- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.Essential ResponsibilitiesServe as lead scientist on assay development, validation, and sample analysis project Follow GMP ... in a supervisor role and leading teams Knowledge and application of regulatory guidance to experimental planning and design Preferred experience working in GMP… more
- Merck & Co. (Rahway, NJ)
- …Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory , Quality, and Commercial-facing Partner Groups to ... Job DescriptionPrincipal Scientist , Late Stage Analytical Program LeadAbout the roleYou...knowledge and life-cycle management of the program to support regulatory filings.Required Experience and Skills:Extensive experience in analysis of… more
- AbbVie (South San Francisco, CA)
- …as bi-specifics and novel modalities, to human clinical studies and eventual licensure. This Principal Scientist I role is within a team of highly experienced ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and… more
- Sanofi Group (Cambridge, MA)
- …Sanofi is seeking a highly motivated individual to join our analytical group as a principal scientist . The group is part of the synthetic platform within Global ... + Ensure good communication and cooperation among different functional groups, including CMC Dossier, Regulatory CMC , Research Platform, and Manufacturing… more
- Merck (West Point, PA)
- **Job Description** ** Principal Scientist , Sterile Drug Product Commercialization** As part of Our Company's Manufacturing Division, the Sterile Drug Product ... products and combination products. We are seeking an experienced Principal Scientist to advance and commercialize a...demonstration and qualification (PPQ) and shelf-life strategies. + Influence CMC regulatory strategy and author DP … more
- Merck (West Point, PA)
- **Job Description** **Position Description:** **Associate Principal Scientist , Sterile Drug Product Commercialization** As part of Our Company's Manufacturing ... pharmaceutical products and combination products. We are seeking an experienced Associate Principal Scientist to advance and commercialize a biologics pipeline… more
- AbbVie (North Chicago, IL)
- …for the chemical development of AbbVie's clinical candidates. We are seeking a Principal Research Scientist II to conduct process research and development of ... laboratory data, technical memos and reports. + Collaborate to ensure successful CMC interactions with regulatory authorities. + The position involves… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …every treatment we pioneer. Join us and make a difference. Position Summary The Principal Process Engineer/ Scientist acts as a technology transfer lead in the ... cGMPs, BMS procedures, and that processes are defined consistent with regulatory filings. This position must comply with all Security guidelines, Environmental… more
- Amgen (Thousand Oaks, CA)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Principal Scientist ** **Live** **What you will do** Let's do this! Let's change the ... sites + Author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. Answer analytical and product… more
- Amgen (Thousand Oaks, CA)
- …patients worldwide. It's time for a career you can be proud of. Process Development Principal Scientist **Live** **What you will do** Let's do this. Let's change ... sites + Author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. Answer analytical and product… more
- Merck (Rahway, NJ)
- **Job Description** ** Principal Scientist , Late Stage Analytical Program Lead** **About the role** You will join our Large Molecule Analytical Validation team to ... Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory , Quality, and Commercial-facing Partner Groups to… more
- AbbVie (North Chicago, IL)
- …worldwide and markets medicines in more than 170 countries. AbbVie is seeking a Principal Research Scientist I to conduct process research and development of ... early clinical phases. Key Responsibilities: + We seek a highly motivated scientist , with a proven track record of accomplishment in the biopharmaceutical industry,… more
- AbbVie (Irvine, CA)
- …Aesthetics on LinkedIn. The Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director/Senior Principal Research Scientist ... productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from early-stage… more
- AbbVie (North Chicago, IL)
- …ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic ... The candidate will serve as analytical lead on internal CMC teams and will work with external parties on...data packages that drive product and process understanding, and regulatory submission content. Major Responsibilities: + As analytical lead,… more
- AbbVie (Irvine, CA)
- …mix; leading discussions, asking the right questions, and driving results. The Principal Research Scientist is responsible for supporting the development, ... generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products. The individual… more
- Merck (West Point, PA)
- …Supply Manufacturing. We are seeking an innovative, highly motivated, and broadly experienced Principal Scientist to join us at our research and development site ... and leading technical development teams + Experience with authoring and reviewing CMC regulatory documentation The successful candidate will be expected to… more
- AbbVie (North Chicago, IL)
- …and global interfaces across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), Quality Assurance (QA), CMC ... functional vision into actionable strategies. + Stays current on global regulatory expectations and trends (via guidelines, GMPs, trade organizations, and other… 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
- Pfizer (Groton, CT)
- …with other Pharm Sci partner lines (eg Analytical R&D, Chemical R&D, Global CMC , Pharm Sci Operations, Drug Product Supply, Quality Assurance) and other lines ... development strategies** + **Authors and provides guidance to authors of regulatory documents supporting drug product development, including relevant drug product… more
- Cambrex High Point (Durham, NC)
- …chemistry affecting analytical technique + Ability to help identify risks for regulatory compliance or violation of site SOP + Participates in experimental design, ... and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness and accuracy +… more
