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$135k - $185k
...modality, such as: ~ Monoclonal antibodies (mAbs) ~ Fill–finish (aseptic or non-aseptic) ~ Advanced therapy medicinal products (ATMPs), including cell and gene therapies ~ mRNA ~ Vaccines ~ Active pharmaceutical ingredients (API) ~ Oral solid dosage (OSD) ~...SuggestedFull timeFor contractorsCasual workFlexible hours- ...defend all CMC sections of INDs and other regulatory submissions Lead interactions with FDA and other agencies. Translate evolving ATMP guidance into actionable, risk-based internal standards. Build & Coach a High-Performance Team Hire and manage scientists/...Suggested
- ...experience of overall experience is required. ~2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products. ~ Familiarity with Quality by Design (QbD) principles and their...SuggestedFull timeLocal area
Johnson & Johnson
Malvern, PA3 days ago $117k - $157k
...Requirements Substantial process design and operations experience in pharmaceutical facilities, which should include Biologic, Vaccine, and/or ATMP products. Degree in natural sciences and/or engineering discipline (Biotechnology, Biology, Biochemistry, Process, Mechanical...Suggested- ...Driver – Texas (Statewide Opportunities) $2.50 per mile + weight bonuses + tips Saber Tech Logistics is onboarding drivers for ATMP-core Courier , a new enterprise courier platform launching across Texas. We are actively building driver demand ahead of our full...SuggestedFor contractors
- ...DRTS) 3.3 Network Systems Administrator in support of the Warfighter Training Readiness Solution (W-TRS) Contract, formally known as ATMP. DRTS program is the enabler of range modernization for tactical vehicle training. DRTS provides the infrastructure and...SuggestedContract workDay shift
- ...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
- ...isoneofthefastestgrowingcompaniesintheSemiconductorindustry.WeareworldwidetechnicalleadersinIntegratedPowerSemiconductorsandSystemsPowerdeliveryarchitectures.AtMPS,wecultivatecreativity,arepassionateaboutsustainability,andarecommittedtoprovidingleading-edgeproductsandinnovationtoourcustomers....SuggestedHome office
$201k - $268k
...processes, and equipment meet applicable regulatory and industry standards (FDA 21 CFR 1271, 820, 210/211, AATB, ISO 13485, cGMPs for ATMPs, etc.). Oversees validation, qualification, and change control activities in alignment with Quality systems. Partners closely with...SuggestedContract workLocal areaFlexible hours- ...or biologics. Proven success in developing and executing global regulatory CMC strategies for advanced therapy medicinal products (ATMPs) or biologics. Strong track record of leading CMC submissions (IND/CTA through BLA/MAA) for gene therapy or biologics. In‑depth understanding...SuggestedTemporary work
- ...Experience with line management and development of direct reports. Strong preference for experience in advanced therapy medicinal products (ATMPs) and radioligand therapy / radiodiagnostics. Required Specialized/Technical Skills: Strong working knowledge of FDA regulations,...Suggested
$130k - $150k
...facilitate stakeholder engagement, and provide public transparency throughout all phases of the Airfield and Terminal Modernization Program (ATMP). Responsibilities Monitors and reports on issues, complaints, and project activities. Provides strategic communications support....SuggestedFull timeFor contractorsLocal areaMonday to FridayFlexible 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...SuggestedFull timeContract workFor contractorsFor subcontractor
- ...Experience: ~8+ years of experience in biopharmaceutical manufacturing or technical operations, with at least 4 years in cell therapy or ATMP manufacturing. ~ Proven experience leading CMO operations for commercial or late-stage products. ~ Demonstrated success managing...SuggestedContract work
Genetix Biotherapeutics
Somerville, MA26 days ago - ...cell processing, formulation, fill-finish, and cryopreservation. Ensure manufacturing activities comply with FDA, EU, and ICH cGMP/ATMP standards. Lead execution, review, and correction of Batch Records (BRs). Coordinate production scheduling, capacity planning,...SuggestedFull timeRemote work
