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$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...SuggestedFull timeTemporary workLocal area- ...Demonstrated success managing client relationships, SOW scope management, revenue targets, and multi-project service portfolios in the ATMP/CGT sector.Technical Breadth: Deep knowledge of process/analytical development, vector biomanufacturing, cell processing, and...SuggestedContract work
$133.2k - $172.37k
...with Fours Years' experiencePreferred QualificationsDegree in a scientific disciplineExperience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control...SuggestedFull timeContract workFor contractorsWork at officeLocal areaRemote workRelocationFlexible hours$135k - $185k
...manufacturing modality, such as:Monoclonal antibodies (mAbs)Fill-finish (aseptic or non-aseptic)Advanced therapy medicinal products (ATMPs), including cell and gene therapiesmRNAVaccinesActive pharmaceutical ingredients (API)Oral solid dosage (OSD)Exposure to additional...SuggestedFor contractorsCasual workFlexible hours- ...Demonstrated success managing client relationships, SOW scope management, revenue targets, and multi-project service portfolios in the ATMP/CGT sector. Technical Breadth: Deep knowledge of process/analytical development, vector biomanufacturing, cell processing, and...SuggestedContract work
$143.23k - $185.35k
...global CMC regulatory strategies aligned with program objectives, business timelines, and evolving health authority expectations for ATMP / CAR-T products.Help ensure global harmonization and consistency of Module 3 content across applications, regions, and lifecycle...SuggestedFull timeFor contractorsWork at officeLocal areaRemote workRelocationFlexible hoursShift work- ...things possible not only in your community, but around the world. HDR is providing PM/CM services for the Los Angeles World Airports ATMP Landside Improvements Project. The project will deliver critical improvements to the roadways, streets, and thoroughfares in and...SuggestedContract workTemporary workFor contractorsWork at office
- ...Dental, Vision, Life Insurance, Disability, Pre-Tax Savings Accounts, and ancillary benefits 100% Employer Paid Basic Life Insurance &atmp; Employee Assistance Program Generous Paid Time Off plan and 6 paid holidays annually Employee Referral Bonuses 401K Retirement Plan...SuggestedDaily paidFull timeShift work
- ...technical knowledge of aseptic processing and cell processing techniques, as well as applicable regulatory frameworks including cGMP and ATMP requirements and biosafety expectations.Support future expansion and site-readiness initiatives, including area readiness, equipment...SuggestedFull timeLocal areaImmediate start
$213.06k - $260.41k
...matrix environment and lead with curiosity and influence across functional and organizational linesExperience with IND or BLA filing of ATMP/biologic products.Experience with commercial QC activities#LI-HybridEEOC Statement: Intellia believes in a diverse environment, and...SuggestedFull timeRemote workShift work$124.07k - $186.1k
..., network planning, manufacturing planning, capacity planning, or S&OP / S&OE leadership. Experience in Cell Therapy, Gene Therapy, ATMPs, autologous or patient-specific supply chains strongly preferred. Experience with CGT orchestration tools, advanced planning tools,...SuggestedHourly payFull timeTemporary workLocal areaShift work$135k - $185k
...manufacturing modality, such as: Monoclonal antibodies (mAbs) Fill-finish (aseptic or non-aseptic) Advanced therapy medicinal products (ATMPs), including cell and gene therapies mRNA Active pharmaceutical ingredients (API) Exposure to additional modalities, platforms, or...SuggestedFor contractorsCasual workFlexible hours$75k - $100k
...environment with exposure to production scheduling, supply chain planning, or GMP manufacturing; Experience working in CDMO biotech or ATMP (Advanced Therapy Medicinal Products). Particularly cell and gene therapy, is highly desirable. Proficiency with ERP systems (SAP...SuggestedContract workShift work- ..., and stability.Provide subject matter expertise on container closure systems for injectable drug products, including biologics and ATMPs.Execute and support studies evaluating container closure integrity, sealing performance, and system robustness for injectable packaging...SuggestedRelocation
$100k - $120k
...development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based...SuggestedContract workWorldwide$191k - $202k
...Expertise: Strong preference for experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs). Regulatory Compliance & Inspections: Expert understanding and practical application of global regulatory guidelines (FDA, EMA,...Local area$65 - $110 per hour
...abilities. Ability to mentor/train junior staff and manage contractors. Experience supporting commercial biologics, gene therapy, ATMP, or monoclonal antibody GMP manufacturing. Experience in a start-up environment and pre-clinical through commercial GMP...Contract workTemporary workFor contractorsWork at officeWork from homeActalent
Cumnock, NC3 days ago$210k - $260k
...negotiate with regulatory authorities. Desired Skills: Deep understanding of FDA regulations for Advanced Therapy Medicinal Products (ATMPs). Strong strategic thinking and ability to balance short-term needs with long-term vision. Exceptional communication and...Temporary workLocal area- ...experience. Personally source and engage exceptional talent, including passive candidates in highly competitive areas such as cell therapy, ATMPs, CMC, clinical development, regulatory, quality, manufacturing and other specialized life science disciplines. Bring strong...Remote work
- ...on inventory strategy, yields and cost impacts on product P&L, forecasting, and cross-functional decision support across wafers and ATMP operations.THE PERSON: The ideal candidate should have a bias for action, high sense of teamwork, and ability to speak up and make recommendations...
