- 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
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. 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
- Lilly (Philadelphia, PA)
- …**Responsibilities:** + Responsible for the generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions ... + Develop and maintain tools to effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior leadership + Review… 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
- AbbVie (South San Francisco, CA)
- …and novel modalities, to human clinical studies and eventual licensure. AbbVie's Biologics CMC Analytical Research and Development Group in South San Francisco ... role, you will report to the Process Analytics team lead and be responsible for analytical testing...capture, metadata capture, and reporting. + General understanding of CMC Analytical Development of protein therapeutics is… 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
- Boehringer Ingelheim (Duluth, GA)
- …for our employees. As a direct report to the HRD of Animal Health, the Senior Associate Director, HR Operations - AH is instrumental in translating and executing the ... US Animal Health HR strategy. This position takes the lead on prioritized initiatives and projects across the US...Health division, HR COE initiatives, and OPU initiatives. The SR AD, HR Operations - AH is charged with… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist - Analytical Development (AD) Synthetic Molecules - Early ... the department and potentially across CMC (eg CMC team AD representative or team lead )....around cross-functional issues. + Identify topics for initiatives and lead local/global initiatives as directed by senior … more
- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist, Regulatory Project Management (Evergreen Posting) Requisition ID: 67683 Date: Oct 16, 2024 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
- 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 Frontier's South San Francisco office.… 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …and key stakeholders. The Senior Scientist may also serve as a drug product analytical lead who will drive analytical strategy and support for small ... Senior Scientist will collaborate as an individual contributor or drug product analytical lead within project matrix teams for multiple development candidates… more
- AbbVie (North Chicago, IL)
- …Science & Technology (PDS&T) is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral ... team of scientists and leaders driving the advancement of industry-leading analytical capabilities and AbbVie's pipeline of innovative medicines. Careers in AbbVie… more
- Amgen (Cambridge, MA)
- …labs. + Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls ( CMC ) sections in regulatory documents. + ... us and transform the lives of patients while transforming your career. Process Development Senior Scientist - Analytical Chemist **What you will do** Let's do… 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 ... protocols, reports, etc.), scientific publications, presentations, and regulatory documents. + Lead scientific experiments designed to screen platform analytical … 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
- Sanofi Group (Waltham, MA)
- …the vaccines' thermostability, potency, and manufacturing process. + Collaborate with Research, CMC Analytical Science, and others to provide a deep ... millions of patients around the world. As an experienced Senior Scientist in the LNP Platform Development Team, you...This role will work across multiple teams and functions ( CMC drug product development, analytical science, Research,… more
- AbbVie (North Chicago, IL)
- …conjugate drug substances, from FIH programs to late-stage development. The candidate will lead a group of scientists in the development of conjugation chemistry as ... supervisory responsibilities. The candidate will serve as the chemistry representative on the CMC team for ADC development programs and as such would be responsible… more