Senior QA Specialist, Gene Therapy Drug Substance Ops
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Ultragenyx Pharmaceutical in Bedford, MA seeks a Quality Assurance Drug Substance (DS) Specialist to oversee QA activities for a gene therapy manufacturing site. You will review batch records, perform deviations management, and collaborate across Manufacturing, Engineering, QC, and Quality Systems to approve DS manufacturing procedures and records. This role reports to the Associate Director, QA and requires on-site presence. #J-18808-Ljbffr Socket
- Ultragenyx Gene Therapy in Bedford, MA is seeking a Quality Assurance Drug Substance Specialist to oversee QA activities at the new gene therapy manufacturing facility. You will provide QA oversight for DS manufacturing, review batch records, deviations, and ensure GMP...Senior
- Ultragenyx Gene Therapy in Bedford, MA is seeking a Senior Specialist, Quality Assurance Operations to oversee QA activities for drug substance manufacturing at a new gene therapy facility. You will review batch records, manage deviations, and support manufacturing approvals...Senior
$100k - $115k
...Job Description The field of gene therapy is growing rapidly and Genezen is... ...therapy manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day to... ...batch disposition activities. QA support of drug product aseptic fill operations and...SeniorLive inVisa sponsorshipShift work- The Steely Group is seeking a CMC QA Consultant to support cross-functional teams across PD, MSAT, CMC, Manufacturing and Regulatory Affairs to ensure quality and compliant controls for gene therapy programs. You will review batch records, deviations, tech transfers, and...Suggested
- Merida Biosciences is seeking a Sr. Manager / Associate Director to lead late-phase drug substance PD/MSAT, interfacing with a CDMO and the CMC team to drive strategy and execution. You will guide process characterization, PPQ development, and regulatory deliverables in...Senior
- Relay Therapeutics in Cambridge, MA is seeking a seasoned process chemist to lead drug substance development, scale-up, and external manufacturing collaborations across programs from late research through clinical trials. You will manage tech transfer to global CRO/CDMOs...Senior
- Orna Therapeutics, Inc., a Lilly subsidiary based in Watertown, MA, seeks a Senior Advisor to lead downstream process development and scale-up for circular RNA drug substances. The role emphasizes design of experiments, process optimization, and cross-functional transfer...Senior
- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control, Analytical Development... ...oversight for GMP manufacturing activities across drug substance and drug product operations, including external...SeniorFull timeContract workImmediate start
- Amgen is seeking a Process Development Senior Scientist to lead development, characterization, scale-up, and support of drug substance processes for late-stage programs. You will work with cell culture and purification experts to advance a diverse pipeline, contributing...Senior
$122k - $174k
...Opportunity:Are you a seasoned process chemist who enjoys working on drug substance projects? Do you love working closely with pharmaceutical... ...discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein...SeniorContract work$173k - $285.33k
...committed to discovering and developing novel small molecule drugs for indications in virology and immunology. Our... ...improving patient outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will be an integral part of our CMC team...Senior$202.94k - $274.57k
...part of the Amgen team. Join us and transform the lives of patients while transforming your career.Senior Director - Head of Process Engineering (Synthetic Drug Substance Process Development)What you will doLet’s do this. Let’s change the world. Would you like to lead a...SeniorFull timeContract workFlexible hours$141k - $228.8k
...committed to developing groundbreaking therapies for diseases that current approaches cannot... ...Summary We are seeking an exceptional Senior Advisor to join our team. The candidate... ...technical development and scale‑up of drug substance processes. The ideal candidate will...SeniorFull timeFlexible hours- Dyno Therapeutics is seeking a Senior Research Associate to advance animal studies and identify muscle AAV-based capsids. You will... ...optimize workflows, troubleshoot issues, and ensure high-quality data to inform gene therapy programs. #J-18808-Ljbffr Dyno TherapeuticsSenior
- ...teams, vendors, budgets, and timelines, ensuring ICH/GCP compliance and data integrity. You will collaborate with leadership to advance Gene Writing programs, optimize trial execution, and maintain inspection readiness, delivering high-quality clinical data across programs...Senior
