- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where ... trade associations and acts as an advisor/ liaison to senior management to plan, evaluate and recommend implementation strategy....CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -… 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 ... projects while also supervising and mentoring a team of CMC Product Development Directors. A key function of the...the Product Presentation & Device Strategy Team (PPDST) and CMC development plans closely align with the clinical and… 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 ... experienced team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting to the VP CMC … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type… more
- Merck (North Wales, PA)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product franchises in accordance with domestic… 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 ... life better for people around the world. **Position Summary:** The Associate Director , CMC Project Management will provide strategic and operational leadership… more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... to bring life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and lead the execution of… 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:** + ... to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you will oversee the development and execution… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; ... leads meetings with Health Authorities under supervision of a senior member of the department. + Reviews CMC... senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC ... + Develop and maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior leadership + Review… 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 ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… 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...budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as… 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 ... Job Title: Senior Manager, Regulatory CMC Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on… 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...incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director ) OBJECTIVES/PURPOSE + To define and implement anexternal ... and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend CMC... senior management to plan, evaluate and recommend CMC Module 3/Module 2 submissions with intent to streamline… more
- Lilly (Indianapolis, IN)
- …product, process validation, process controls, compliance, continuous process optimization, CMC regulatory support, manufacturing data analysis and process data ... management. The Sr. Director - TS/MS enables operational excellence by establishing strong...arise as part of routine manufacturing. + Collaborating with CMC to define, implement and improve control strategies for… more
- Novo Nordisk (Lexington, MA)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the ... you ready to make a difference? The Position The Senior International Medical Director serves as a...Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… 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
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... (including but not limited to clinical Operation, Quality, Regulatory, CMC , and GRDS) to ensure alignment of organizations and...mitigation plans by working with supply chain leaders and CMC project managers. + Act as point of escalation… more