- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential ... **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead . In case no Sr CMC … more
- Sanofi Group (Waltham, MA)
- **Job Title:** CMC Drug Substance Senior Development Leader - Late Stage- Vaccines **Location** : Waltham, MA **About the Job** As part of the Global Drug ... role you are expected to work independently and to lead a cross-functional DS CMC Sub-team with...aligned risk mitigation plans and its implementation with the CMC core team. + Collaborate with Analytical … more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of ... leadership on key pipeline projects while also supervising and mentoring a team of CMC Product Development Directors. A key function of the role is to serve as… more
- Lilly (Indianapolis, IN)
- …The anticipated wage for this position is $121,500 - $178,200 We are seeking an Advisor/ Senior Advisor for Global Regulatory Affairs CMC to be a part of the ... the Project Leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical and operational support for Clinical Trial… more
- Takeda Pharmaceuticals (Boston, MA)
- …all major countries + Develop, implement and execute a smart sourcing strategy + Lead global CMC key initiatives and represent Pharmaceutical Science to other ... at least 10 years relevant industry experience including significant experience in analytical science, cGMP compliance, CMC regulatory requirements in multiple … more
- AbbVie (North Chicago, IL)
- …development of programs with outsourced analytical activities. The candidate will serve as analytical lead on internal CMC teams and will work with ... ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …relevant industry experience + Minimum of 10 years of experience working in CMC analytical development area for active pharmaceutical ingredients and drug ... and scientists and their teams in the field of analytical controls and compliance + Global CMC ... staff and global line and function heads + Lead global CMC and Quality key initiatives… more
- AbbVie (Irvine, CA)
- …asking the right questions, and driving results. Our department develops analytical methods for the analysis and characterization of neurotoxin biologics for ... CMC development. As a member of the Bioassay and Molecular...and improving the platform methods for our pipeline. The Sr Scientist I / II will be a technical … more
- Amgen (Cambridge, MA)
- …labs + Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. + ... lives of patients while transforming your career. Process Development Sr Scientist **What you will do** Let's do this....role you will work closely with a team of analytical chemists, organic chemists, and formulation scientists responsible for… more
- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist, Regulatory Project Management (Evergreen Posting) Requisition ID: 67683 Date: Jan 11, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... Affairs Description: **Thank you for your interest in our Sr Specialist, Regulatory PM (Evergreen) position. Applicants of this role will not be receiving immediate… more
- Lilly (Indianapolis, IN)
- …commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams comprised of process chemists, analytical chemists, ... synthetic organic and process chemistry techniques to address key CMC challenges + Lead and/or supervise the...ideas for future work plans + Experience with modern analytical techniques and process analytical technologies (PAT)… more
- Gilead Sciences, Inc. (Oceanside, CA)
- …individual to work on innovative CAR-T cell therapy for cancer treatment. As a Senior Statistician II in the Statistical Sciences & Analytics (SS&A) group of Network ... and GMP manufacturing for Kite's engineered autologous T cell therapy products. The Sr . Statistician will also help establish a statistics center of excellence to… more
- Frontier Medicines (South San Francisco, CA)
- …equipment, and scale-up challenges + In collaboration with the Development Project Lead and/or CMC Head, define timelines, production scale, and budget ... Medicines is seeking a highly motivated individual for a newly created Director/ Senior Director role in Process Chemistry in either Frontier's South San Francisco… more
- Cambrex High Point (Durham, NC)
- …and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years ... where You Matter by applying today! Job Overview Execute analytical methods and provide general analytical support,...participate in client level meetings, with approval + May lead and develop other team members. + May advise… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position:** Principal Scientist/ Senior Principal Scientist, Analytical Development **Location:** ... will provide analytical subject matter expertise, drive analytical and relevant CMC strategy within cross-functional...be accountable as an individual contributor and as an analytical matrix team lead to support … more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. ** Analytical Chemist - Process Development Senior Scientist** **What you will do** ... Let's change the world! Amgen is currently seeking a Sr . Scientist - Analytical Chemist in our...activities at contract manufacturing and testing sites. + May lead and develop a small group of scientists. **What… more
- AbbVie (North Chicago, IL)
- …R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical ... spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We… more
- AbbVie (North Chicago, IL)
- …Parenterals/Eye Care group is seeking a motivated Senior Scientist as a CMC drug product project lead , specifically for parenteral drug product process ... manner, independently or under the direction of a more senior scientific leader. This position will be an integral...Lead cross-functional PDS&T product teams and represent the CMC team and/or PDS&T in interface with PDS&T leadership,… more
- Sanofi Group (Framingham, MA)
- … lead innovation with the global transversal team spanning across the entire CMC scope. It is his/her responsibility to lead the cross-functional iCMC Digital ... large matrix teams across the international Sanofi footprint, reporting progress to Sr stakeholders from CMC /VRD/MSAT functions. The iCMC Digital Transformation… more
- Bristol Myers Squibb (Princeton, NJ)
- …analytical method validation and transfer, including highly complex bioanalytical methods, analytical CMC strategy, stability program, and end to end ... leadership for the CT GO teams. **RESPONSIBILITIES:** + Lead the Cell Therapy Analytical Science &...Proven track record of delivering the analytics and associated analytical CMC strategies for late stage and… more