GMP Gene Manufacturing Specialist (Clinical & Commercial)
Precigen
Precigen is seeking a GMP Gene Manufacturing Associate I/II to join a dynamic team responsible for cGMP manufacturing of adenovector products. The role requires attention to detail, proactive improvements, and experience operating GMP process equipment. The position involves assembling materials, executing MBRs, following SOPs, and supporting deviations, clean room changeovers, and technology transfer in a fast-paced environment. Weekend and shift work may be required. #J-18808-Ljbffr Precigen
- GENERAL DESCRIPTION:GMP Gene Manufacturing Associate I/II will require a professional who thrives in a dynamic team environment, brings... ...a broad range of tasks in the cGMP manufacturing of clinical and commercial adenovector products. Prior experience in GMP manufacturing...CommercialTemporary workCasual workShift work
- Precigen, Inc. in Germantown, MD is seeking a GMP Manufacturing Associate I/II to join a dynamic team focused on clinical and commercial adenovector product manufacturing. The role requires GMP experience, attention to detail, and proactive process improvement. The position...CommercialShift work
- ...Experience with the marketing of regulated products is required, including knowledge of GMP manufacturing, regulatory compliance (FDA guidelines), and quality systems in a clinical or commercial setting. Experience working with or within a CDMO (Contract Development and...CommercialFull timeContract workTemporary workLocal area
- GENERAL DESCRIPTION GMP Cleaning Associate will require a professional who thrives in a dynamic team environment, brings... ...position will perform professional cleaning of the GMP manufacturing clinical and commercial areas. Prior experience in cleaning GMP manufacturing areas...CommercialShift work
- The Director, Gene Therapy Manufacturing, Drug Substance, provides leadership, hands-on technical and operational expertise to the manufacturing... ...the current and future manufacturing teams for our clinical and commercial drug substance manufacturing, including project and...CommercialFull timeCasual workShift work
- ...AstraZeneca seeks a Senior Specialist to coordinate end-to-end... ...precise orchestration across clinical operations, manufacturing, logistics, and quality... ...years biopharma clinical or commercial logistics, supply chain,... ...knowledge of GDP, GxP, and GMP requirements and regulated...Commercial
- Precigen is a dedicated commercial and clinical stage biopharmaceutical company... ...the next generation of gene therapies using precision technology... ...has developed novel manufacturing processes to deliver UltraCAR... ...knowledge of FDA, EU GMP, ICH Q7, and pharmaceutical...CommercialContract workTemporary work
- ...Precigen is a commercial and clinical-stage biopharmaceutical company focused... ...novel cancer immunotherapy and gene therapy products designed... ...clinical and commercial manufacturing operations. As the site lead... ...quality programs within a GMP-regulated environment, including...CommercialWork at office
$142.38k - $213.57k
...our growing Cell Therapy and Gene Therapy portfolio. This... ...early development through clinical and commercial readiness.The successful candidate... ...Development, CMC, Manufacturing, Quality, Regulatory, and external... ...implementation at internal GMP sites and external CDMOs....CommercialFull timeTemporary work$217k - $325.49k
...a Senior Director of Manufacturing Science and Technology... ...process validation through commercialization and life cycle... ...supply objectives across clinical and commercial stages.... ...Extensive background in GMP manufacturing... ...in a fast-paced cell & gene therapy field.Collaborative...CommercialFull timeWork at officeRemote workFlexible hours3 days per week$22.01 - $25.91 per hour
This position is responsible for manufacture of biologics (LV) under cGMP conditions. Staff must... ...batch record instruction and complete GMP documentation. Responsible for the proper... ...developments have led to cutting-edge cell and gene therapies - transformative methods that...$241.61k - $362.42k
...Development Medical Director, Late Respiratory and Immunology Clinical DevelopmentAs a Global Development Medical Director, you will... ...into the content of core labelling texts and medical support for commercial activities, support for medical monitoring of clinical studies...CommercialFull timeTemporary workWork at officeFlexible hours3 days per week- ...Regulatory functions for a clinical-stage biotechnology... ...clinical development, manufacturing, testing, and external... ...and toward commercialization. The successful candidate... ...compliance with applicable GMP, GCP, GLP, and other relevant... ..., or cell/gene therapy development, including...Commercial
$68.64k - $83.2k
...Precigen is a dedicated commercial and clinical stage biopharmaceutical company... ...the next generation of gene therapies using precision technology... ...has developed novel manufacturing processes to deliver UltraCAR... ...maintenance within a GMP-regulated pharmaceutical manufacturing...CommercialFull timeCasual workAfternoon shift- ...Overview Clinical Research Associate II US Remote Emmes Group: Building a better future for us all... ...into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology...CommercialWork experience placementInterim roleCasual workLocal areaRemote workWork from homeFlexible hours
