Senior Director, Quality Control Dyne Therapeutics IncSenior Director, Quality ControlWaltham, MA$240,000–$285,000 / yearThe Senior Director partners closely with contract manufacturing and testing organizations and collaborates across Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management to advance quality and business objectives. Role Summary: The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing, pipeline advancement, and product lifecycle management.
Manager, Quality Control Consultant The Steely GroupManager, Quality Control ConsultantHybrid, Waltham, MAThe selected candidate will work collaboratively with Analytical Quality Control leaders to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs and Quality Assurance to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities. Contribute to regulatory and technical documentation by reviewing QC data for accuracy, completeness, and traceability; verifying data transcription and data checks supporting regulatory submissions; and ensuring information is ready for inclusion in internal reports, APQRs, Module 3 submission-supporting documents, and responses to regulatory authorities.
Vice President, Quality Control Candel Therapeutics Inc.Vice President, Quality ControlNeedham, MA$290,000–$335,000 / yearThe Vice President, Quality Control will provide strategic, technical, and operational leadership for all Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. This role will work closely with CMC leadership, Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Development, Supply Chain, Program Management, external laboratories (CROs/CDMOs), and executive leadership.
Quality Control Technician PhilipsQuality Control TechnicianBedford, MA$27.46–$43.94 / hourYou're the right fit if: You have a minimum of 2+ years experience in FDA/ISO 13485 regulated Medical Device manufacturing quality environments, with a focus on production controls, supporting validations, administering calibration, quality records, incoming/in-process/final Inspection, using hand tools and optical inspection systems. The Quality Control Technician is responsible for supporting highly complex quality control tasks to address manufacturing abnormalities, and coordinates quality control protocols while ensuring adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
NewDirector, External Quality Control & Stability Centessa Pharmaceuticals, LLCDirector, External Quality Control & StabilityBoston, MA$150,000–$210,000 / yearCentessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. The Director, External Quality Control & Stability will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development.
Senior Manager, Quality Control Stoke Therapeutics, Inc.Senior Manager, Quality ControlBedford, MA$172,000–$192,000 / yearManager, Quality Control (QC) is responsible for overseeing all aspects of GMP testing and supporting stability program management for Stoke' IMPs at Stoke's Contract Testing Laboratories (CTLs) / Contract Manufacturing Organizations (CMOs). Oversee day-to-day management of outsourced GMP release testing at various CTLs / CMOs to ensure successful and compliant execution of laboratory operations to meet GMPs, regulatory requirements, guidelines, internal policies, and procedures.
Senior Manager/Associate Director, Quality Control Xenon PharmaceuticalsSenior Manager/Associate Director, Quality ControlNeedham, MassachusettsLead the assigned program’s stability activities, including trending, statistical evaluation, and scientific interpretation of stability data to assess product performance throughout its lifecycle, support shelf-life extensions and expiry dating justifications, and proactively identify and evaluate emerging stability risks and trends. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Senior Scientist I, Quality Control Candel Therapeutics Inc.Senior Scientist I, Quality ControlNeedham, MA$155,000–$160,000 / yearThis position collaborates with external manufacturing and tech transfer and is focused on Adenovirus and Herpesvirus vectors, associated cell-based potency assays, as well as performing training of new technical staff and troubleshooting and validation of new and established assays. The Senior Scientist I, Quality Control works with various cell lines, performs analytical methods, trends quality attributes, and suitability of product lines for continued use.
Quality Control / Documentation Analyst Katalyst Healthcares & Life SciencesQuality Control / Documentation AnalystLexington, MAJob 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.
Technical and Craft Labor - Quality Control Technician MindlanceTechnical and Craft Labor - Quality Control TechnicianTewksbury, MAWe are seeking a detail-oriented and technically skilled Quality Control Technician to support the testing and quality of advanced handheld X-ray devices used across the safety & security, mining and minerals, and pharmaceutical industries. The ideal candidate will have experience in quality inspection, electronics or instrumentation testing, and a strong commitment to safety, precision, and continuous improvement in a high-tech manufacturing environment.
