teams and influencing senior stakeholders without direct reporting authority Knowledge of biologics, plasma-derived...
leadership for the Spine Hardware & Biologics portfolio, with a primary focus on portfolio phase-in/phase-out (lifecycle... history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional...
for drugs, biologics, blood products, and medical devices. Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files... regulatory affairs. Medical product development lifecycle. Drugs, biologics and/or medical devices. Regulatory submissions...
and interpret diagrams, drawings, P&IDs, electrical schematics, and other technical documentation. Ability to self-direct daily... in biologics or sterile drug product manufacturing. Experience with data historian, SCADA, or visualization platform configuration...
one or more of the areas including Field Reimbursement or Specialty or Biologics Field Sales (HCP administered or Specialty Pharmacy... one or more of the areas including Field Reimbursement or Specialty or Biologics Field Sales (HCP administered or Specialty Pharmacy...
control activities for biologics manufacturing, with a strong focus on testing, method development, and robust quality systems... activities, including product testing, stability control, and analytical method development for biologics. Perform detailed...
, biologics, ADCs, bi-specifics, cell therapies, and other emerging platforms). Critically evaluate biochemical and cellular... small molecules, biologics, ADCs, bi-specifics, T cell engagers, cell and gene therapies, and RNA based therapeutics...
and procedures. Responsible for balancing direct, specialized clinical patient care with meticulous data tracking, regulatory..., and stores trial investigational products alongside the Clinical Pharmacy;manage active inventories of study-specific biologics...
at Vertex. This role will support quality activities associated within the Small Molecule, Biologics, Device CMC Compliance team... / CAPA development in at least one of the following areas: device, biologics or small molecule. Preferred Qualifications...
genomics, ex vivo, and/or in vivo immunology approaches. Prior people leadership, direct line management, or significant... therapeutic modalities, including small molecules, biologics, and/or cell‑based therapies. Experience integrating human biology...