Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract) Rentschler BiopharmaQuality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)Milford, MassachusettsThe Quality Control Analyst II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods, stability protocols, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). SME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances.
Quality Control Data Reviewer Rentschler BiopharmaQuality Control Data ReviewerMilford, MassachusettsAs part of the Milford site’s Quality Control team, the Data Reviewer is responsible for the cGMP analytical data review and documentation generated during laboratory analysis in the quality control laboratory. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law.
Director, Quality Control Editas Medicine, Inc.Director, Quality ControlCambridge, MA$215,000–$235,000 / yearThe successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance, to transfer, qualify and oversee in-process and release testing to advance Editas' in vivo gene medicine portfolio. Characterizing Your Impact: As the Director, Quality Control, you will: Lead phase appropriate CMC analytical development, qualification/validation, transfer and optimization through strong collaboration with key stakeholders and external partners.
Quality Control Analyst I, Raw Materials Ocular TherapeutixQuality Control Analyst I, Raw MaterialsBedford, MA$68,000–$75,000 / yearOcular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX. Key Responsibilities: The primary responsibilities of this role will be performing qualitative and quantitative testing of raw materials using techniques such as HPLC, GC, FTIR, UV-Vis, titration, and wet chemistry.
Quality Control Analyst- Gas Operations EversourceQuality Control Analyst- Gas OperationsSouthborough, MA$95,600–$106,220 / yearRole and Scope of Position: Supports the implementation, of the Eversource Quality Control (QC) program as it relates to any of the following construction, maintenance, meter service, leak survey, corrosion, damage prevention, LNG and I&R activities at Eversource Gas. This role works in an environment that often requires the performance of multiple simultaneous activities, where deadlines need to be met and work is performed under pressure while involving significant business commitments and results.
Environmental Monitoring Associate - Quality Control TandymEnvironmental Monitoring Associate - Quality ControlBedford, Massachusetts$32 / hourThis role supports controlled manufacturing operations by performing environmental monitoring, utility sampling, documentation, and microbial enumeration in a GMP-regulated setting. Perform environmental monitoring tasks for aseptic and controlled areas, as well as plant utility systems, following SOPs and GMP documentation.
Scientist, Quality Control Analytical Development (6-month Contract) Rentschler BiopharmaScientist, Quality Control Analytical Development (6-month Contract)Milford, MassachusettsPrimary focus on the execution of experiments to support the validation of molecular biology assays including but not limited to ELISAs for residual HCP, residual protein a, and relative potency assays as well as qPCR. Experience in other biophysical characterization methods CE (capillary electrophoresis), chromatography, SEC/RP/IEX-U(H)PLC, SDS-CGE, iCIEF, CIEX, Peptide mapping is a plus.
Quality Control Analyst (Sun-Wed Shift) Sarepta Therapeutics Inc.Quality Control Analyst (Sun-Wed Shift)Andover, MA$78,400–$98,000 / yearThe successful candidate will have hands-on experience with cell-based in-vitro potency assays, cell culture, SDS-PAGE, western blot, Automated Western blot assays, enzyme activity measurements, protein extraction, purification, and quantification methods. The successful candidate will work within the QC team, testing gene therapy products utilizing cell-based assays (Potency assay) in support of clinical and commercial lot release and stability activities.
Quality Control (Metrology Lab/Med device Night Shift & 2nd) SmcQuality Control (Metrology Lab/Med device Night Shift & 2nd)MassachusettsThis position has primary responsibilities which include accurate part and assembly inspections and tests performed to customer specifications, operating computerized inspection systems, such as coordinate measurement machines and vision inspection equipment. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
Quality Control Analyst LancesoftQuality Control AnalystLexington, MA$34Job Description Assist in document authoring/ revision and approval (protocols, test methods, SOPs) and other routine laboratory activities supporting the lab as 079 activities are completed by the biochem team. This role supports the daily operations of the QC Raw Materials department, whose primary responsibility is the testing and release of raw materials for GMP use in manufacturing.
Director, Quality Control Dyne TherapeuticsDirector, Quality ControlWaltham, MA$190,000–$230,000 / yearThe Director, Quality Control leads global Quality Control activities, including oversight of external laboratories supporting analytical testing, release, and stability programs across clinical and commercial stages. Regulatory, Inspection Readiness & Cross-Functional Collaboration Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities.
Quality Change Control, Project Manager (Contract) 665 Vertex PharmaceuticalsQuality Change Control, Project Manager (Contract) 665Boston, Massachusetts$58–$65 / hourFull timeAgreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
Scientist I, Quality Control ReplimuneScientist I, Quality ControlFramingham, MassachusettsThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs).
Director, Quality Control Editas MedicineDirector, Quality ControlCambridge, MA$215,000–$235,000 / yearThe successful candidate will collaborate with a high-performing CMC team, coordinating with process and analytical experts cross-functionally in Research and Discovery, Process Development, Analytical Sciences, Manufacturing, and Quality Assurance, to transfer, qualify and oversee in-process and release testing to advance Editas’ in vivo gene medicine portfolio. The Quality team is seeking a highly motivated and experienced technical and organizational leader in gRNA, mRNA, and Lipid Nanoparticle (LNP) analytical methodologies and GMP testing.
NewSr. Quality Control Analyst Pace Analytical ServicesSr. Quality Control AnalystWaltham, Massachusetts$105,000–$120,000 / yearDesign and develop robust, scalable formulations for small molecules and biologics in early-stage clinical trials; optimize manufacturing processes for drug products. Analyze and interpret complex chemistry, biochemistry, and formulation data to identify trends and provide actionable insights to management and/or clients.
Sr. Quality Specialist, GxP Document Control Bicara TherapeuticsSr. Quality Specialist, GxP Document ControlBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Sr. Quality Specialist, Gxp Document Control Bicara Therapeutics IncSr. Quality Specialist, Gxp Document ControlBoston, MAFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
Sr. Quality Control Analyst LNN Pace Analytical Life SciencesSr. Quality Control AnalystWaltham, Massachusetts$35–$50 / hourSUMMARY Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
Scientist I, Quality Control Replimune Group, Inc.Scientist I, Quality ControlFramingham, MAThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The QC Analytical Scientist will be required to assist with scheduling, performing and reviewing of tests results of raw materials, in-process, drug substance and final drug product samples following established test method (SOPs).
Quality Control Sample Management Technician - Microbiology (2nd Shift) Rentschler BiopharmaQuality Control Sample Management Technician - Microbiology (2nd Shift)Milford, MassachusettsPerforms a variety of sample management duties, including labeling, preparing samples for shipment, transporting to laboratories or Supply Chain, maintaining inventory, and discarding samples as needed. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law.