- ...US Federal Government, US Military, and Commercial clients. Services include Management & IT... ...Arcetyp LLC is looking for a DoD Medical & Clinical Research Advisor . This position is... ...experience. FDA/IND/IDE experience. CMC/GMP knowledge. Military medicine...CommercialFull timeH1bRemote work
$92.25k - $138.38k
...processes with a primary focus on clinical and commercial scales. You will contribute... ..., CMC, Regulatory, Manufacturing, Quality, and external CDMOs... ...assist transfers to internal GMP sites and CDMOs. ~... ...FDA/EMA guidance relevant to gene and cell therapy; experience...CommercialHourly payTemporary workWork at officeFlexible hours3 days per week- Precigen is a dedicated commercial and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target... ...infectious diseases.Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and...CommercialWork at office
- ...Title: Supply Chain Manager for Clinical Trial medications AstraZeneca... ...the research, development, manufacture and marketing of prescription... ...drugs can be scaled up for commercial manufacture. Tasks and responsibilities... ...planning. • Work within GMP Quality Management Systems...CommercialRemote workFlexible hours
$269k - $328.9k
...rigorous process of development, manufacturing, testing and delivery.... ...from early development through commercialization.The Executive Director will... ...regulations (e.g., ISEC, GMP, HSE), and manage regulatory... ...Operations for GMP manufacturing of clinical and commercial cell therapy...CommercialFull timeWork at office3 days per week- AstraZeneca GmbH seeks a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC). You will shape end... ...indication, lead global commercial initiatives, and align with clinical, data science, and market access teams. You will influence...Commercial
$93.1k - $232.8k
...bring breakthrough treatments to patients faster.Drive global clinical trials from first site activation to final patient visit—own the... ...is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and...CommercialFull timeContract workPart timeWork at officeImmediate startWorldwide- ...change the course of medicine and bring big new ideas to life.As Commercial Leadership within Oncology, our ability to effectively and... ...mind of our customers (HCPs, patients, payers); and translating clinical and economic benefits into a compelling message platform....CommercialHourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week
$231.99k - $347.98k
...to late-stage development and commercialization. We are rapidly progressing a broad... ...across Research & Development, Clinical, Medical, Market Access, Regulatory, Manufacturing, Supply, and country teams. You... .... Direct cell therapy, gene therapy, or advanced therapy experience...CommercialHourly payFull timeTemporary work$267.91k - $401.87k
...chain from discovery through to late-stage development and commercialization. We are rapidly progressing a broad pipeline of cell therapies... ...intelligence—partnering with Therapeutic Areas on clinical strategy, collaborating with in-market commercial and medical...CommercialFull timeTemporary workWork at officeFlexible hours3 days per week- ..., Quality Assurance, Quality Control and Commercial groups as necessary to attain project goals... ...post-graduate experience in a research, clinical, or product development environment.... ...preferred. Experience in ISO9001/ISO13485, GMP, and/or Design Control are highly desired...Commercial
$231.99k - $347.98k
.... Through relentless innovation and our diverse portfolio, we are setting new standards for what science can achieve in the clinic and commercial marketplace alike.AstraZeneca is more than one of the world’s leading biopharmaceutical companies—we are united in our dedication...CommercialFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...emphasized that the Logistics Specialist role is highly detail-... ....g., quality control, manufacturing operators with SOP... ...partnering daily with Clinical Operations, Patient... ...biopharma clinical or commercial logistics, supply... ...knowledge of GDP, GxP, and GMP requirements,...CommercialFlexible hours
$45.35 per hour
...specimens and proper request forms and routine specimens sent to commercial labs for analysis; performs and/or arranges for lab work in... ...Basic Cardiac Life Support (BLS). Minimum two (2) years of clinical experience in the last three (3) years as a Registered Nurse....CommercialContract workReliefImmediate start- ...Hospital Insurance Follow-Up Specialist District Partners is engaged with a well-established... ...balance Communicate with commercial, Medicare, Medicaid, and managed care payers... ...additional review from coding, billing, clinical, or other internal teams Maintain...Commercial
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