Planet Pharma
Germantown, MD18 days ago $132.69k - $203.4k
...Regulatory Guidelines: Familiarity with ICH Q7, Q9, and Q10, and applicable FDA/EU regulations for Advanced Therapy Medicinal Products (ATMPs). ~Industry Experience: Hands-on experience in cell therapy, aseptic processing, biologics, or API/drug product manufacturing...Full timeContract workWork at officeLocal areaMonday to FridayFlexible hours- ...advances, regulatory trends, and industry best practices across small molecules, biologics, and advanced therapy medicinal products (ATMPs). Adhere to Sia LBG quality standards and core values in all client deliverables and engagements, ensuring the highest level of...Full timeFor subcontractorH1bWork at officeWorldwideVisa sponsorshipWork visaFlexible hours3 days per week
$360k - $400k
...familiarity with Orphan Drug (US/EU), Rare Pediatric, Regenerative Medicine Advanced Therapy (RMAT), Advanced Therapy Medicinal Product (ATMP) and PRIME designations. Ensures all outgoing FDA/EMA submissions are complete, accurate, timely and in compliance with current...Temporary workLocal areaShift work- ...hardware maintenance trainers supporting the AATS. Coordinate with War Fighter Focus Contract (WFFC)/Army TADSS Maintenance Plan (ATMP) simulator maintenance contractor daily to track simulator maintenance status and service requests. Coordinate with unit course managers...Contract workFor contractorsTraineeshipWork at office
$145.9k - $234.2k
...with life cycle management, including GMP compliance and training.* Familiarity with expedited regulatory pathways, EU GMP Annex1, ATMP/CGT guidances, and relevant ICH (e.g. Q8, Q9, Q10, Q12, Q13).* Expertise with mRNA, lipid nanoparticle formulation, or other nucleic...Full timeWorldwide- ...Required knowledge/experience: · Minimum 3 years of regulatory CMC experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs). Experience in Gene Therapy Medicinal products is a plus. · Successful experience in writing and reviewing Module 3/QOS sections...Remote work
$94k - $174.6k
...Provide technical assessment, oversight, and approval of CCS and sterility assurance-related systems, ensuring alignment with cGMP, ATMP GMPs, USP, EP, and JP standards. Collaborate with manufacturing, quality, and facility teams to develop unified strategies for contamination...Local areaRemote workRelocation packageGenentech
Hillsboro, OR20 days ago$95k - $120k
...is a global leader in advanced containment and automation technologies for the Radiopharma , Pharma , and Cell & Gene Therapy (ATMP) industries. Our innovative solutions include shielded isolators, aseptic filling systems, and modular cleanroom technologies that support...Work at officeRemote workAfternoon shift- ...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...For contractorsWork experience placementWork at office
HDR
Los Angeles, CA3 days ago $160k - $240k
...group activities. Key Responsibilities Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs). Provide operational oversight of, and troubleshooting support...Full timeContract workSummer workWork at officeRemote workFlexible hoursShift work2 days per weekVertex Pharmaceuticals Incorporated
Boston, MA14 hours ago- ...operations, ideally autologous cell therapy experience.Solid experience in equipment and facility qualification and validation for ATMP CMOsOffice and cleanroom must be able to comply with cleanroom gowning requirements at CMOMust be comfortable moving about inside the...Full timeContract workSummer workWork at officeRemote work2 days per week
Vertex Pharmaceuticals (San Diego) LLC
Boston, MA14 hours ago $250k - $325k
...Experience with prelaunch or commercialization activities in a Medical Affairs capacity. Experience with complex cell or gene therapy (ATMP) products. Work Environment and Physical Demands Professional office (San Diego) or remote work environment. Prolonged...Full timeWork at officeLocal areaRemote workCapricor Therapeutics, Inc.
San Diego, CA14 hours ago
