Director of Oligonucleotide Manufacturing
2 weeks ago
We are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.
Job SummaryThe Director of Drug Substance Manufacturing at QurAlis plays a pivotal role in developing and optimizing chemical processes for Oligonucleotides production and overseeing the refinement of external manufacturing processes.
Key Responsibilities- Oversee the operation of drug substance manufacturing at our Contract Manufacturing Partners, ensuring compliance with all regulatory, safety, and quality standards.
- Develop and optimize scalable chemical processes for the synthesis of drug substances, focusing on efficiency, yield, and purity.
- Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
- Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
- Manage relationships with contract manufacturing organizations and ensure they meet our quality and production requirements.
- Prepare technical reports and presentations to communicate results and progress to internal and external stakeholders.
- Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent, with significant experience in Oligo chemistry.
- Proven track record in Active Pharmaceutical Ingredient process development, including scale-up and technology transfer, coupled with a deep understanding of synthetic organic chemistry.
- Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
- Experience in working with CMOs and managing external partnerships.
- Excellent communication, organizational, and project management skills.
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Director of Oligonucleotide Manufacturing
2 weeks ago
Cambridge, Massachusetts, United States QurAlis Full timeAbout QurAlisWe are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.Job SummaryThe Director of Drug Substance Manufacturing plays a pivotal role in...
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Head of Oligonucleotide Biology
4 days ago
Cambridge, Massachusetts, United States Simcere Full timeSenior/Executive Director of CNS DiscoverySimcere Pharmaceutical Group is a pharmaceutical company driven by innovative R&D, committed to providing cutting-edge medicines for patients across core therapeutic areas, including oncology, CNS disorders, autoimmunity, and infectious diseases. Our Boston Innovation Center is dedicated to developing transformative...
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Product Technical Lead
2 weeks ago
Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full timeAbout the RoleWe are seeking an experienced Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team within Technical Operations. As a key member of our team, you will be responsible for developing and transforming genome editing development candidates into therapeutic products.Key ResponsibilitiesCoordinate and support...
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Associate Director, Product Technical Lead
4 days ago
Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full timeAbout Intellia Therapeutics, Inc.Intellia Therapeutics, Inc. is a biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to transform the lives of people living with these conditions by leveraging the power of genome editing.Job SummaryWe are seeking an experienced Associate...
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Associate Director, Analytical Development, CMC
3 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeJob Title: Associate Director, Analytical Development, CMCAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and...
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Regulatory Affairs Director
5 days ago
Cambridge, Massachusetts, United States PSG Global Solutions Careers Full timeAssociate Director Regulatory Affairs CMC Job DescriptionWe are seeking an experienced Associate Director Regulatory Affairs CMC to join our team at PSG Global Solutions Careers. As a key member of our regulatory affairs team, you will be responsible for developing and executing global regulatory CMC strategies for assigned programs.Key Responsibilities:Lead...
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Product Technical Lead
1 day ago
Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full timeAbout the Role: We are seeking a highly skilled Product Technical Lead to join our Small Molecule and Oligonucleotide Process Sciences team at Intellia Therapeutics. As a key member of our Technical Operations department, you will be responsible for developing and transforming genome editing development candidates into therapeutic products. As the Product...
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Associate Director, Analytical Development, CMC
3 weeks ago
Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeAbout the RoleWe are seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team at Agios Pharmaceuticals. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and contributing to the overall CMC strategy...
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Cambridge, Massachusetts, United States Agios Pharmaceuticals Full timeAbout the RoleAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and contributing to the overall CMC strategy of drug...
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Manufacturing Director
3 weeks ago
Cambridge, Massachusetts, United States Vericel Corporation Full timeJob SummaryWe are seeking a highly experienced and skilled Manufacturing Director to lead our Cell Therapy Manufacturing operations at Vericel Corporation. As a key member of our team, you will be responsible for overseeing all aspects of manufacturing, ensuring compliance with cGMP regulations, and driving process improvements to enhance efficiency and...
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Senior IT Manufacturing Director
3 days ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleThe Senior IT Manufacturing Director will oversee and manage all services that enable applications and operations at the shopfloor level of manufacturing production lines. This role involves establishing strategic direction and creating roadmaps to align with organizational goals. The Director will guide and support a team consisting of Chapter...
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Program Management Director
2 weeks ago
Cambridge, Massachusetts, United States AIRNA Full timeAIRNA is a Biotechnology Company Transforming LivesAIRNA is a pioneering biotechnology company with a mission to revolutionize the field of RNA editing. Our team is passionate about transforming lives through our innovative science, and we are seeking a highly creative and experienced program manager to lead our cross-functional team.Job DescriptionWe are...
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Program Management Director
1 day ago
Cambridge, Massachusetts, United States AIRNA Full timeAIRNA is seeking a highly creative and experienced program manager to lead the cross-functional team responsible for advancing our lead program into clinical trials.This individual will collaborate closely with the CSO, clinical, manufacturing, and other functions to progress therapeutic candidates through CTA/IND approval and into first-in-human clinical...
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Program Management Director
3 weeks ago
Cambridge, Massachusetts, United States AIRNA Full timeAIRNA OverviewAIRNA is a biotechnology company pioneering the discovery and development of RNA editing therapeutics to transform lives. Our mission is to bring the precision of gene editing technology with a potent and safe medicine that can be conveniently re-dosed and manufactured.Job DescriptionAIRNA is seeking a highly creative and experienced program...
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Cell Therapy Manufacturing Director
4 weeks ago
Cambridge, Massachusetts, United States Vericel® Corporation Full timeDirector, Cell Therapy ManufacturingVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, is seeking a top-performing manufacturing professional to join our team as a Director, Cell Therapy Manufacturing. This role will be based in our Cambridge, MA location until our new state-of-the-art facility in...
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Director of External Manufacturing Operations
4 weeks ago
Cambridge, Massachusetts, United States QurAlis Full timeJob Title: Director of External Manufacturing OperationsJob Summary:The Director of External Manufacturing Operations at QurAlis plays a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external manufacturing processes for Active Pharmaceutical Ingredients (API),...
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Cambridge, Massachusetts, United States QurAlis Full timeJob Title: Director of External ManufacturingAt QurAlis, we are seeking a highly skilled and experienced Director of External Manufacturing to join our team. As a key member of our CMC team, you will play a pivotal role in supporting the development and optimization of chemical processes for small molecule production and overseeing the refinement of external...
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Director of Cell Therapy Manufacturing
5 days ago
Cambridge, Massachusetts, United States Vericel Corporation Full timeJob SummaryVericel Corporation is seeking a highly experienced and skilled Director, Cell Therapy Manufacturing to lead our cell therapy manufacturing operations. This is a key leadership role that requires a strong understanding of cGMPs, cell biology, and cell culture, as well as experience in managing aseptic processing and small batch size...
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Associate Director
4 weeks ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleThe Associate Director - IT Manufacturing is a key leadership position responsible for overseeing and managing all services that enable applications and operations at the shopfloor level of manufacturing production lines.Key ResponsibilitiesEstablish strategic direction and create roadmaps to align with organizational goals.Guide and support a...
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Senior IT Manufacturing Director
1 day ago
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeAbout the RoleThe Senior IT Manufacturing Director will oversee and manage all services that enable applications and operations at the shopfloor level of manufacturing production lines. This role involves establishing strategic direction and creating roadmaps to align with organizational goals.Key ResponsibilitiesOwn and lead the support organization for the...