$115.5k - $167.5k
...engineered cell and gene therapies to deliver transformative... ...a highly motivated Senior Manager/Associate... ...appropriate manufacturing specialist function that will be... ...vector and ancillary drug substance manufacturing across... ...Partner closely with QA, MS&T, QC, CMC...SeniorContract workLocal area$173.2k - $216.5k
...diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re... ...Sr. Neuromuscular Clinical Sales Specialist (NCSS) is a performance driven individual... ...for newly approved classes of drugs to treat Duchenne Muscular Dystrophy...SeniorFull timeLocal area$250k - $285k
...oncology company bringing the next wave of therapies for cancer patients. The Company’s... ...bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities... ...of DP with DS, AS, QC, supply chain, and QA Prior experience working with ADCs is highly...SeniorContract workTemporary workFlexible hours$220k - $240k
...development and safe manufacture of new drug therapies. When you join our family, you will have... ...development professional to serve as a Senior Principal Scientific Advisor within our... ...therapeutic modalities, including cell and gene therapies, oligonucleotides, RNA-based...SeniorContract workLocal areaRemote workWorldwideFlexible hours$135k - $165k
...management, and contract manufacturing organization (CMO) partners. The Senior Supply Chain Manager provides oversight of CMO partners to... ..., equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time...SeniorFull timeContract workWork at officeFlexible hours$165k - $200k
...Description: Sr. Manager / Associate Director, Late-Phase Drug Substance PD/MSAT At Merida Biosciences, we are pioneering true precision... ...our hiring range for this role upfront: typically for the Senior Manager/Associate Director we target $165,000 to $200,000. The...SeniorLocal area$110k - $120k
...power and potential of CRISPR gene editing to transform the... ...This role is part of a small QA team with opportunities for cross... ...potential best-in-class, one-time therapy designed to significantly... ...Your Impact: As the Senior QA Specialist, you will: Maintain Quality...SeniorFlexible hours- Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility. You'll gown into ISO 7 clean rooms and support release activities...RelocationWeekend work
- The CMC QA Consultant will report to the Director of CMC QA and be responsible for... ...controls are in place for assigned Gene Therapy programs, and working with colleagues to... ...commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory...Contract workLocal area
- ...possibilities As Quality Assurance Drug Substance (DS) Specialist, you will be responsible... ...activities at the new gene therapy manufacturing facility located... .... You will provide direct QA oversight and support for... ...is Work Model: Core Lab & Ops: This role typically requires...SeniorShift work
- Scorpion Therapeutics is seeking a Director of Oral Drug Product Development to lead formulation design, process development, scale‑up, and technology transfer for small molecule oral dosage forms across all development stages. You will mentor scientists, drive cross‑functional...Senior
- Title: Senior Scientist, Drug Product Development & External Manufacturing Location: Cambridge, MA... ...specific kidney cell types, resulting in gene silencing of disease-modifying target... ...characterization of critical drug substance (DS) and drug product (DP) properties...SeniorLocal area
$96.17k - $116.24k
Senior Research Associate As a hands-on molecular biology expert, you will play a key role... ...-quality data that shapes the future of gene therapy. Job Type: Full Time Location:... ...biology, gene therapy, viral vectors, or drug-delivery technologies. Experience with...SeniorFull timeFlexible hoursShift work$122k - $174k
...You will be an integral part of Relay’s drug product development team supporting Relay... ...compoundsYou will coordinate with drug substance, DMPK, toxicology and analytical, to ensure... ...with the goal of bringing life-changing therapies to patients. Built on unparalleled...Senior$71.25k - $187k
...committed to developing groundbreaking therapies for diseases that current approaches cannot... ...Summary We are seeking an exceptional Senior Principal Scientist to join our growing... ...) formulations. Develop and optimize drug substance and drug product LC-MS/MS assays for...SeniorFull timeH1bVisa sponsorshipWork visaFlexible hours
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