- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives. **Responsibilities:** +… more
- AbbVie (North Chicago, IL)
- …LinkedIn. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with internal and external partners to ... understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …biological developmental projects with supervision, including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ... (RA) CMC project representative to the CMC sub...biological developmental projects with supervision, including working with contract manufacturing organizations CMO.** This position develops strategy, prepares content… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Program Manager / Senior Program Manager , CMC Portfolio Management will ... 2+ years of work experience in same disciplines. + Senior Program Manager + Bachelor's degree required...cross-functional teams + Experience within the Small Molecule Chemistry, Manufacturing , and Control ( CMC ) drug development space… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to secure and ... in coordination with key internal stakeholders. This position will manage regulatory CMC aspects of compounds (large molecules) through all phases of development,… more
- Astellas Pharma (Westborough, MA)
- **Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies for ... work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data… more
- Kelly Services (Vancouver, WA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager opportunity with a generative AI biotechnology company in Vancouver, WA. If you're passionate about ... Experts. **Workplace:** Onsite in Vancouver, WA **Salary:** $95,000-130,000 **Overview** Drive CMC development, scale-up, cGMP manufacturing , and quality control… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist, CMC Digital Product Development, CMC Digital Product ... team to help digitize our process development, analytical development, and manufacturing workflows and enable cross-functional access to data. You will be… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...pipeline. Your responsibilities will include driving the development and manufacturing of drug substances, overseeing both internal and external… more
- Integra LifeSciences (Plainsboro, NJ)
- …Laboratories, Microbiology, and Sterility Assurance department and working with the ** CMC Plainsboro, NJ** Integra manufacturing site. Qualified candidates must ... monitoring, and maintaining the sterility assurance used in medical device manufacturing . The candidate must have experience interpreting and applying standards and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports ... supply of Gilead's clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network,… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist - Analytical Development (AD) Synthetic Molecules - Early Development where ... of expertise. + Develop and leverage strategic understanding of project and CMC priorities to plan/coordinate with cross-functional peers and evaluate impact of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …therapies to patients worldwide. **How you will contribute:** + The Senior Director, Pharmaceutical Sciences (PS) Portfolio Leader is accountable for both ... as managing & developing a high functioning team of senior PS program leaders that lead a significant portion...is accountable for delivering Excellence in leadership, Excellence in CMC Strategic Development, and the implementation of playing to… more
- Integra LifeSciences (Plainsboro, NJ)
- …RECEIVED** Under the supervision of the Plant Manager of the CMC Plainsboro, NJ site. **SUPERVISION EXERCISED** Manufacturing and Training **ESSENTIAL DUTIES ... the overall manufacturing operations for Integra's Collagen Manufacturing Center ( CMC ), working within FDA medical...to challenge status quo **INTEGRA LEADERSHIP CAPABILITIES** As a senior leadership position in the company, the role is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager : Strategic Sourcing and Supplier Management, Devices** Gilead ... worldwide, with headquarters in Foster City, California. **KEY RESPONSIBILITIES:** The Senior Manager , Strategic Sourcing & Supplier Management, Devices owns… more
- Integra LifeSciences (Plainsboro, NJ)
- …( CMC ) in Plainsboro, NJ. Reporting to the assigned value stream manufacturing manager , this position is responsible for leading cross-functional teams in ... of us are challenging what's possible and making headway to help improve outcomes. The ** Senior Project Manager ** is a key member of the value stream leadership… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- QC Stability, Senior Manager - Monroe, NC Department: Chemistry Location: Monroe, NC START YOUR APPLICATION ... execute, and manage the stability program in support of all sterile manufacturing -s (prefilled syringes/vials). Ensure program is in alignment with FDA, ICH, WHO… more
- Sumitomo Pharma (Columbus, OH)
- …a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Financial Planning & Analysis,** supporting our Technology and ... as financial advisor to the T&Q organization, including VPs in Manufacturing , Quality, Supply Chain, CMC , and CPC, as it relates to Operating Expense Management.… more
- University of Miami (Miami, FL)
- …Miami Miller School of Medicine is actively seeking a dedicated Quality Assurance Manager to oversee the quality control and assurance of all clinical trials within ... Reporting to the Executive Director of the Clinical Research Cellular Therapy Manufacturing Program (CRCMP), this full-time position is critical in supporting the… more
- Amazon (North Reading, MA)
- Description We are seeking a Senior Manager for our functional safety engineering development team. In this role, it will be your job to help drive engineering ... yet rapidly expanding team. This position reports directly to the Sr Manager of Regulatory Compliance. Key job responsibilities * Applying IEC industrial standards… more