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Senior Director, Head of Drug Substance
11 hours ago
boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
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Senior Director, Head of Drug Substance
2 months ago
Boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
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Senior Director, Head of Drug Substance
2 months ago
Boston, United States Astria Therapeutics, Inc. Full timeTitle: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...
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Senior Director, Drug Substance
3 months ago
Boston, United States PepGen Full timeJob DescriptionJob DescriptionSenior Director, Drug Substance Position Summary Reporting to the VP, Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing...
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Director Drug Substance Development
12 hours ago
boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
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Director Drug Substance Development
2 weeks ago
Boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
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Director Drug Substance Development
2 weeks ago
Boston, United States STEMSourcing Full timeOur valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...
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Scientist, Drug Substance Development
7 days ago
Boston, United States OSI Full timeScientist – Drug Substance Development Responsibilities Contribute to the process development of peptides, oligonucleotides, conjugates, and key raw materials essential for PepGen's platforms.Collaborate with the discovery and analytical development team to develop optimized chromatography processes for purifying target entities.Assist in managing drug...
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Scientist, Drug Substance Development
6 days ago
Boston, United States PepGen Full timeJob DescriptionJob DescriptionScientist - Drug Substance DevelopmentResponsibilitiesContribute to the process development of peptides, oligonucleotides, conjugates, and key raw materials essential for PepGen’s platforms.Collaborate with the discovery and analytical development team to develop optimized chromatography processes for purifying target...
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Boston, MA, United States AL Solutions Full timeDescriptionLead and develop a drug substance team for preclinical through commercialization to support biologics program advancement.Work with internal and external stakeholders to achieve on time targets.Regulatory data creation to author documentation supporting filings and responses to health authorities globally.Manage leadership and operational...
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Boston, Massachusetts, United States Elektrofi Inc Full timePosition OverviewABOUT ELEKTROFI INCElektrofi Inc is at the forefront of transforming the administration of biologic therapies, empowering patients with the flexibility to choose how they receive essential medications. Our innovative ultra-high concentration microparticle technology addresses the challenges linked to traditional intravenous biologic...
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Senior Manufacturing Engineer
2 weeks ago
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Senior Manufacturing Engineer
1 month ago
Boston, United States DSJ Global Full timeSenior Manufacturing Engineer We are seeking an individual to establish and maintain a new manufacturing process line using cutting-edge technology, including automation, 3-D printing, and robotics. The goal is to identify and implement improvement opportunities, applying lean manufacturing methodologies to ensure simpler, faster, cost-effective, and...
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Boston, United States Elektrofi Full timeABOUT ELEKTROFI Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously biologic therapies by enabling...
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Senior Director of Process Development
2 months ago
Boston, United States Elektrofi Inc Full timeJob DescriptionJob DescriptionDescription:ABOUT ELEKTROFIElektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously...
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Senior Manufacturing Engineer
2 weeks ago
Boston, United States DSJ Global Full timeSenior Manufacturing Engineer We are seeking an individual to establish and maintain a new manufacturing process line using cutting-edge technology, including automation, 3-D printing, and robotics. The goal is to identify and implement improvement opportunities, applying lean manufacturing methodologies to ensure simpler, faster, cost-effective, and...
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Senior Manufacturing Engineer
5 days ago
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Senior Manufacturing Engineer
5 days ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob OverviewAs a key member of the Operations team at BRIOHEALTH SOLUTIONS INC, you will play a crucial role in the successful transition of products from design to manufacturing. Your expertise will be essential in ensuring that new products, modifications, and enhancements are efficiently integrated into production.Key ResponsibilitiesDesign...
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Senior Process Engineer
5 days ago
Boston, Massachusetts, United States CyberCoders Full timeWe are seeking a Senior Process Engineer to join our dynamic team at CyberCoders. This full-time position offers a competitive salary range of $120,000 to $180,000, depending on experience.As a key member of our engineering department, you will collaborate closely with various engineering teams and senior management to spearhead our projects and...
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Senior Manufacturing Engineer
4 hours ago
Boston, United States Boston Scientific Full timeDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and...
(USP) Senior Process Engineer, Drug Substance Manufacturing
2 months ago
We initiated a Phase 2b study, NEST–IN1 to evaluate the safety, immunogenicity, and efficacy of HIL–214 in infants. In addition to infants, we also plan to seek approval of HIL–214 in additional age groups such as older children, adults, and older adults. We expect to report top–line data.
HilleVax has assembled a distinguished team with experience in vaccine development, clinical trial operations, manufacturing, and commercialization, including prior experiencing developing HIL–214 at Takeda Pharmaceuticals.
Objectives / Overview:
This rolewill support late–stage drug substance manufacturing activities performed at the Contract Manufacturing sites to support the HIL–214 program and other programs as needed. This position will have responsibility for providing scientific/technical thought and contribution for author / review of documentation for clinical manufacturing, late–stage process validation and commercialization of drug substance at Contract Manufacturing Organizations (CMOs). This individual will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams to identify gaps and add manufacturing robustness for preparation of engineering lots, and GMP lots through PPQs.
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late–stage clinical development and eventual commercialization.
