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 workAfternoon shift
- ...Senior Manufacturing & Facilities Specialist – GMP Cell TherapyThe Senior Manufacturing & Facilities Specialist is a hands-on role that executes GMP cell... ...and compliance. Priorities will shift with the clinical schedule, so you will need to judge what matters most,...SuggestedFor contractorsShift work
- ...Precigen, Inc. in Germantown, MD, is seeking a Director of Gene Therapy Manufacturing to lead drug substance operations for clinical and commercial products. The role requires deep cGMP expertise, strategic operations leadership, and a focus on site readiness and performance...Commercial
- Miltenyi Biotec is seeking an Associate Director of Quality Operations to lead quality activities across GMP/cGMP programs, including clinical and commercial manufacturing. The role ensures regulatory readiness and strategic leadership across CA/QA functions, partnering...Commercial
- Precigen is seeking a GMP Cleaning Associate to perform professional cleaning of GMP manufacturing clinical and commercial areas. The role emphasizes safety, quality, and proactive improvement in a dynamic team setting. Qualified candidates have 1-3 years of experience...Commercial
- ...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
$45k - $55k
...an accommodation or an alternative application process. GMP Cleaning Associate Full-time Regular Associate - STAFF Germantown... ...position will perform professional cleaning of the GMP manufacturing clinical and commercial areas. Prior experience in cleaning GMP manufacturing...CommercialFull timeCasual workShift workAfternoon shift- 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
- ..., MD seeks a Director, Patient Services Strategy for US Cell & Gene Therapy to build the patient services approach from concept through... ...This role collaborates across Brand Marketing, Market Access, Commercial Operations, Medical, Digital, and launch teams to design...Commercial
- ...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... ...pharmaceutical, or cell/gene therapy development,...Commercial
- Miltenyi Biotec in Gaithersburg, MD is seeking a production operator for biologics manufacturing on a cGMP line. You will follow established procedures, execute batch production records, and adhere to gowning and cleanroom protocols to ensure product quality. The role requires...
$22.01 - $25.91 per hour
This position responsible for manufacture of biologics (LV) under cGMP conditions. Staff must... ...Follow batch record instruction and complete GMP documentation. Responsible for the... ...developments have led to cutting-edge cell and gene therapies - transformative methods that...$142.38k - $213.57k
...our growing Cell Therapy and Gene Therapy portfolio. This... ...early development through clinical and commercial readiness. The successful... ...Analytical Development, CMC, Manufacturing, Quality, Regulatory, and external... ...implementation at internal GMP sites and external CDMOs....CommercialTemporary work- 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
- ...Description Precigen is a dedicated commercial and clinical stage biopharmaceutical... ...the next generation of gene therapies using precision... ...Precigen has developed novel manufacturing processes to deliver... ...preventative maintenance within a GMP-regulated pharmaceutical...CommercialCasual workAfternoon shift
$233.59k - $350.38k
...Senior Clinical Program DirectorThe Senior Clinical Program Director is accountable for the overall delivery of the clinical program... ...clinical development plan and influence from pre-Clinical to Commercial with other core CPT members. The role will establish and monitor...CommercialHourly payTemporary workWork at officeLocal areaFlexible hours3 days per week- DEPARTMENT: Commercial Team Report to Exec. Director, Commercial... ...Biosciences is a growing Cell and Gene Therapy CRO/CDMO providing... ...analytical development, and GMP manufacturing. We partner with... ...therapies from discovery through clinical manufacturing. POSITION SUMMARY...CommercialWork at office
- ...to lead contamination control and microbiology efforts for clinical and commercial manufacturing. The role emphasizes governance of the CCS, environmental monitoring, and continuous improvement within a GMP-regulated setting. The Site Microbiologist will oversee aseptic...Commercial
- ...Overview Clinical Research Associate II US Remote Emmes Group: Building a better future... ...expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases,...CommercialWork experience placementInterim roleCasual workLocal areaRemote workWork from homeFlexible hours
$86.78k - $102.11k
...from preclinical development through GMP manufacturing and commercialization activities. This role will also be... ...recognition and forecasting for preclinical, clinical, and commercial activities. Support... ...have led to cutting-edge cell and gene therapies - transformative methods...CommercialContract work$175k - $190k
# Applicant Portal:## Job Details: Associate Director, Clinical Operations| | Associate Director, Clinical Operations || | Gaithersburg... ...,000-$190,000 || | Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is...CommercialContract workLocal area$233.59k - $350.38k
...Job Title: Senior Global Clinical Development Scientist Director Flexible to be based in Gaithersburg, MD or Barcelona Missisauga... ...input from global medical affairs, marketing companies, commercial, and other stakeholders to unlock study success. Process Improvement...CommercialHourly payTemporary workWork at officeWorldwideFlexible hours3 days per week$127k - $137k
...delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is... ..., biologics, cell & gene therapy, or CDMO environment preferred...CommercialContract workLocal area- ...the company’s GxP activities, with a primary focus on GMP operations, and cGMP readiness in support of CGT and LVV manufacturing. This position supports activities related to pre-clinical, clinical and commercial manufacturing operations in accordance with US-FDA, EU,...CommercialFull time
- ...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
$194.13k - $291.19k
...The Commercial Excellence Director is a Maryland-based role responsible for the US AZ Oncology Commercial Business Planning Frameworks... ...rolling 12-month view of relevant US Oncology business activities, clinical milestones, external events Create the vision and...CommercialTemporary workWork at officeFlexible hours3 days per week- ...design space and control strategy. Support engineering and Clinical/Commercial GMP runs at assembly sites. Review and approve batch records,... ...include development of combination products and/or associated manufacturing processes, Quality oversight or validation of device/...Commercial
- ...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
- 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...CommercialCasual workWork at officeAfternoon shift
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