Technical Manager (Biologics)
. Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development. CMC...
. Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development. CMC...
. Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities, identify potential...
. Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development. CMC...
, or a related scientific/technical discipline. Minimum of 3 years? hands-on Regulatory/CMC authoring experience (initial...
. Review and approve NPI-related analytical test method transfers and/or validation. Collaborate with CMC QA, R&D, S&T...
. Review and approve NPI-related analytical test method transfers and/or validation. Collaborate with CMC QA, R&D, S&T...
: Maintenance of, and variations to, CMC Dossier for assigned products. Support and manage all regulatory requests impacting site...
-marketing, with a strong understanding of regulatory requirements related to CMC aspects for drug development, product...
supporting CMC teams preferred Education: B.S +10 years experience, MSc + 8 years experience, or PhD + 3-5 years experience...
in clinical research or laboratory services - Knowledge of EMEA CMC Drug Development market and Biopharma customers Preferred...