- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …that create an inclusive and collaborative work environment. **Brief Job Overview** **The CMC Technical Director ** is a key leadership position within ... and tools to promote engaged, collaborative, and results-driven work environments. **The CMC Technical Director ** has the following responsibilities: *… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and ... Regulatory Functional Excellence - Expertise** + Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Chemistry, Manufacturing and Controls ( CMC ) ... acts as a subject matter expert in various regulatory and technical aspects of small molecule CMC development such as peptides and sterile injectables. + Stays… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at ... inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is responsible… more
- Gilead Sciences, Inc. (Washington, DC)
- …**QUALIFICATIONS** + A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at ... aspirations. Join Gilead and help create possible, together. **Job Description** The Director , CMC Regulatory Affairs Policy, Advisory and Intelligence is part… more
- AbbVie (North Chicago, IL)
- …and strategies. Proposes, supports and implements and influences initiatives across CMC technical functions. Scope: From late-discovery to tech transfer ... high complexity utilizing a matrix approach. Leads Chemistry, Manufacturing and Controls ( CMC ) teams and Product Presentation and Device Strategy Teams (PPDST) of… more
- Takeda Pharmaceuticals (Lexington, MA)
- …provides regulatory CMC input and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and ... This role is within in the R&D GRA Chemistry Manufacturing & Controls ( CMC ) and Devices organization, and will contribute to the team's delivery of critical… more
- Lilly (Indianapolis, IN)
- …and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC technical knowledge and ... development of assigned product(s). Key responsibilities / expectations: + Deep technical knowledge of CMC drug development science(s) + Knowledge of CMC … more
- BeOne Medicines (San Mateo, CA)
- …an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory CMC team based ... China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory submissions and health… 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 team ... CMO. This position develops strategy, prepares content templates and leads technical teams in preparation of submission documents to include clinical trial… 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 ... medicine to patients faster and more efficiently. As a Director -Level Product Owner for in silico CMC ,...skills:** + Proven ability to translate business requirements into technical designs and solutions with a strong financial acumen… more
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director of Chemistry, Manufacturing & Controls ( CMC ) - Quality Assurance ... other market filings, and post approval changes. Partners with technical SMEs to develop and approve the CMC... technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new… 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? ... require work in the office. **Purpose and Scope:** The Director provides strategic leadership, policies, and advanced technical...policies for the Americas. As a member of global CMC teams, this person will lead all aspects of… more
- Boehringer Ingelheim (Ridgefield, CT)
- …that our strength and competitive advantage lie with our people. The Associate Director , US Product CMC Regulatory Affairs is responsible for the coordination ... supplemental applications and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal… 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 the ... to patients faster and more efficiently. As an Associate Director /Senior Manager Product Owner for in silico CMC...user stories. + Coordinate effectively between business stakeholders and technical teams for your product portfolio. + Track and… more
- Atlantic Health System (Pompton Plains, NJ)
- Responsible for a variety of routine and complex technical tasks in the performance of laboratory tests to obtain data for use in the diagnosis and treatment of ... special methods as outlined in the Standard Operation Procedure and/or Technical Manual in resolving difficulties or multiple antibodies, ABO discrepancies,… more
- AbbVie (North Chicago, IL)
- …delivering diligence project objectives. + Stay abreast of developments in global CMC technical , regulatory and compliance arena and industry practice ensuring ... plan, in support of Business Development opportunities. + Responsible for critical technical scientific evaluation of CMC drug substance, drug product, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …influencing and overseeing the Pharm Sci Portfolio Strategy. Able to clearly articulate deep technical CMC development plans and concepts to a wide variety of ... Description** **Objective:** This role serves as the single point of contact for R&D CMC Portfolio Strategy enabling activities on behalf of the CMC community… more
- Lilly (Indianapolis, IN)
- …phase through commercialization. Our scientists and engineers develop innovative technical solutions to advance an existing portfolio that includes small ... experienced and creative candidates with experience in chemistry, manufacturing and control ( CMC ) of oligonucleotides to participate in a wide range of activities.… more
- AbbVie (North Chicago, IL)
- …. Job Description The Operations Science & Technology department supports technical and scientific activities related to the manufacture of pharmaceutical products ... in AbbVie facilities or in contract facilities. The director establishes goals that are consistent with development, manufacturing and customer requirements,… more