We have other current jobs related to this field that you can find below
-
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...
-
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 vital role in the transition of products from research and development to full-scale manufacturing. Your expertise will ensure that products are designed for manufacturability and that processes are optimized for efficiency and quality.Key ResponsibilitiesDesign...
-
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...
-
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...
-
Boston, Massachusetts, United States Replimune Group Full timeOverviewThe Vice President of Chemistry, Manufacturing, and Controls (CMC) plays a pivotal role in leading and managing the manufacturing operations at Replimune. This position is essential for overseeing the global Process Development function, ensuring that all aspects of drug substance and product development are executed effectively. The role encompasses...
-
Manufacturing Engineer
1 month ago
Boston, Massachusetts, United States Motion Recruitment Full timeOur client is at the forefront of innovation in the biotech and medical device industry. Their mission is to develop cutting-edge solutions that improve patient outcomes and revolutionize healthcare. They're seeking a talented and driven Manufacturing Engineer to join their dynamic teamAs a Manufacturing Engineer on the team, you will posses a passion for...
-
Associate Director, Sterile Drug Products
2 weeks ago
Boston, Massachusetts, United States Inozyme Pharma Full timePosition Overview:We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor management and act...
-
Principal Manufacturing Engineer
2 months ago
Boston, Massachusetts, United States Michael Page Full timeGreat opportunity to make an immediate impact on people's livesJoin a mission driven start-up with high performing employees About Our Client My client is a pioneering leader in the medical equipment industry, committed to delivering innovative solutions that enhance patient care and safety. They are committed to providing innovative technologies with the...
-
Principal Manufacturing Engineer
2 months ago
Boston, Massachusetts, United States Michael Page Full timeDo you have manufacturing experience in the medical device industry?Do you want to work on life saving medical devices? About Our Client My client is a Medical Device Manufacturer based out of the Boston, Massachusetts area. They manufacture highly technical, innovate medical devices. Job Description The main responsibilities of the Principal Manufacturing...
-
Lead Advanced Manufacturing Engineer
5 days ago
Boston, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeJob OverviewBrioHealth Solutions Inc. is in search of a seasoned and motivated Lead Advanced Manufacturing Engineer to become a vital part of our innovative team. In this role, you will play a crucial part in the project team, overseeing the design and transition of products and process technologies from Research & Development to Manufacturing, ensuring that...
-
Senior Embedded Engineer
1 month ago
Boston, Massachusetts, United States Motion Recruitment Full timeOur client is a leading consulting firm specializing in the development and manufacturing of medical devices. Their mission is to deliver innovative solutions that improve healthcare outcomes worldwide. With a dedicated focus on quality and compliance, they work with top-tier medical device companies to bring cutting-edge technologies to market. They're...
-
Senior Manager for Manufacturing Readiness
5 days ago
Boston, Massachusetts, United States Vertex Full timeJob Overview:General Summary:Vertex is at the forefront of Biopharma Cell and Genetic Therapies (BCGT), aiming to expedite the delivery of innovative medicines to patients. We are in search of a dedicated Senior Manager to join our dynamic and expanding team. This position will focus on the execution and oversight of the internal manufacturing site readiness...
-
Senior Backend Engineer
2 weeks ago
Boston, Massachusetts, United States Asimov Full timeOur mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics.We are looking for an experienced Senior Backend Engineer with...
-
Senior NPI Quality Engineer
2 months ago
Boston, Massachusetts, United States WHOOP Full timeAt WHOOP, we're on a mission to unlock human performance. WHOOP empowers users to perform at a higher level through a deeper understanding of their bodies and daily lives.As a Senior NPI Quality Engineer, you will work closely with WHOOP Hardware Engineering, Manufacturing, Supply Chain & Operations, and internal Quality teams as you will be responsible for...
-
Senior Backend Engineer, Internal Tools
1 month ago
Boston, Massachusetts, United States Asimov Full timeOur mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics.We are looking for an experienced Senior Backend Engineer with...
-
Senior Engineering Assembly Technician
2 months ago
Boston, Massachusetts, United States Adecco Staffing, USA Full timeAdecco Staffing is working with a growing R&D/manufacturing company in Boston, MA. We are looking for an experienced Senior Engineering Assembly Technician. This is a temp to perm or direct-hire opportunity.Pay Rate Range: $40 - $45 per hourSchedule(s)/Hours: Monday – Friday 9:00 AM - 5:00 PMPosition Title: Senior Engineering Assembly TechnicianSummary:The...
-
Senior Backend Engineer, Internal Tools
2 weeks ago
Boston, Massachusetts, United States Asimov Full timeOur mission at Asimov is to advance humanity's ability to design living systems, enabling biotechnologies with outsized benefit to society. We're developing a mammalian synthetic biology platform––from cells to software––to enable the design and manufacture of next-generation therapeutics.We are looking for an experienced Senior Backend Engineer with...
-
Senior Firmware Engineer
1 month ago
Boston, Massachusetts, United States Michael Page Full timeJoin a fast growing family owned global organizationWork 4 days on-site and 1 day remote About Our Client The company are a family owned organization in the scientific instrumentation manufacturing industry. Job Description The Senior Firmware Engineer / Embedded Software Engineer will be responsible for specifying, implementing, optimizing and validating...
-
Senior Software Engineer
1 month ago
Boston, Massachusetts, United States Motion Recruitment Full timeSenior Software EngineerOur client is a leading provider of cutting-edge security solutions designed to protect and enhance the safety of people and assets. Based in Massachusetts, they leverage advanced technology to deliver state-of-the-art security systems that integrate seamlessly into a variety of environments. They are committed to innovation,...
-
Senior Mechanical/Electrical Engineer
5 days ago
Boston, Massachusetts, United States Motion Recruitment Full timeLocation: MassachusettsEmployment Type: Hybrid, Full TimeSalary: $170,000 - $200,000Our client is an innovative robotics start-up focused on transforming the transportation landscape through state-of-the-art technology. Their goal is to create the next generation of autonomous vehicles that prioritize safety, efficiency, and reliability.They are currently...
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
