- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Sr. Scientist , Regulatory Affairs CMC will implement regulatory Chemistry, Manufacturing, & Controls ( CMC ) ... Prepare and review of information required for development of Regulatory CMC dossiers for projects and products including clinical development, original… more
- AbbVie (South San Francisco, CA)
- …as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Senior Scientist I role is within a team of highly experienced ... Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long… more
- AbbVie (Boston, MA)
- …various process development functions to ensure technical information is accurately transcribed into regulatory documents. + Lead CMC teams in the development of ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: Support regulatory approval of biologics drug substances by authoring Chemistry,… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description** Gilead Sciences is seeking a talented and highly motivated Senior Scientist to join our Pre-Pivotal Biologics Analytical Operations group. ... into the clinic. The successful candidate is expected to serve as the CMC analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he… more
- AbbVie (Irvine, CA)
- …. Job Description The PDS&T Parenterals/Eye Care group is seeking a motivated Senior Scientist to design innovative formulations and develop robust manufacturing ... microbiology, device engineering, internal and external manufacturing, quality assurance, CMC regulatory affairs, supply chain and Operations Manufacturing… more
- AbbVie (North Chicago, IL)
- …LNPs, Cell Therapy). AbbVie is seeking a highly motivated candidate for the position of Senior Scientist II / Principal Research Scientist I, Biologics Drug ... be an integral part of the product development and CMC teams and will have strong collaborations with several...6+ (PhD) years of relevant industry experience. + For Senior Scientist II: Bachelors, Masters, or PhD… more
- J&J Family of Companies (Malvern, PA)
- …https://www.jnj.com/innovative-medicine We are searching for the best talent for a ** Senior Scientist , Protein Characterization (Forced Degradation Studies)** to ... be in Malvern, PA. **Purpose:** The Senior Scientist will apply an understanding of...and understanding of pharmaceutical development chemistry, manufacturing and controls ( CMC ) processes and regulatory requirements for protein… more
- Merck (Rahway, NJ)
- …Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for a Senior Scientist position available at the Rahway, NJ site. The successful ... to drive late-stage pharmaceutical drug product development and commercialization. The Senior Scientist responsibilities include, but not limited to, analytical… more
- Grifols Shared Services North America, Inc (Durham, NC)
- …products. The role also involves contributing to the Chemistry, Manufacturing, and Controls ( CMC ) section of regulatory submissions. The individual in this role ... Author comprehensive documentation for inclusion in the Chemistry, Manufacturing, and Controls ( CMC ) section of regulatory submissions. 6. Perform detailed data… more
- AbbVie (North Chicago, IL)
- …exciting and rewarding career opportunities for these candidates. Position Description: For the Senior Scientist II position, we are seeking a highly motivated ... is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's...proposals and lead these efforts. Act as a lead scientist in his/her area of expertise and critically evaluate… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …in more than 110 countries and regions. This Senior Associate Research Scientist I position is in the CMC Development, Bioanalytics, Analytical Operations ... personnel at all levels in a team environment. **Minimum Education/Experience Requirements for Senior Associate Research Scientist l:** Degree must be within a… more
- J&J Family of Companies (Malvern, PA)
- …more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for a Senior Scientist , API Upstream Process Development to be located in ... considered. **Purpose:** We are upstream process development group and are hiring a Sr Scientist in our team. In this position you will be contributing to cell… more
- J&J Family of Companies (Malvern, PA)
- …Learn more at https://www.jnj.com/innovative-medicine . Johnson & Johnson is hiring for a ** Senior Scientist , Biotherapeutics** to join our team in Malvern, PA. ... We are the upstream process development group and are hiring a Sr Scientist in our team. In this position you will be contributing to cell culture process… more
- AbbVie (North Chicago, IL)
- …of the supply chain for pipeline molecules and help prepare and defend CMC regulatory content. Chemical/Bio Engineers within Process Engineering support pipeline ... clinical development stages. Process Engineering also partners with Biologics CMC (Chemistry, Manufacturing, and Controls) Development and Aesthetics R&D functions… more
- J&J Family of Companies (Malvern, PA)
- …**We are searching for the best talent for a Principal Scientist , CAR-T Analytical Scientific Integrator - Advanced Therapies to be in ... Malvern, PA.** **Purpose:** The Principal Scientist , CAR-T Analytical Scientific Integrator will provide analytical, technical...in addition to representing Advanced Therapy (BioTD-AD) on the CMC team(s). This role is also responsible for the… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory departments. As a Sr. Process Controls & Validation ... Regeneron is looking for a Sr. Process Controls & Validation Scientist for our Process Controls Development and Lifecycle Management Team. This is a non-lab-oriented… more
- AbbVie (Worcester, MA)
- …new formulation compositions, cost effective manufacturing processes and prepare and defend CMC (Chemistry, Manufacturing and Control) regulatory content. We are ... workflows, manage project timelines and resources. Contribute to development of CMC development path for assigned discovery projects together with clients from… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Drug Metabolism & Pharmacokinetics, Translational Medicine & Clinical Pharmacology, CMC , Regulatory Affairs, Patient Safety and Pharmacovigilance to ... authorities and will consolidate safety data from nonclinical studies into regulatory submissions as needed. In addition, integrated safety assessments may also… more
- Merck (Rahway, NJ)
- …and external manufacturing sites, process validation, and authoring of global regulatory submissions. Additionally, SPD provides our company with deep formulation ... CFD modeling. + Experience in Sterile Drug Product development and CMC development workflows, particularly unit operations such as mixing, filling, pumping,… more
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