Responsibilities: Contribute scientific and technical aspects to assist managing relationships with CMOs, CROs and key suppliers. This will include coordination, communication, and technical understanding to assist timely delivery of cGMP products to support clinical trials. Support the creation, development and review of gap assessments, late–stage product development and industrialization. Work closely with CDMOs to support and manage GMP batch manufacture and testing, support deviation investigations, batch review and release of GMP material. Assist in the review of Manufacturing Batch records and sampling plans in collaboration with the CDMO teams. Partner with Quality in development of documentation required to support validation and cGMP manufacturing for sterile products. Collaborate with Regulatory Affairs partners ensuring Health Authority requirements are satisfied. Partner with MSAT to drive vaccine technology transfer and scale–up of process improvements as required at the CMOs. Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness. Travel as required to CMO and key vendors for Manufacturing oversight and partnership for commercialization purposes. Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs. Education, Experience & Skills: BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 6–10 years in the GMP manufacturing environment (Ph.D. with minimum of 5 years). Experience / understanding of technical areas related to processes, unit operations and functions involved in drug substance manufacturing (e.g. Cell Expansion, Viral production, Yeast fermentation, SU Bioreactors, Harvest and Clarification) Direct experience in tech transfer and GMP manufacturing activities at the CDMOs Demonstrated ability to work effectively in a team–oriented CMC environment. Excellent communication skills, both written and oral. Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, and analytical development. Proficiency in statistical software for data analysis and tracking and trending. Proven experience in a matrix environment is preferred. Demonstrated ability to work efficiently across multiple project teams and business functions. Demonstrated skills in Hillevax's Core Competencies: Leadership Drive, Intensity, Enthusiasm Goal Orientation/Commitment to Task/Follow–up Teamwork Attention to Quality & Detail Decision Making & Problem Solving Flexibility HilleVax is a biopharmaceutical company focused on the development and commercialization of novel vaccines. Our initial program, HIL–214, is a virus–like particle–based vaccine candidate in development for the prevention of moderate–to–severe acute gastroenteritis (AGE) caused by norovirus infection.
We initiated a Phase 2b study, NEST–IN1 to evaluate the safety, immunogenicity, and efficacy of HIL–214 in infants. In addition to infants, we also plan to seek approval of HIL–214 in additional age groups such as older children, adults, and older adults. We expect to report top–line data.
HilleVax has assembled a distinguished team with experience in vaccine development, clinical trial operations, manufacturing, and commercialization, including prior experiencing developing HIL–214 at Takeda Pharmaceuticals.
Objectives / Overview:
This rolewill support late–stage drug substance manufacturing activities performed at the Contract Manufacturing sites to support the HIL–214 program and other programs as needed. This position will have responsibility for providing scientific/technical thought and contribution for author / review of documentation for clinical manufacturing, late–stage process validation and commercialization of drug substance at Contract Manufacturing Organizations (CMOs). This individual will work with a cross functional team across Tech Ops, including CMC Development, MSAT, Supply Chain, and Analytical Development teams to identify gaps and add manufacturing robustness for preparation of engineering lots, and GMP lots through PPQs.
We provide ample scientific challenges enabling you to have a real impact in an environment where you get the opportunity to take part in the entire biotech value chain from the earliest drug discovery all the way through late–stage clinical development and eventual commercialization.
Responsibilities: Contribute scientific and technical aspects to assist managing relationships with CMOs, CROs and key suppliers. This will include coordination, communication, and technical understanding to assist timely delivery of cGMP products to support clinical trials. Support the creation, development and review of gap assessments, late–stage product development and industrialization. Work closely with CDMOs to support and manage GMP batch manufacture and testing, support deviation investigations, batch review and release of GMP material. Assist in the review of Manufacturing Batch records and sampling plans in collaboration with the CDMO teams. Partner with Quality in development of documentation required to support validation and cGMP manufacturing for sterile products. Collaborate with Regulatory Affairs partners ensuring Health Authority requirements are satisfied. Partner with MSAT to drive vaccine technology transfer and scale–up of process improvements as required at the CMOs. Prepare and review CMC sections of regulatory filings and interfacing with the regulatory agencies. Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness. Travel as required to CMO and key vendors for Manufacturing oversight and partnership for commercialization purposes. Partner with key functions including Quality, Project Management, Clinical Operations, Finance and Regulatory Affairs. Education, Experience & Skills: BS / MS in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 6–10 years in the GMP manufacturing environment (Ph.D. with minimum of 5 years). Experience / understanding of technical areas related to processes, unit operations and functions involved in drug substance manufacturing (e.g. Cell Expansion, Viral production, Yeast fermentation, SU Bioreactors, Harvest and Clarification) Direct experience in tech transfer and GMP manufacturing activities at the CDMOs Demonstrated ability to work effectively in a team–oriented CMC environment. Excellent communication skills, both written and oral. Knowledge of cGMP practices as applicable to technology transfer, manufacturing, drug substance, and analytical development. Proficiency in statistical software for data analysis and tracking and trending. Proven experience in a matrix environment is preferred. Demonstrated ability to work efficiently across multiple project teams and business functions. Demonstrated skills in Hillevax's Core Competencies: Leadership Drive . click apply for full job details
