- Sanofi Group (Framingham, MA)
- **Job title** : ** Senior Scientist - CMC Biologics Drug Product Development and Manufacturing - Digital Lead** + Location: Framingham, MA, USA **About ... Development & Manufacturing (BioDPD&M) team as a Senior Scientist and Digital Lead and you...complex instruments. * Interface with our cross-functional partners (including CMC Data Sciences and Research Digital & Biologics Strategy… more
- Lilly (Indianapolis, IN)
- …and evolving global regulatory expectations + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... + Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content + Makes risk-based decisions on… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …This position makes decisions with consultation. **Responsibilities:** + **Planning for Development :** Manages multiple CMC development projects. ... organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- … Senior Associate Research Scientist I/II position is in the CMC Development , Bioanalytics, Analytical Operations Group. The selected candidate will be ... with scientific and non-scientific personnel at all levels in a team environment. ** Senior Associate Research Scientist l:** Degree must be within a relevant… more
- Lilly (Indianapolis, IN)
- …and evolving global regulatory expectations + Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development ... support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ...leadership role in the critical review of molecule specific CMC development strategies and submission content +… more
- AbbVie (Irvine, CA)
- …develops analytical methods for the analysis and characterization of neurotoxin biologics for CMC development . As a member of the Bioassay and Molecular Biology ... and improving the platform methods for our pipeline. The Sr Scientist I / II will be...and their degradation and modification products. + Understanding in CMC development strategy of biologics drugs is… more
- Lilly (Indianapolis, IN)
- …a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content for registration, post-approval ... for people around the world. We are seeking an Advisor/ Senior Advisor for Global Regulatory Affairs CMC ...Trial Applications, Market Registrations And Post-Approval Submissions. The Research Scientist in Global Regulatory Affairs - CMC … 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 ... capabilities to work collaboratively through all phases of CMC development with a primary focus on...South San Francisco has an exciting opportunity for a Senior Scientist I to join a new… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist - Analytical Development (AD) Synthetic Molecules - Early ... . Scientist ) relevant industry experience + Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products… more
- AbbVie (North Chicago, IL)
- …The Product Development Science and Technology (PDS&T) Analytical group is currently seeking a Senior Scientist II to join our team. As a Senior ... to work closely with cross-functional teams including process and product development , CMC , process engineering, internal and external manufacturing, quality… more
- Cambrex High Point (Durham, NC)
- …resource in a related area + Expert in related technologies + Demonstrates continued development in a relevant area of CMC + Working knowledge of advanced ... Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product,… more
- Bristol Myers Squibb (Summit, NJ)
- … of analytical methods in support of solid oral and sterile drug product development and commercialization. The Senior Scientist will facilitate analytical ... for small molecule drug product development activities. **Key Responsibilities** The Senior Scientist will collaborate as an individual contributor or drug… more
- Sanofi Group (Waltham, MA)
- …impact on millions of patients around the world. As an experienced Senior Scientist in the LNP Platform Development Team, you will focus on developing new, ... existing, and executing biophysical characterization methods to support the development of new LNP formulations for the CMC... development of new LNP formulations for the CMC team in the mRNA Center of Excellence with… more
- Eurofins (Indianapolis, IN)
- …+ Takes a proactive role in the critical review of molecule specific GRA- CMC development strategies and submission content. + Makes technical decisions on ... CMC teams to make well-informed decisions + Evaluate regulatory impact on proposed CMC development plans + Communicates effectively verbally and in writing to… more
- Bristol Myers Squibb (Summit, NJ)
- …internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, ... . **Business Unit and Team Summary** Our Drug Product Development team is committed to CMC design,...ingredient (API) in the drug product. The Powder Characterization Scientist / Senior Scientist will be responsible… more
- AbbVie (North Chicago, IL)
- …+ Collaborate with Corporate L&A to ensure the deal model includes appropriate CMC development plans/resources aligned with the Clinical Development Plan, ... development information during the due diligence process. + Establish CMC development strategies, risk assessments, and mitigation plans during diligence,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Research Scientist I, Purification Development - Pre-Pivotal ... help create possible, together. **Job Description** The Senior Research Scientist I, Purification Process Development (Pre-Pivotal) will be responsible for… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, ... . **Business Unit and Team Summary** Our Drug Product Development team is committed to CMC design,...(API) in the drug product. The Form Characterization Principal Scientist / Senior Principal Scientist will be… more
- Amgen (Cambridge, MA)
- …Join us and transform the lives of patients while transforming your career. Process Development Senior Scientist - Analytical Chemist **What you will do** ... 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 (Cambridge, MA)
- … with expertise and some experience in pharmaceutical sciences and drug delivery for a Senior Scientist II position. The primary role of this position is to ... delivery systems (Long-Acting Injectables) for sustained delivery concepts. Qualifications + Senior Scientist II typically requires Bachelors, Masters, or Ph.D.… more