- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of ... (AST) and ensure the Product Presentation & Device Strategy Team (PPDST) and CMC development plans closely align with the clinical and regulatory development … more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing...budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as… more
- Actalent (Boston, MA)
- …and analytical development strategies. + Identify and clearly communicate regulatory CMC risks and opportunities to both the technical team and Regulatory teams. ... to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams… more
- Boehringer Ingelheim (Ridgefield, CT)
- …products and projects during lifecycle from development throughout marketing. The GRL CMC Director or Senior Associate Director supports complex, ... and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an ... short-term and long-term plans to achieve goals set by senior management. Drive consensus for goals to meet the...and long-range plans. + Identify emerging regulatory trends impacting CMC development and proactively drive best practices… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position makes decisions with consultation. **Responsibilities:** + **Planning for Development :** Manages multiple CMC development projects. ... organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... internal regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principal scientist in support of...success together with risk mitigation measures. + Lead the development , communication, and review of the CMC … more
- Lilly (Indianapolis, IN)
- …The Associate Director , CMC Project Management may also partner with the Senior Director or Assoc. VP, CMC Project Management to deliver high ... global program team/governance and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and implements effective development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently...years) required. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development … more
- Takeda Pharmaceuticals (Boston, MA)
- …part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...oversee the development and execution of regulatory CMC development and registration strategies. RA … more
- Lilly (Philadelphia, PA)
- …requirements applicable to CMC regulatory in applicable geographies + Support CMC development projects as needed from CMC regulatory perspective ... for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for...maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior… more
- Vera Therapeutics (Brisbane, CA)
- …experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for ... and globally to support development programs. The Senior Manager will support both CMC and...communicating regulatory strategies to stakeholders. * Industry experience in CMC development of biologics preferred. * Experience… more
- Charles River Laboratories (Rockville, MD)
- …you build a career that you can feel passionate about. **Role Summary** The Sr . Director Operations leads the development , implementation, and adherence to ... all GMP procedures and policies related to commercial production. The Sr . Director has oversight of Materials Management, MS&T and Manufacturing and is… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Main Purpose and Objectives of Position:** The Sr . Director , Clinical Supply Strategy is accountable for partnering with drug ... development teams, clinical, CMC , and the broader...system (SAP) and communication with key business partners. The Sr . Director provides strategic leadership and technical… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual for a newly created Director / Senior Director role in Process Chemistry in Frontier's South San ... equipment, and scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define...collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Biologics Drug Product MSAT** Gilead Sciences, Inc. is ... Collaborate with CMOs, Quality Control, Quality Assurance, External Manufacturing, Regulatory CMC , Process Development , Supply Chain and other functional areas.… more
- Lilly (Indianapolis, IN)
- …people around the world. Within Lilly Research Laboratories, Synthetic Molecule Design and Development (SMDD) 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
- Boehringer Ingelheim (Duluth, GA)
- …for our employees. As a direct report to the HRD of Animal Health, the Senior Associate Director , HR Operations - AH is instrumental in translating and executing ... Boehringer Ingelheim, you will actively contribute to the discovery, development , and delivery of our products to our patients...Health division, HR COE initiatives, and OPU initiatives. The SR AD, HR Operations - AH is charged with… more