP USA (Milwaukee, WI)
- WSP is initiating a search for a Senior Field P&C Engineer. **This Opportunity** At WSP we strive to create an environment where our field teams operate safely, ... please send us your resume. This position reports to the Midwest Region Department Manager or Area Lead. Under the guidance of an experienced Field Engineer or… more
- WSP USA (Boise, ID)
- WSP is seeking a ** Senior Field P&C Engineer** to work from our **Boise, ID** office. At WSP we strive to create an environment where our field teams operate safely, ... your resume. **This Opportunity** This position reports to the Midwest Region Department Manager or Area Lead. Under the guidance of an experienced Field Engineer or… more
- Bristol Myers Squibb (Princeton, NJ)
- …experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and ... key internal stakeholders and outside of BMS (functional and project leaders, peers and employees at all levels, vendors,...+ US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …day and improving the lives of patients for generations to come. As a Senior Research Associate at Gilead you will + Plan and successfully execute experiments and ... working environment, and continuous improvement + Help support key project or department stakeholders as needed to ensure that...as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and… more
- Bristol Myers Squibb (Seattle, WA)
- …commercial products. This role is responsible for developing and executing the CMC strategy for assigned products, managing key technical risks, and ensuring ... technical alignment with stakeholders. As a key member of the CMC and Global Operations (GO) Team, they will support to deliver on aligned brand strategy and Global… more
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