- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …presented in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics ... Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Catalent (St. Petersburg, FL)
- Scientist II, Analytical Research & DevelopmentPosition SummaryCatalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... and analytical services to solve difficult development and manufacturing challenges.The Scientist II, Analytical Research & Development will independently test Raw… more
- Insmed Incorporated (San Diego, CA)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewInsmed is seeking a Scientist , QC with broad knowledge and expertise in cell-based potency assays, ... assays as applied to AAV gene therapy products. The scientist will be involved in transfer of method from...reportsMay act as an analytical lab representative on a CMC team.Perform quality management activities such as deviation, CAPA,… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the ... laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early… more
- Lundbeck (Bothell, WA)
- …Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has ... Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs) Collaborate with QC to ensure… more
- AbbVie (South San Francisco, CA)
- …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 ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...to human clinical studies and eventual licensure. This Principal Scientist I role is within a team of highly… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Senior Research Scientist I, Cell Culture Process Development - Pre-Pivotal Biologics CMC ... and help create possible, together. **Job Description** The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) will be responsible for… more
- Amgen (Cambridge, MA)
- …It's time for a career you can be proud of. Process Development Senior Principal Scientist - CMC Team Lead **Live** **What you will do** Let's do this. ... within the analytical sciences space. + Author chemistry, manufacturing and controls ( CMC ) sections in regulatory files, lead the preparation of responses to… more
- AbbVie (South San Francisco, CA)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Development Sciences Biologics CMC Drug Substance Cell Line Development Group in South San Francisco, ... CA is seeking a Scientist to join a talented and collaborative team developing...talented and collaborative team developing CHO cell lines for GMP applications. In this laboratory position, the candidate will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in a manner that facilitates Health Authority reviews. - Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics ... Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Amgen (Cambridge, MA)
- …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 world! In ... phase synthetic small molecule, synthetic peptide, and/or siRNA programs. The Scientist will integrate and optimally utilize platform and in-depth product attribute… more
- AbbVie (Irvine, CA)
- …biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist position based in Irvine, CA. The scientist will apply scientific, ... reduce cost and/or enhance the intellectual property landscape. + Support CMC life cycle management and post-approval continued process validation for commercial… more
- AbbVie (Irvine, CA)
- …biological toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist II position based in Irvine, CA. The scientist will apply ... reduce cost and/or enhance the intellectual property landscape. + Support CMC life cycle management and post-approval continued process validation for commercial… more
- Randstad US (Social Circle, GA)
- …Customer: Analytical Development, Process Development, Manufacturing, Supply Chain. skills: CMC , Chromatography, GMP (Good Manufacturing Practice) Equal ... usa - scientist . + social circle , georgia + posted...Team leadership + Experience with analytical method validation and/or GMP investigations + Direct experience in authoring and review… more
- Amgen (Thousand Oaks, CA)
- …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 world! In ... + Author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. Answer analytical and product quality… more
- AbbVie (South San Francisco, CA)
- …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 ... South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of...modalities, to human clinical studies and eventual licensure. This Scientist I role is within a team of highly… more
- Amgen (Thousand Oaks, CA)
- …other innovative, driven professionals in this meaningful role. **Process Development Senior Scientist - Analytical Chemist** **Live** **What you will do** Let's do ... this! Let's change the world! Amgen is currently seeking a Sr. Scientist - Analytical Chemist in our Pivotal Attribute Sciences Department in Thousand Oaks, CA. This… more
- Lundbeck (Bothell, WA)
- Senior Scientist , Potency Assays Requisition ID: 5273 Location: Bothell, Washington, US Do you want to join a team where the mission is meaningful, the challenges ... Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Scientist II, Analytical Research & Development** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the ... analytical services to solve difficult development and manufacturing challenges. The ** Scientist II, Analytical Research & Development** will independently test Raw… more
- Kelly Services (Frederick, MD)
- **Process Validation Scientist ** + Demonstrate specific upstream cell culture and downstream purification unit operations knowledge in support of bioprocessing of ... protocols/reports review/approval timely generation of Chemistry Manufacturing and Controls ( CMC ) documentation + Collaboration between Manufacturing Sciences and Technology… more