Vice President, Quality Control Candel TherapeuticsVice President, Quality ControlNeedham, MA$290,000–$335,000 / yearPosition SummaryThe Vice President, Quality Control will provide strategic, technical, and operational leadership for all Quality Control functions supporting the development, manufacture, release, and lifecycle management of viral vector and advanced therapy products. This role will work closely with CMC leadership, Analytical Development, Process Development, Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Development, Supply Chain, Program Management, external laboratories (CROs/CDMOs), and executive leadership.
Senior Scientist Bioassay Development And Quality Control SanofiSenior Scientist Bioassay Development And Quality ControlWaltham, MA$100.50–$145.17 / hourServe as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassays. Preferred Qualifications: Experience with flow cytometry, FRET-assays, effector function assays, reporter cell lines, PCR analysis and/or ELISA endpoints, DOE approaches where appropriate.
Senior Scientist Bioassay Development and Quality Control SanofiSenior Scientist Bioassay Development and Quality ControlWaltham, MA$100.50–$145.17 / hourServe as a subject matter expert (SME) for biological potency assays for viral and non-viral products, define the best scientific approaches and analysis methods for quantitative bioassays. Preferred Qualifications: Experience with flow cytometry, FRET-assays, effector function assays, reporter cell lines, PCR analysis and/or ELISA endpoints, DOE approaches where appropriate.
Quality Control Co-op Beam Therapeutics IncQuality Control Co-opCambridge, MA$23–$34 / hourBeam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This role is intended to support PLI readiness, method lifecycle activities, laboratory organization, reagent traceability, and quality-system-related activities while providing hands-on exposure to a GMP-regulated laboratory environment.
Director, Global Quality Control Scholar Rock Holding CorpDirector, Global Quality ControlCambridge, MA$200,000–$240,000 / yearThis role provides technical and operational leadership for commercial release and stability testing, specification lifecycle management, analytical method lifecycle activities, external laboratory oversight, and QC support for post-approval changes, regulatory commitments, and global market supply. 10+ years of progressive Quality Control and/or Analytical Sciences experience in the biotech/pharma industry, including significant experience supporting commercial GMP products and outsourced operating models; prior people leadership or matrix leadership experience preferred.
Senior Scientist I, Quality Control Candel TherapeuticsSenior Scientist I, Quality ControlNeedham, MA$155,000–$160,000 / yearThis position collaborates with external manufacturing and tech transfer and is focused on Adenovirus and Herpesvirus vectors, associated cell-based potency assays, as well as performing training of new technical staff and troubleshooting and validation of new and established assays. The Senior Scientist I, Quality Control works with various cell lines, performs analytical methods, trends quality attributes, and suitability of product lines for continued use.
Associate Director, Quality Control Xenon PharmaceuticalsAssociate Director, Quality ControlNeedham, MassachusettsLead the assigned program’s stability activities, including trending, statistical evaluation, and scientific interpretation of stability data to assess product performance throughout its lifecycle, support shelf-life extensions and expiry dating justifications, and proactively identify and evaluate emerging stability risks and trends. Strong experience with quality control testing, stability program management in accordance with ICH guidelines, master specifications, method validations, investigations (OOS/OOT), batch release processes, and quality management systems is required.
Associate Director, Quality Control (56861) Praxis Precision MedicinesAssociate Director, Quality Control (56861)Boston, MAPraxis is seeking a highly experienced, motivated, and innovative quality leader with strong experience in late-stage development and commercialization to join our Quality team as Associate Director, Quality Control to support QC product release and stability activities. Reporting to Senior Director, Quality Operations CMC, this position will be responsible for managing and executing Quality Control activities in support of product testing, release, and stability, and toxicology studies test material inventory support.
Quality Control / Documentation Analyst Karwell TechnologiesQuality Control / Documentation AnalystLexington, MAJob 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, Global Quality Control Scholar RockDirector, Global Quality ControlCambridge, MAThis role provides technical and operational leadership for commercial release and stability testing, specification lifecycle management, analytical method lifecycle activities, external laboratory oversight, and QC support for post-approval changes, regulatory commitments, and global market supply. Lead and manage key elements of Scholar Rock’s commercial QC function across a fully outsourced model, with direct oversight of external QC laboratories, CMOs, and contract partners supporting commercial drug substance, drug product, raw material, in-process, release, and stability testing.