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
- Scorpion Therapeutics in Maryland is hiring a GMP Gene Manufacturing Associate I/II to produce clinical and commercial adenovector products in a cGMP setting. You will assemble raw materials, execute Master Batch Records, and support SOP development in a cross-functional...Commercial
- 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
- Role: GMP Gene Manufacturing Associate I/II responsible for producing clinical and commercial adenovector products in a cGMP setting. Core responsibilities assembling raw materials executing Master Batch Records supporting SOP development managing deviations ensuring equipment...CommercialCasual 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
- Scorpion Therapeutics is seeking a Process Engineer to support gene therapy Drug Substance manufacturing from clinical to commercial stages. You will drive technical excellence in manufacturing, process transfer, validation, and facility startup for Adenovector products...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
- Miltenyi Biotec is seeking a Manufacturing Operator to join our cGMP biologics production team in Gaithersburg, MD. You will follow SOPs, complete... ...and maintain cleanroom standards. The role requires 1 year of GMP experience, attention to documentation, and collaboration with...
- 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
$144k - $212k
...therapies designed to be manufactured at scale, inventoried,... ...an entirely new clinical supply playbook.... ...biologics, vaccines, gene therapies, or other inventory... ...registration and potential commercialization. Influence cross-... ...ICH-GCP, FDA, EMA, GDP, GMP, and applicable...CommercialTemporary workWorldwide- 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
$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...$50k - $62k
Piper Companies is seeking a Manufacturing Associate to support a leading... ...SOPs, work instructions, and GMP documentation requirements... ...Process Sampling, Cryopreserved, Clinical, Allstream, Filtration, pH,... ...Organic Chemistry, Manufacturing Specialist, UF/DF, Scale-down, Bioburden...$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$112.3k - $168.46k
...supporting the development of clinical manufacturing processes for allogeneic CAR... ..., including optimization of gene editing, culture expansion,... ...transfer to clinical and commercial manufacturing sites. The team... ...transduction techniques desirable. GMP experience preferred....CommercialFull timeTemporary workWorldwideWeekend work$249.83k - $374.74k
...join! Who We Are In the Respiratory Translational Sciences and Clinical Development (TSCD) team, we are investigating the drivers of... ...Translational Medicine, Early and Late‑stage Clinical Development and Commercial colleagues across functional teams. Closely follow medical...CommercialTemporary work$112.3k - $168.46k
...medicines from discovery through clinical and commercial development.Position... ...an emphasis on autologous manufacturing processes. The successful candidate... ...selection, activation, gene modification, expansion,... ...transfer to internal and external GMP manufacturing sites,...CommercialFull timeTemporary workWorldwide- ...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. Novel... ...FDA/EMA guidance relevant to gene and cell therapy; experience...CommercialHourly payWork at officeFlexible hours3 days per week
$122.31k - $183.47k
...our cell therapy Global Manufacturing Science and Technology... ...transfer for pivotal clinical manufacturing, process... ...to enable commercialization and lifecycle management... ...extensive background in GMP manufacturing operations... ...in a fast‑paced cell & gene therapy field. Salary...CommercialTemporary work- ...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
- Role Process Engineer supporting gene therapy Drug Substance manufacturing from clinical to commercial stages. Objectives: ensure technical excellence in manufacturing, process transfer, validation, and facility startup for Adenovector products. Responsibilities provide...Commercial
- 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
$60k - $75k
...Sciences is seeking a skilled and motivated Manufacturing Associate II (Downstream) to join a... ...manufacturing of drug product following GMP guidelines Perform buffer and media preparation... ..., manufacturing, MFG, manufacturing specialist, biopharmaceutical associate, bioprocess...$50k - $62k
A leading biopharmaceutical organization is seeking a Manufacturing Associate in Gaithersburg, MD, to support bioprocessing activities. The... ...operations, maintenance of bioprocess equipment, and adherence to GMP standards. The ideal candidate will have a bachelor’s degree in...$50k - $61k
Piper Companies is seeking a Manufacturing Associate to support a leading biopharmaceutical organization out of the Gaithersburg, MD area. The... ...equipment Follow batch records, SOPs, work instructions, and GMP documentation requirements Qualifications of the Manufacturing...- ...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
- 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
$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$201.58k - $237.21k
...regulatory strategies that support clinical trials, health authority... ...management for cell and gene therapy products. Provide... ...justifications to support manufacturing operations and regulatory submissions... ...late-stage development and commercial launch experience is...CommercialFull timeWork at office- ..., 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
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