- AbbVie (North Chicago, IL)
- …5-10 years of working experience required in the same/similar role or in related CMC function. + Multiple product development experiences of leading a ... participates in communications and meetings with regulatory agencies. Accountable for creating CMC development plan incl. timelines, risks and mitigations in… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Product Owner ( Director ) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About the Job** At Sanofi, we're ... faster and more efficiently. As a Director -Level Product Owner for in silico CMC , you...company is a strong plus + Knowledge of software development in a GxP environment is a strong plus… more
- Lilly (Indianapolis, IN)
- …Demonstrated scientific knowledge in drug development including API, or Drug Product or Analytical + Demonstrated CMC regulatory experience Lilly is ... better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC ...Ensures appropriate definition and approves regulatory strategies for global CMC development and manufacturing changes. + Maintains… more
- AbbVie (North Chicago, IL)
- …& Development (R&D) organizations. Represents CMC on teams such as product development , Global Regulatory Product Teams and Operations brand teams to ... requests. + Represents CMC regulatory affairs on teams such as the product development , Global Regulatory Product Teams and Operations brand teams,… more
- Takeda Pharmaceuticals (Lexington, MA)
- … CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead. Assigned products include genetically ... Accountabilities: + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy. + Combines extensive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible ... multiple products. + Lead the execution and influence the development of global CMC regulatory strategies, including...risk mitigation strategies to ensure right first-time approvals of product submissions. + Lead the execution of these global… more
- Lilly (Indianapolis, IN)
- …and evolving global regulatory expectations + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content + Makes risk-based decisions on… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …commercialization planning), pharmaceutical sector planning/ development , product development , and technology transfer. The Technical Director will lead ... inclusive and collaborative work environment. **Brief Job Overview** **The CMC Technical Director ** is a key leadership...responsible for the development and implementation of CMC and product supply technical assistance activities… more
- Bristol Myers Squibb (Indianapolis, IN)
- …analytical) strategies for CMC activities (drug substance, API, drug product , and analytics) for compounds in Development (radiopharmaceuticals). The ... be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC )...following. Other duties may be assigned. + Member of CMC Development Teams providing Quality (QA) input… more
- BeOne Medicines (San Mateo, CA)
- …of relevant pharmaceutical or biopharmaceutical industry experience in innovative drug CMC development , manufacturing, Quality, etc. including minimum 8 years ... team in US. * Lead or/and oversee the development and implementation of biologics regulatory CMC ...or/and oversee regulatory risk assessment, identify key biologics regulatory CMC issues and mitigation activities needed throughout product… more
- Boehringer Ingelheim (Ridgefield, CT)
- …We realize that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory...DMF Annual Report on behalf of the DMF Holder. CMC Development : + Provides US CMC… more
- Astellas Pharma (Northbrook, IL)
- ** Director CMC Development PRTL Packaging & Device US** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? ... and develop strategies for compliance. + Directs and maintains Device/Combination product development strategy following current regulations for product… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Digital Product Owner (Associate Director /Senior Manager) In Silico CMC **Location:** Cambridge, MA, Framingham, MA or Morristown NJ **About ... more efficiently. As an Associate Director /Senior Manager Product Owner for in silico CMC , you...company is a strong plus + Knowledge of software development for chemistry applications is a plus **Key skills:**… more
- Merck (Rahway, NJ)
- **Job Description** This position is an individual contributor role in the GRACS Regulatory CMC and Quality Team. The primary role for this position is to act as ... Lead System Owner of the Medical Device and Combination Product (MDCP) Design Controls IT solution JANUS with Quality...and transactional data. With direction and guidance from the Director Quality Systems & Compliance, this role is responsible… more
- Atlantic Health System (Pompton Plains, NJ)
- …or hemolyzed blood according to approved procedures + Monitors blood and blood product inventory to ensure adequate supply for patient transfusion, orders blood and ... cost. This commitment is also echoed in the respect, development and opportunities we give to our more than...members. Offerings vary based on role level (Team Member, Director , Executive). Below is a general summary, with role-specific… more
- AbbVie (North Chicago, IL)
- …+ For executed deals, coordinate with Development Sciences leadership to identify Product Development Director , and drive the knowledge transfer process ... to translate a clinical development plan into a phase appropriate CMC product development strategy and executable plans. Key Stakeholders: VP … more
- Gilead Sciences, Inc. (Foster City, CA)
- …manufacturing, or supply chain, or quality, or CMC regulatory, or process development , or as part of a cross-functional product team in the broader ... than 35 countries worldwide, with headquarters in Foster City, California. **Senior Director , PDM Product Strategy Leader** **Foster City, CA** **KEY… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …and provide project teams with the strategic regulatory guidance to expedite product development , registration and through lifecycle management. + Responsible ... team and provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC ...and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic… more
- Lilly (Indianapolis, IN)
- … cycle (proof of concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is expected + ... purification, isolation, and formulation. The position presents an opportunity to lead CMC activities to support clinical trials, product commercialization, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …incorporated + High throughput analytical testing for drug substance and drug product development , including setting up robust business processes and automation ... aspirations. Join Gilead and help create possible, together. **Job Description** The Director in Biologics Analytical Development (Pivotal and Commercial) will… more