- Merck & Co. (Rahway, NJ)
- …(DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... product.-The specific role will be responsible for advancing the company's biologics portfolio.Correspondingly, the DCT leader will be responsible for delivering… more
- Merck & Co. (Rahway, NJ)
- …procedures, Training, and SOPs for all GxP automation systems.Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand ... Job Description Job Description: The Biologics Process Research & Development organization within our...a key part of our Chemistry, Manufacturing, and Controls ( CMC ) hub at our site headquarters in Rahway, NJ.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2026. This full-time position works for approximately 37.5 hours per week.Responsibilities:As CMC Technology Management, we support every step of CMC strategy, ... the department and provide beneficial experience and understanding of CMC principles, strategies, and processes: Understand regulatory compliance/requirements of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Janssen. This effort will extend to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the ... and commercial support. The Quality Compliance scope includes working on Quality related sub-teams such as change control sub-teams and investigational… more
- Parexel (Montgomery, AL)
- …and post-approval changes Cross-Functional Collaboration - Partner with manufacturing, quality , and external organizations to address CMC -related issues ... highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's… more
- Teva Pharmaceuticals (West Chester, PA)
- CMC Biologics Quality Control Director, Physiochemical Testing Date: Nov 15, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: ... CMC organization Design, plan, organize, analyze, and evaluate key elements of Biologics CMC QC strategy Specialized Knowledge: LIMS, TrackWise or VEEVA … more
- Merck (West Point, PA)
- …(DCT) leader is accountable for delivering a fully integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial ... product. The specific role will be responsible for advancing the company's biologics portfolio. Correspondingly, the DCT leader will be responsible for delivering… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Recruit and hire new talent. + Accountable for: + Defining critical quality attributes (CQAs) across the late-phase biologics portfolio and building deep ... across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality , Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical… more
- AbbVie (North Chicago, IL)
- …transfer. + Experience in managing third party manufacturers. + Experience with quality risk management and drug product control strategies. Additional ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Biologics Drug Product Development (Bio DPD), a part of Development… more
- Genentech (South San Francisco, CA)
- …related discipline. + 15+ years of experience in the bio-pharmaceutical industry, ie biologics manufacturing, development or related CMC functions, with at least ... **The Position** The PTD Global Biologics organization plays a pivotal role in the...DS/DP Process Equipment, Analytical Instrumentation for Process Monitoring and Control , AI applications, and Process Modeling. The role also… more
- Parexel (Providence, RI)
- …and post-approval changes Cross-Functional Collaboration * Partner with manufacturing, quality , and external organizations to address CMC -related issues ... highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's… more
- Astellas Pharma (Northbrook, IL)
- … Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for new products), ... are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Regulatory Submission support for US FDA and other Health Authorities. + Ensures all Quality by Design (QbD) and Design Control activities related to drug ... support of company clinical trials. + Collaborates with other external functions on CMC matters (eg, Quality , Commercial, Regulatory Affairs, etc.). Ensures the … more
- Taiho Oncology (Princeton, NJ)
- …scientific expertise in a discipline related to pharmaceutical development, manufacturing, or quality . + Fifteen years' previous CMC drug development and ... related area. + Substantial experience leading and preparing Chemistry, Manufacturing and Control ( CMC ) documentation for regulatory filings. + Experience in… more
- Boehringer Ingelheim (Duluth, GA)
- …alignment with corporate goals. + Defines, plans, and oversees the development of high- quality CMC regulatory submissions, with a focus on securing timely ... with Quality , R&D and Operations/Manufacturing. The Director, Scientific Expert CMC provides subject matter expertise in functional areas related to, and driven… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description AbbVie Biologics Analytical Research & Development ( Biologics ARD) is a ... global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic products. Our scope… more
- Amgen (Thousand Oaks, CA)
- …patients while transforming your career. **Process Development Senior Scientist - Pivotal Biologics Drug Substance Technology** **What you will do** Let's do this. ... at Amgen develops, characterizes and supports the commercialization of biologics drug substance manufacturing processes for all late-stage programs across… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Key Responsibilities** Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply of Gilead's clinical and commercial ... Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. This role requires collaboration at… more
- AbbVie (South San Francisco, CA)
- …through innovative solutions. We are responsible for all Chemistry, Manufacturing, and Control ( CMC ) analytical activities related to the development of AbbVie's ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description 2026 Biologics Analytical Research & Development Intern Overview Envision spending your… more
- AbbVie (North Chicago, IL)
- …through innovative solutions. We are responsible for all Chemistry, Manufacturing, and Control ( CMC ) analytical activities related to the development of AbbVie's ... specialized protein separation techniques to enable the analysis of product quality attributes of interest. + Troubleshoot equipment and experimental problems. +… more