- ...relevant experience is required.Required:· 2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products.· Demonstrated expertise in CQA assessment and developing control...Full timeLocal area
$71.75k - $107.62k
...military/apprenticeship training; or related field a plus. Experience: 6-10+ years in maintenance within GMP biopharma or cell therapy/ATMP manufacturing, including cleanroom facilities and regulated utilities. GMP Knowledge: Strong command of cGMP, GDP, change control,...Hourly payTemporary workApprenticeshipLocal area- ...processes preferred.TECHNICAL SKILLS / CORE COMPETENCIESDeep expertise in GMP regulations applicable to QC laboratories supporting ATMPs.Strong knowledge of analytical techniques (e.g. q/rt/ddPCR, flow cytometry, ELISA, cell-based assays, microbiological methods) and their...
$140.8k - $211.2k
...verbal, and scientific communication skillsExperience in cell and gene therapy, biologics, or advanced therapy medicinal products (ATMPs)Familiarity with rapid and alternative microbiological methods and implementation strategiesParticipation in industry working groups...Full timeSummer workFlexible hours- ...Electronics Technician Maintenance III in support of the Warfighter Training Readiness Solution (W-TRS) Contract, formally known as ATMP. W-TRS program purpose is to provide ongoing Operations and Maintenance (O&M) and training-related services in support of U.S. Army...Contract work
- ...years’ experience in Biopharmaceutical quality assurance with practical knowledge in quality systems, FDA, cGMPs, cGTPs, cGLPs and ATMP regulations At least 5 years’ direct QA experience in cell and gene therapy or biologics manufacturing. Prior experience with...
Gift of Life Marrow Registry Inc
Boca Raton, FL21 days ago - ...preferred. Minimum of 12 years of progressive experience in GMP facility, equipment, or process delivery within pharmaceutical, biotech, ATMP, medical device, or high-containment life-science environments. Minimum of 5 years leading multidisciplinary technical teams,...Work at officeRemote workFlexible hoursNight shift
Germfree Laboratories Inc
Ormond Beach, FL16 days ago $199.22k - $284.6k
...experience in development, manufacture, or commercialization of cell therapy, gene modified cell therapy, regenerative medicine products, ATMPs, CAR-T, TCR-T, stem cell therapies, or related advanced therapeutic modalities.Strong understanding of allogeneic manufacturing...Work at officeWork from homeWorldwide2 days per week3 days per week- ...Medpace also offers certificate programs in medical device, rare disease, infectious disease, advanced therapeutic medicinal products (ATMP), and COVID-19. We are seeking applicants with experience in the following indications: Solid Tumor Breast, Ovarian,...Contract workWork at officeRemote workWork from homeHome officeFlexible hours
- ...on the Mobile Close Combat Tactical Trainer (MCCTT) on the Army Training Aids, Devices, Simulators, and Simulations (TADSS) Program (ATMP). ATMP is the next worldwide, integrated training systems maintenance and sustainment contract for the Army's TADSS,...Contract workPart timeFor subcontractorWork at officeLocal areaWorldwideMonday to FridayWeekend work
Cymstar Services LLC
Hattiesburg, MS5 days ago
