Ionis PharmaceuticalsNASDAQ: IONS: Discovers and develops RNA-targeted medicines for serious diseases.
3+ YOEBachelor's degree in a science-related field, 3+ years quality assurance experience in pharmaceutical/biotech, strong knowledge of GxP/GMP and quality systems, familiarity with AI in GxP desirable, strong communication and problem-solving.
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global pharmaceutical developing and manufacturing medicines.
3+ YOEBachelor's degree in life sciences, chemistry, or related field; 3+ years in GxP biopharmaceutical or API manufacturing; 2+ years in regulated-environment quality assurance.
Validation - Engineer III / Lead Engineer - Project Farma
South San Francisco or Pasadena or San Diego or Portland or California or Texas or Colorado
FieldFull Time
PerkinElmer: Provides analytical instruments and laboratory services for scientific industries.
2+ YOEBachelor's in life science/engineering or equivalent, 2+ years consulting/engineering experience, CQV/GxP and validation expertise, protocol and SOP authoring, project controls familiarity, and willingness to travel extensively for client assignments.
Earned Value Analysis (EVA), GxP, CQV, Computer System Validation
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
8+ YOEBachelor's in a related field, 8+ years in clinical/GMP labs, 3+ years supporting IVD development, regulatory knowledge (GxP, Part 11, ICH, ISO, CLIA/CAP, IVDR, QSR), molecular biology familiarity, statistical understanding, strong communication.
Codera: Provides end-to-end drug development services for biotechnology companies.
5+ YOEBachelor's degree; 5+ years in pharmaceutical supply management and logistics; experience with clinical supply; proficient in GxP; strong organizational and budgeting skills; proficient in Excel.
Arrowhead PharmaceuticalsNASDAQ: ARWR: Develops RNAi medicines to treat genetic and intractable diseases.
8+ YOEBachelor's degree with 12+ years or master's degree with 8+ years of relevant GxP bioanalytical experience; expertise in method development, validation, regulated analysis, and analytical platforms required.
LC-MS/MS, LC-FL, hybrid assays, immunoassays, Good Documentation Practices (GDP)
Viking TherapeuticsNASDAQ: VKTX: Develops therapies for metabolic and endocrine disorders.
3+ YOE3+ years QA experience in a GMP environment; experience implementing Veeva Vault/Basics, knowledge of GxP and 21 CFR Part 11, strong communication and process-mapping skills.
Veeva Vault, Veeva Basics, Veeva Vault Quality Suite
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
10+ YOE10+ years leading enterprise laboratory technology and teams; experience with cyber security, ITSM/ITIL, GxP/SOX compliance, budget and vendor management, product owner or demand-shaping experience.
Artiva BiotherapeuticsNASDAQ: ARTV: Develops allogeneic natural killer cell-based therapies for various diseases.
5+ YOEParalegal certification or J.D.; 5+ years in biotech/pharma/life sciences; experience with commercial contracts and clinical trial agreements; CLM tool proficiency; GxP/GMP understanding; strong organization and communication.
Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
2+ YOERequires a BS/BA with 2–4 years or AA with 3–5 years in GXP-compliant pharmaceutical or biotech manufacturing, 2+ years of CMMS experience, MS Office proficiency, and strong communication skills.
Computerized Maintenance Management System (CMMS), Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Deal Manager, Contract Manager
Carlsbad or Chicago or Raleigh or Durham or Greensboro or Pittsboro
$100k-$140k/yrHybridFull Time
Gilero: Contract medical device design, development, and manufacturing services.
5+ YOEBachelor's degree,5+ years relevant experience,knowledge of FDA 21 CFR 820/ISO 13485/ISO 14971,cGMP,GxP; experience with electromechanical devices, audits, risk management, and verification/validation.
Tr1X: Develops engineered T-cell therapies for treating autoimmune diseases.
12+ YOE5+ MgmtBS in a scientific discipline,12+ years pharma/biotech quality experience with biologics/cellular therapy,5+ years management,experience with FDA/ICH/GxP,inspection hosting,project planning,and Microsoft Office proficiency.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Catalent: Global provider of drug development and manufacturing solutions.
High school diploma required (BS/BA desirable). Experience in GxP manufacturing preferred. Detail-oriented, organized, able to work independently and with teams, and able to perform batch record reviews and support GMP manufacturing.
CBRENYSE: CBRE: Provides global commercial real estate services and investment management.
8+ YOE8+ years experience in monitoring or certification roles in regulated industries (GxP, ISO, ASTM). Must perform installations, calibrations (IndySoft), training, maintain ticketing/workflow, strong communication, problem-solving, and computer aptitude.
IndySoft, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft SharePoint
Senior Specialist 2, Information Technology Technical Support & Maintenance
San Diego, California, United States
OnsiteFull Time
HalozymeNASDAQ: HALO: Develops drug delivery technologies and therapeutic products.
8+ YOE8+ years IT experience with 2+ years supporting NetSuite; experience with Workato, Zone, RF-SMART; SOX and GxP familiarity; troubleshooting, documentation, and user training skills; NetSuite Administrator or SuiteFoundation preferred; SuiteScript/JavaScript preferred.
Milpitas or San Diego or United States or Puerto Rico or South America
$154k-$247k/yrOnsiteFull Time
BDNYSE: BDX: Manufactures medical devices, surgical instruments, and pharmacy automation systems.
10+ YOE5+ MgmtBachelor's degree, 10+ years corporate facilities management in multi-site environments, 5+ years supervisory experience, strong building systems and project management skills, AutoCAD proficiency, GxP experience preferred, travel up to 30%.
ErascaNASDAQ: ERAS: Developing precision oncology medicines to treat cancer patients.
8+ YOEBachelor of Science or equivalent required; advanced degree preferred. Requires 8–10 years in GxP pharmaceutical environments, including at least 8 years of GMP QA, solid oral dosage and biologics manufacturing, and FDA inspection experience.
electronic document management systems, Quality Management System software platforms
Travere TherapeuticsNASDAQ: TVTX: Developing and selling therapies for rare kidney diseases.
8+ YOE8+ years clinical supply chain experience in biotech/pharma/CRO, Bachelor's in biomedical/life science/supply chain (or equivalent), GxP/GCP/GMP/ICH knowledge, IRT and vendor management experience, strong communication and project management.
Interactive Response Technology (IRT), Microsoft Word, Microsoft Excel, Microsoft PowerPoint, SmartSheets
Abzena: Provides contract development and manufacturing for complex biopharmaceuticals.
5+ YOEBSc in STEM or equivalent leadership experience; 5 years systems admin/IT/automation experience (3 years in pharma/biotech); in-depth cGMP knowledge; experience with PLC/DCS, controls networking (Ethernet/IP, BACnet, DeviceNet, OPC UA), SCADA and data historian systems; familiarity with 21 CFR Part 11/GMP/GxP.
PLC, DCS, Ethernet/IP, BACnet, DeviceNet, OPC UA, Sartorius Biostat STR, Sartoirius AMBR, Cytiva AKTA Pure, Sartorius Biobrain Supervise, Sartorius BioPAT MFCS, OSI Pi, SCADA, data historian
Manufacturing Execution Systems (MES) Manager | PAS-X
Boston or Milwaukee or Dallas or Columbus or Kirkland or Cincinnati or New York City or Cleveland or Oklahoma City or Austin or Albany or Chicago or St. Petersburg or Hartford or Pittsburgh or St. Louis or Miami or Sacramento or Raleigh or Minneapolis or Mountain View or Scottsdale or San Francisco or Morristown or Denver or Philadelphia or Des Moines or Overland Park or Los Angeles or Charlotte or Walnut Creek or Carmel or Seattle or Houston or Arlington or Atlanta or Redmond or Bentonville or Beaverton or Nashville or Detroit or San Diego or United States
$80k-$294k/yrHybridFull Time
AccentureNYSE: ACN: Global provider of management consulting and technology services.
5+ YOERequires 5+ years with Körber PAS-X MES in automated life sciences manufacturing and a bachelor's degree or equivalent experience; FDA/GMP, validation, SDLC, communication, and collaboration knowledge preferred.
Körber PAS-X, Electronic Batch Records (EBR), ERP, GxP, Software Development Life Cycle (SDLC)