- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within ... project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main… more
- BioAgilytix (San Diego, CA)
- …a pivotal role in driving our company's growth and market presence for CMC analytical services. In this critical position, you will be responsible for identifying, ... a CRO, CMO, or drug development organization. Working knowledge of selling GMP CMC analytical development and testing services for biologics and cell and gene… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Director/Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director ... medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device product,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …They will be accountable for Design data structure to connect discrete and non-discrete manufacturing data from internal manufacturing sites across the globe ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing ... integrated CMC product strategy based on a cross functionally designed...responsibility to be an interface with R&D as the CMC working group leader of GPT. He/she will supervise… more
- Insmed Incorporated (San Diego, CA)
- …liaison between R&D and Analytical Development for transfer of research bioassays into the CMC space prior to elevation of a drug candidate to CMC development ... will collaborate with R&D and lead cell line engineering efforts focused on CMC bioassay development activities to ensure an appropriate Mechanism of Action potency… more
- Merck & Co. (Rahway, NJ)
- …with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of portfolio, initiatives ... solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other… 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 ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and...pipeline by managing internal manufacturing of API for RNAi CMC Boulder. In addition to ensuring the supply of… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... and packaging activities as well as supply chain documentation to support critical CMC activities . Responsible for authoring the Clinical Supplies section of the… 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 ... experience drafting and supporting regulatory submissions Knowledge of biologics CMC development from pre-clinical through clinical to commercialization Knowledge of… more
- Merck & Co. (Rahway, NJ)
- …excellence are expected.JOB RESPONSIBILITIES: The successful candidate will contribute to CMC development of our Company's pipeline, playing an active role in ... both internal and external partners including vendors.Knowledge of biologics CMC development cycle.Demonstrated ability for taking initiative, creativity, and… more
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across organizations such as Regulatory CMC , formulation functions, and clinical functions to ensure timebound progression of ... solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations, Non-clinical, Clinical, and other… more
- Merck & Co. (Rahway, NJ)
- …Additionally, the role will represent the function at internal governance and CMC teams within the new product development and commercialization (NPDC) framework. ... cross-functional interactions. Preferred Experience and Skills: Experience working within CMC frameworks within the bio-pharmaceutical industry.Ability to set and… more
- Merck & Co. (Rahway, NJ)
- …communication skills Preferred Experience and Skills Experience in leadership of CMC development teams.Experience with cell culture process development for both ... biologics and vaccines.Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and controlExperience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion… more
- BioAgilytix (Durham, NC)
- …for the extraction and quantitation of specific nucleic acids for CMC , preclinical and clinical studies supporting the pharmaceutical development of cellular ... and gene therapies, according to GxP principlesPrepare worksheets independentlyAnalyze & interpret dataPrepare summary tablesPeer review raw dataPrepare buffersTroubleshoot assaysDesign assay runs independentlyResponsible for prompt identification and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accommodation. Education:Bachelor's Degree requiredCoding Certification - Certified MedDRA Coder ( CMC ) or equivalent preferred Experience:4+ years of clinical data ... management medical coding experience in a medical device, pharmaceutical company, or similar environment (eg, CRO) requiredOncology, immunology, or complex disease clinical trial experience preferredMust have a strong understanding and utilization of medical… more
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... & ensuring stable supply of product. - Primary activities include, but are not limited to: - Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical… more
- Merck & Co. (Rahway, NJ)
- …Technical experience that includes LC-MS, GC-MS and/or ICP-MS. Working knowledge of CMC filing requirements and regulatory guidance's ( eg , ICH) for API ... Experience working with CMO's and CRO's Demonstration of working in cross-functional team Strong interpersonal skills including the ability and sensitivity to deal with different cultures Current Employees apply HERE Current Contingent Workers apply HERE US… more
- Merck & Co. (Rahway, NJ)
- …three (3) years of direct people leadership experienceProven track record of CMC development for new product introduction and product life cycle managementExperience ... in building and leading cross-functional, project teamsKnowledge of regulatory requirements and experience with relevant regulatory agencies (FDA, EMA, PDMA, etc.)Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents… more
- Merck & Co. (Rahway, NJ)
- …human health.- In this role, the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a ... matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment.- This individual will also be responsible for driving new technology… more
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