Average salary: $144,576 /yearly
More statsSearch Results: 27 vacancies
...trial and regulatory operations, to expedite vaccine candidates to market.Reduce the burden of infectious disease with us. Join our team.CMC Logistics Specialist Location: Bothell, WA, United StatesDate Updated: Mar 14, 2024Job ID: 3758Classification: E xemptReports to: SR....
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...Director/Sr. Director, Regulatory CMC | Seattle, WA |
Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
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...productivity
Assist residents with placing meal and snack orders, taking into consideration any food allergies, cultural preferences and CMC therapeutic diets restrictions (Diabetic, house, real, GI Bland etc.)
Assure accuracy and appropriateness of meal including food...
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...our core values, we'll meet these challenges. Join us!
Alpine Immune Sciences is seeking a highly motivated individual to join the CMC team as a Process Engineer (Upstream) . This individual will be part of a team working to develop upstream processes that are robust...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
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...design and execute experiments related to supporting commercial vector manufacturing processes. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities....
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...Notary Public appointment within 3 months of hire;
~ Certified Municipal Clerk designation or demonstrated progress toward obtaining CMC designation;
~ Flexibility to work late evenings and hours outside of a typical schedule on a regular basis;
~2+ years of...
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...experimental design and data analysis skills. Previous experience in late-stage and first-in-human (FIH) development, participation in CMC teams, and experience authoring regulatory documents is required. This person would be taking on a leadership role and should have...
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...and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service,...
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...oriented environment
Preferred qualifications:
Experience with biosimilar development and biosimilarity studies
Experience in CMC development teams as an Analytical Lead
Experience with early & late stage regulatory filings
Use of liquid-handling automation...
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...programs/initiatives
* Leverages literature, ICH/Regulatory guidance, and practical experience to perform their work and influence CMC strategies
* Authors and reviews technical reports, manufacturing documents, regulatory submissions and publications
* Regularly...
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...Treg biology preferred
~ Experience with statistical data analysis and mammalian gene editing systems preferred
~ Experience with CMC regulatory filings preferred
~ Exceptional teamwork and communication skills
~ Flexibility to pivot from plan A to plan B
~...
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...design and execute experiments related to supporting commercial vector manufacturing processes. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities....
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...Pluripotent Stem Cell (PSC) Process Development. The successful candidate will be responsible for providing strategic and technical CMC leadership in the development of innovative, scalable expansion and differentiation processes for manufacturing PSC-derived cell therapy...
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...analytical packages for regulators across the globe. This role is expected to be about 50% focused on people management, 30% on leading CMC teams and 20% on strategy.
This position plays a strategic and mentoring role in advancing Umoja's pipeline and Analytical...
...BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic...
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...development, and commercialization of novel therapeutic proteins. We are seeking a highly skilled and motivated Scientist to come join our CMC, Process Development team and help drive our early and late stage clinical trials to market. With a dedicated team of scientists and...
...Experience with tangential flow filtration
Statistical software use, such as JMP
Experience with GMP manufacturing
Familiarity with CMC team function
Experience with technology transfer to manufacturing
Work Location Assignment: On Premise
The annual base...
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...as a Senior Scientist II in the Bio DPD group in Lake County. This position will be an integral part of the product development and CMC teams and will have strong collaborations with the formulation and process development, and engineering teams, the Drug Product Pilot...
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