Senior QA Drug Substance Ops - Gene Therapy
Ultragenyx Pharmaceutical
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 compliance for drug substance and aseptic filling. You will partner with Manufacturing, Engineering, Validation, QC, Quality Systems, and MSAT to approve procedures, batch records, and change controls. #J-18808-Ljbffr Ultragenyx Pharmaceutical
- 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...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
- ...possibilities As Quality Assurance Drug Substance (DS) Specialist, you will be... ...activities at the new gene therapy manufacturing facility located... ...MA. You will provide direct QA oversight and support for the... ...schedule is Work Model: Core Lab & Ops: This role typically requires...SeniorShift work
$105.3k - $130.1k
Senior Specialist, Quality Assurance Operations Bedford... ...As Quality Assurance Drug Substance (DS) Specialist, you... ...activities at the new gene therapy manufacturing facility... ...will provide direct QA oversight and support... ...Work Model: Core Lab & Ops: This role typically requires...SeniorFull timeWork at officeLocal areaShift work$122k - $150k
...Senior Specialist, GMP Quality Assurance Waltham, Massachusetts... ...to our mission of developing therapies that give people the power to... ...collaborate internally with QA, RA, and CMC departments. As... ...Specialist will perform review of drug substance/drug product manufacturing...SeniorFull timeLocal areaFlexible hours3 days per week$117k - $165k
...Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for... ...motivated Quality Systems Manager/Senior Manager, with a strong background in owning... ..., Manufacturing, Supply Chain, QC, and QA stakeholders to define business...SeniorFull timeLocal areaFlexible hours$100k - $115k
...Description Job Description The field of gene therapy is growing rapidly and Genezen is here... ...therapy manufacturing operations, the Senior Quality Assurance Specialist champions... ...in 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...
$200k - $260k
...bringing the next wave of therapies for cancer patients.... ...well as novel antibody-drug conjugates. By leveraging... ...are seeking a Director/Senior Director, GMP Quality... ...working cell bank, drug substance, drug product, and... ...supply demand. Lead QA input into CDMO selection...SeniorContract workTemporary workFlexible hours- Scorpion Therapeutics in Burlington, MA, is seeking a Manufacturing Compliance Specialist to ensure compliance in cell therapy operations. This role involves leading deviation investigations, managing quality systems, and technical support for manufacturing processes. The...SeniorCasual workMonday to Friday
$200k - $260k
...company bringing the next wave of therapies for cancer patients. The... ...antibody, as well as novel antibody-drug conjugates. By leveraging... ...We are seeking a Director/Senior Director, Quality Management Systems... ..., and efficiency. Provide QA oversight of GxP computerized...SeniorContract workTemporary workFlexible hours- 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
$115.5k - $167.5k
...pioneering engineered cell and gene therapies to deliver transformative... ...looking for a highly motivated Senior Manager/Associate Director... ...viral vector and ancillary drug substance manufacturing across a network... ...Partner closely with QA, MS&T, QC, CMC Project Management...SeniorFull timeContract workLocal area- 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
- Amgen Inc. is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies group in Cambridge, MA. The successful candidate will leverage their background in organic chemistry and/or biochemistry to invent synthetic routes and...SeniorRemote jobFlexible hours
$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$160k - $180k
...follow-on product candidate, OP-3136, is a potent KAT6 inhibitor... ...to developing better therapies and a passionate team dedicated... ...manufacture of small molecule drug substances (Active Pharmaceutical Ingredients... ...Pharmaceutical GMP / GMP QA role Experience with small molecule...Work experience placementWork at officeFlexible hours- Sana Biotechnology, Inc. is seeking a Senior Director to lead the company’s IP strategy in cell and gene therapy. You will draft and prosecute patents, manage global portfolios, and guide landscape analyses. Collaboration with R&D and external counsel is essential to align...Senior
- 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
$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$145k - $196k
...new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers,... ...and release testing for raw materials, starting materials, and drug products in support of our commercial operations. This...SeniorFull timeContract workWork at officeFlexible hours3 days per week$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- ...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
- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight across CMC development, Quality Control,... ...Provide quality oversight for GMP manufacturing activities across drug substance and drug product operations, including external manufacturing...SeniorFull timeContract workImmediate start
$136k - $170k
...system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We're looking for people who... .... Manager will foster collaboration and deliver proactive QA guidance throughout the trial lifecycle. Responsibilities...Senior$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- What you will do Amgen is currently seeking a talented Process Development Senior Scientist to join our Drug Substance Technologies - Synthetics (DSTS) group at Cambridge, MA. Amgen’s DSTS group within Process Development (PD) is responsible for the invention and development...SeniorContract workRemote workFlexible hours
- ...company bringing the next wave of therapies for cancer patients. The Company’s... ...antibody, as well as novel antibody-drug conjugates. By leveraging multiple... ...for intermediate material, Drug Substance/Drug Product and collaborate with QA to facilitate batch disposition...Contract workTemporary workWork at officeFlexible hours
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