- Daiichi Sankyo, Inc. (Bernards, 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 Lead… more
- Tris Pharma (Monmouth Junction, NJ)
- …manage due diligence process, and succinctly present findings and recommendations to senior management Lead critical aspects of the technology partnership ... have an immediate opening in our Monmouth Junction, NJ facility for a Senior Manager, Business Development.The primary role of the Senior Manager, Business… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Scientist - Residual Assays, Analytical R&D We invite individuals who possess a deep passion for promoting lifesaving ... actively seeking an enthusiastic individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, ... RNAi Chemical Development group in Boulder, Colorado. You will lead and drive process development for the enzymatic ligation...and API candidates in our portfolio. Relationships Reports to Senior Director, Chemical Development (within the CMC … more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives… more
- Novo Nordisk Inc. (Boulder, CO)
- …Inc. in December 2021. With a new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, ... small molecules and oligonucleotide products. Relationships This position reports to Senior Director, Chemical Development. Essential Functions Lead the… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...daily pre-formulation/material assessments of API and preclinical formulations + Lead the development of appropriate analytical test… more
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …therapies to patients worldwide. Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory ... as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development,...during development and commercialization. As part of the Regulatory CMC team, you will report to a Senior… 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
- Astellas Pharma (Westborough, MA)
- …or product and the application. **Essential Job Responsibilities:** + Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice ... **Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy)** Do you want to be...with functional peer groups internally and externally, occasionally with senior management. + Advises local teams on regulatory requirements.… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Scientist, CMC Digital Product Development, CMC Digital Product ... the Emerging Technologies team to help digitize our process development, analytical development, and manufacturing workflows and enable cross-functional access to… 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 (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
- 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
- BeiGene (Emeryville, CA)
- **General Description:** Sr . Manager/Associate Director, Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... goals. He/she will also work with functions within the company to support and/or lead new product introduction, new market launches as necessary. This role will be… more
- RTX Corporation (Carlsbad, CA)
- …fuel efficient, lighter weight and more durable for commercial and military applications. + Lead MB-DMI implementation at the CMC Center of Excellence + Lead ... will do Pratt & Whitney is seeking an Engineering Lead - Model Based Definition, Manufacture & Inspection (MBDMI)....focused on the manufacturing maturation of ceramic matrix composite ( CMC ) turbine components. CMCs are an enabling material that… more
- West Pharmaceutical Services (Exton, PA)
- Sr . Specialist, Regulatory Project Mgmt Requisition ID: 66496 Date: Aug 14, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Who ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Research Scientist I will be responsible for lead optimization, API form selection/characterization, pre-formulation, formulation development, manufacture ... aspirations. Join Gilead and help create possible, together. **Job Description** ** Sr . Research Scientist I, Formulation & Process Development** Gilead Sciences,… more
