, and environmental, health, and safety legislations. This position is part of the Manufacturing Operations group within the larger..., and ensure sustainability. May represent manufacturing on one or more cross-functional Development or Commercial CMC teams...
of submission documents for CMC. In this role you will independently manage and draft extended characterization documents... for our Preclinical Development and Protein Chemistry Sciences group. You will also update and maintain document templates and internal...
. Regularly contribute at department and project team level and represent the group on multidisciplinary teams. May present... use, such as JMP Experience with GMP manufacturing Familiarity with CMC team function Experience with technology transfer...
Overview: Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company... as the subject matter expert in CMC and non-clinical (pre-clinical)/clinical (humoral and cell-mediated) analytical methods...
SUMMARY/JOB PURPOSE: The Scientist IV, Analytical Development, Biologics CMC will independently conduct laboratory... experiments with limited supervision to build in-house R&D testing capabilities in support of CMC analytical development projects...
of biologics (therapeutic proteins, antibodies, bispecifics, ADCs, etc) to advance CMC development and manufacturing for pre-IND..., and technical quality of our CMC activities. The incumbent should have excellent hands-on technical abilities...
about. Job Summary The Senior CMC Project Manager leads project execution after deal closure. Responsible for directing, leading... all projects at any stage through mapping resource across projects. In this role, the Senior CMC Project Manager is the key...
) organization within Analytical Development and Operations (ADO), based at our headquarters in Foster City, CA. The group... is responsible for CMC analytical activities related to the development of Gilead’s small molecule drug substances and drug products...
planning; transfer pricing; CMC variation strategy; product launches; manufacturing tech transfers; and scientific or technical...: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical...
collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any.... The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain...