• Global Program Head, Neurology

    Sanofi Group (Cambridge, MA)
    …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires...in compliance with current regulations, laws, and guidance from FDA , EMeA, and CHMP, as well as with Sanofi's… more
    Sanofi Group (08/15/25)
    - Related Jobs

  • Environmental Health and Safety Specialist

    Charles River Laboratories (Cambridge, MA)
    …We have proudly worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...advise management on safety and environmental issues. Review new regulatory standards and make compliance recommendations. * Inspect the… more
    Charles River Laboratories (07/12/25)
    - Related Jobs

  • Senior/Patient Advocacy & Medical Society…

    United Therapeutics (Boston, MA)
    …+ Maintain deep understanding of external patient related guidance documents including FDA guidance on patient focused drug development (PFDD) and patient ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
    United Therapeutics (08/23/25)
    - Related Jobs

  • Microbiology Technician II

    Integra LifeSciences (Braintree, MA)
    …and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. **ESSENTIAL DUTIES AND ... or other product development studies. + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned DESIRED MINIMUM… more
    Integra LifeSciences (08/08/25)
    - Related Jobs

  • Quality Control Technician II, Analytical

    Integra LifeSciences (Boston, MA)
    …Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. + Responsible for performing ... Action/Preventive Actions (CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties as assigned. **DESIRED… more
    Integra LifeSciences (07/31/25)
    - Related Jobs

  • Principal Scientist / Principal Engineer - Peptide…

    Cambrex High Point (Waltham, MA)
    …manufacturing and tech transfer of peptide APIs. + Strong understanding of regulatory guidelines (ICH Q8/Q9/Q11, FDA /EMA expectations) and process validation. + ... a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug … more
    Cambrex High Point (08/08/25)
    - Related Jobs

  • Global Program Head, Neurology Development

    Sanofi Group (Cambridge, MA)
    …ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could ... strategy, and the network of collaborators from preclinical research to operational, regulatory and commercial functions. Success in this role requires the ability… more
    Sanofi Group (08/10/25)
    - Related Jobs

  • Process Development Senior Scientist - Synthetics…

    Amgen (Cambridge, MA)
    …method transfer, process and product development support, and GMP testing of late phase drug substances and drug products. The Scientist will work closely with a ... for synthetic molecules release testing and characterization + Collaborate closely with drug substance and drug product process development colleagues to achieve… more
    Amgen (07/20/25)
    - Related Jobs

  • Field Customer Support Specialist I 1

    Charles River Laboratories (Wilmington, MA)
    …worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ... service and compliance documentation as required by company policy, cGMP and FDA . * Responsible for resolving client testing laboratory instrument service issues.… more
    Charles River Laboratories (08/16/25)
    - Related Jobs

  • Manager, Quality Assurance

    Curia (Hopkinton, MA)
    …with cGMP. This position requires expertise in all aspects of Biologics Drug Substance manufacture, Contamination Controls, ability to work hands on, strong ... the Site Quality Head in establishing a Quality System for Biologics Drug Substance clinical and commercial manufacturing + Establish and maintain a risk-based… more
    Curia (08/14/25)
    - Related Jobs