- Amgen (Cambridge, MA)
- …of patients while transforming your career. Process Development Senior Scientist, Late-Stage Drug Product Development **What you will do** Let's do this. Let's ... work as part of a group that is responsible for late stage drug product formulation and process development for biologics modalities (eg monoclonal antibodies,… more
- Penn Medicine (Philadelphia, PA)
- …and dispenses medications using appropriate techniques to ensure positive outcomes of drug therapies and compliance with regulatory requirements and the ... Pharmacy Specialists both participate in and lead quality improvement efforts, including drug use evaluations as well as clinical research projects in their… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …**Key Responsibilities** The Principal Scientist will collaborate across BMS sites with Drug Product, Analytical, API, Quality, and Regulatory functions to ... personal lives. Read more: careers.bms.com/working-with-us . **Business Unit Summary:** Our Drug Product Development team is committed to CMC design, development,… more
- Insight Global (East Whiteland, PA)
- …This role is critical in selecting and developing packaging solutions that ensure drug product safety, stability, and regulatory compliance from early clinical ... and stability requirements. * Collaborate with cross-functional teams including Drug Product Development (DPD), Device, Clinical Supply, MSAT, Commercialization, and… more
- J&J Family of Companies (Spring House, PA)
- …for assigned projects. + Communicate effectively with stakeholders, including regulatory authorities, leveraging drug development experience. + Provide ... by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …Manufacturing Sciences (MS) Department specifically in Cell Culture and Purification ( Drug Substance) manufacturing processes. This role is responsible for MS day ... SOPs and production records. + Provide support to audits, change controls, and regulatory submissions, as needed. + May perform other duties as assigned. **What you… more
- AbbVie (South San Francisco, CA)
- …process performance and 2) develop robust, phase-appropriate cell culture processes for drug substance GMP production to enable human clinical studies and eventual ... and review technical reports, GMP campaign summary reports and relevant sections in regulatory filings + Actively seek out opportunities to optimize our platform or… more
- Honeywell (Buffalo, NY)
- …customer relationships, identifying unmet industry needs, and navigating the regulatory environment. This role will involve working with global, cross-functional ... (IP) related to inhaled applications, ensuring Honeywell's competitive position. * Regulatory & Industry Engagement: Work closely with customers, industry partners,… more
- Amgen (Thousand Oaks, CA)
- …lives of patients while transforming your career. **Process Development Associate - Pre-Pivotal Drug Product** **What you will do** Let's do this! Let's change the ... and clinical development programs. In doing so they will contribute to regulatory filings and to Amgen's intellectual property. In addition, you will have… more
- Kelly Services (South San Francisco, CA)
- …manufacturing relationships. + Track record of authoring, reviewing, and supporting regulatory documentation for global drug development. + Outstanding ... Kelly(R) Science & Clinical is seeking an Associate Director/Director of Drug Substance Manufacturing for a direct hire opportunity with a leading biopharmaceutical… more