- Fujifilm (College Station, TX)
- …will be required for maintenance and optimization of the process and equipment across drug substance, drug product and general operational areas. The role ... management software + Knowledge of both upstream and downstream drug substance processes including drug product...upstream and downstream drug substance processes including drug product operations. + Certified Maintenance &… more
- Genentech (South San Francisco, CA)
- …development leaders (TDLs) delivering the projects by working with functions such as drug substance, drug product , analytical development & quality control, ... medicine from the development process through clinical trials and continuing to product maturity. Our organization coordinates all aspects of the production of Roche… more
- Pfizer (Sanford, NC)
- …buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography ... various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk. + **Generates** **work… more
- Boehringer Ingelheim (Duluth, GA)
- …such as labeling supplements, DERs, EPA monthly and aggregate reports, drug product listing, establishment registration, advertising and promotional materials, ... pesticide state adverse event reporting, state licensing renewals, state product renewals, and tonnage reporting. + Contributes to the...without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must… more
- Amgen (Thousand Oaks, CA)
- …supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product . The cleaning characterization group ... + Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process. + Help develop new methods, apparatus… more
- PCI Pharma Services (Madison, WI)
- …documentation for completeness and accuracy + Participate in lot disposition and review of drug product and intermediates + Act as a first responder to quality ... corrective actions + Conduct Acceptable Quality Limit (AQL) visual inspections of drug product + Support deviation documentation, root cause investigations… more
- Bristol Myers Squibb (Madison, NJ)
- …efficiency. + Maintain accurate inventory levels, ensuring purchase orders are up to date for Drug Substance, Drug Product and Finished goods to meet demand ... and identifying and reporting any risks or constraints that may affect product availability. **Key Responsibilities:** + Supply Planning and Execution: + Develop and… more
- AbbVie (Barceloneta, PR)
- …planning and execution of Biologics and/or Toxin industrialization programs with experience in drug substance and/or drug product transfers. The program ... products. The chosen candidate is to use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Oversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug product + Ensure timely creation, review, ... and clinical and regulatory expectations + Represent QC on cross-functional product development teams, providing technical input and direction for analytical and… more
- Amgen (Washington, DC)
- …also ensure best-in-class application of advanced modeling techniques to CMC data, spanning drug substance, drug product , and delivery device development. As ... of kinetic modeling, Bayesian methods, and predictive analytics to support product and process characterization, stability modeling, and specification setting. +… more