- Merck & Co. (North Wales, PA)
- …projects and products that improve human health and business. - Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our ... strategies . - Position Description/Summary: - The CIPM Associate Director , Project Manager , is a core...Provid e mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based… more
- Merck & Co. (Rahway, NJ)
- …Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug Development ... Development pipeline and realize its full potential. The Associate Director is expected to provide project management...- Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …commercialize complex biotherapeutics.The Director of Compliance, reporting to the Senior Director of GMP Operations, will oversee laboratory compliance ... and track internal compliance metrics and report the observed trends to senior management.Provide regulatory support by preparing or reviewing high-quality CMC … more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will ... CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director has responsibility ... of assigned products and projects during lifecycle from development throughout marketing. The GRL CMC Director or Senior Associate Director supports… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their ... CMC areas on the AST serving as spokesperson for the PPDST and CMC project teams and ensures information flow among the AST and all line functions.… more
- Merck (North Wales, PA)
- …projects and products that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was formed to enhance our ... CMC and Clinical strategies. ** ** **Position Description/Summary:** The CIPM Associate Director , Project Manager, is a core member of DCTs, partnering with… 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 ... support future pipeline submissions. + Collaborate with and advise CMC project teams in R&D and Operations...short-term and long-term plans to achieve goals set by senior management. Drive consensus for goals to meet the… 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:** + ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you will oversee the development and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** The Associate Director , CMC Regulatory Affairs for Biologics is responsible for defining ... in accordance with business objectives. + Provide strategic regulatory CMC advice to project teams for biologics...requirements and communicate relevant changes in regulatory information to project teams and senior management in a… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential critical ... CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The project teams will be defined based… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works ... initiatives internal to RA CMC . + Represents CMC regulatory affairs on project initiatives with...position is flexible. Applicants may be considered for the Senior Manager or Associate Director level based… more
- Lilly (Philadelphia, PA)
- …cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory, manufacturing, and supply chain teams, to ensure seamless ... execution of CMC strategies and activities. + Lead and direct the...contribution to the company. + Continuously monitor and track project progress, budget, and resource allocation, and provide regular… more
- AbbVie (Irvine, CA)
- …innovative pipeline of neurotoxins with significant technical complexity. Reporting to the Senior Director of Drug Product Development, the individual will lead ... and coordinating resource demand and capacity to ensure alignment with project goals and priorities. + Coordinate and communicate across multidisciplinary teams… 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 ... implementing procedures, and remediation projects. The candidate must be a senior -level professional/team player with advanced knowledge and experience who thrives… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California._ ** Senior Director - Analytical Regulatory** **Science** **KEY** **RESPONSIBILITIES** ... The Sr Director , Analytical Regulatory Science, is responsible for supervising a... CMC RA Team Leads to provide one CMC RA voice to PDM project teams… more
- Novo Nordisk (Lexington, MA)
- …medical lead of the ATTR cardiomyopathy project . In doing so, the Senior International Medical Director will work across different functional teams to ... the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the… more
- Lilly (Indianapolis, IN)
- …the users' needs and intended uses. **Position Summary:** DDCS is seeking a Senior Director , Packaging Systems to lead, support, and manage container closure ... and delivery device pipeline portfolio. This individual must be versed in CMC development, materials evaluation, and packaging systems design and development to… more
