DIRECTOR DRUG SUBSTANCE PROCESS jobs in SAN FRANCISCO CA LOS, United Kingdom

on X (formerly Twitter) and LinkedIn. About the role: Allogene Therapeutics is seeking a head of Drug Substance Process...-stage CAR-T drug substance processes across Allogene’s pipeline. We encourage applicants who believe they have the skills...

from process chemistry development through to drug substance manufacturing. Requirements What will you be doing? Responsible... for leading all small molecule drug substance development and manufacturing Management of drug substance process chemistry...

scientists and is responsible for the process development and supply of small molecule drug substance (API) for all phases... (SME) internally for troubleshooting process chemistry issues Review and approve batch documents for drug substance manufacturing...

and/or at Outside Testing Labs (OTL's) associated with the manufacture of drug substance and drug product for Vaxart's product platform... employees Participates in all regulatory audits and inspections. Ensures release testing of drug substance and drug product...

the development of batch records, validation protocols Oversee the drug substance, drug product, packaging/labeling... with FDA inspections and interaction with FDA Experience in small molecule drug substance and solid oral dose production...

substance & drug product. Current and strong working knowledge of 21 CFR Parts 210-211 and 11; EU cGMP/GLPs; and ICH quality... products. Support PPQ activities which will include review of process validation protocols/reports, risk assessments, method...

portfolio including process development and manufacture of regulatory starting materials (RSMs) and support production of Drug... Substance (DS) for clinical trial materials, and establishment of associated Control Strategy for RSMs and DS to support NDA/MAA...

at CROs/CMOs required Extensive technical/functional/development expertise in Drug Substance, Drug Product, Drug Delivery..., Analytical or Regulatory Drug Substance and Drug Product GMP experience required Responsible to lead direct report(s) through...

Development will be required. The Referral Center Manager shall provide assistance to the Director in managing the clinic in...'s patient record review process. The Referral Center Manager will assist under/uninsured individuals in the community diagnosed...