As a Senior Supply Planner, you will be responsible for leading and owning the Sales and Operations Planning (S&OP) process, proposing supply scenarios, running supply planning software, monitoring inventory, acting as a subject matter expert (SME) at CMO Site Supply meetings, managing the Master Production Schedule (MPS), and taking ownership of inventory levels at our third- party logistics (3PL) partner.

Work closely with representatives from Research and Development, Manufacturing, Quality Assurance, Regulatory Affairs, and other departments to ensure seamless process integration and change management.

Work in close cooperation with CMC and Quality Assurance to ensure timely manufacturing, packaging, labeling, and shipping of supplies for the clinical trials. Knowledge of the drug development process, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Perform pilot scale downstream purification process and manufacturing (post cell lysate to final formulation) by utilizing column chromatography, CsCl, UFDF, and various filtration steps.

Perform various manufacturing tasks such as operating, troubleshooting, sterilizing, maintaining, preparing, and cleaning of various process equipment such as stirred-tank bioreactors, media/buffer solutions, disc stack centrifuges, homogenizer, dryer, TFF skid, chromatography systems, parts washers, and CIP systems, under the guidelines of established SOPs and cGMP regulations.

Reporting to the Associate Director, Process Development, the Associate Scientist will contribute to and support late-stage development of GMP-compatible manufacturing processes for production of CARGO’s cell therapy products.

Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

You will collaborate closely with multiple teams across Process Development, Analytical Development, Regulatory Affairs, Quality and Manufacturing. The Bioprocess Development Associate will develop and optimize protein and protein-conjugate manufacturing processes.

We are seeking a highly motivated Manufacturing Associate to support our new Viral Vector Biotechnology facility. As part of a team, process mammalian cell culture in flasks, CellSTACK chambers and single use bioreactor systems, as well as assist with transfection of cells and harvest of viral vectors.

This highly visible role will report to the Associate Director, FP&A and partner closely with R&D business partners including CMC and Manufacturing & Supply Chain. Support the budgeting and forecasting, financial planning & analysis, and resource management process for R&D.

Proven small molecule process development expertise with experience in clinical manufacturing, scale-up and technology transfer. Further, you will oversee drug substance clinical manufacturing, scale-up, registration batches, process validation, and commercial manufacturing preparedness.

Collaborate and work closely with Quality Control, Analytical Development, External Manufacturing, other Process Development teams, Technology Transfer, Regulatory and Program Management to understand customer requirements (both internal and external), develop strategic support plans and execute upon them.

Our iron-rich cathodes are industry proven drivers of EV, ESS, and consumer electronics applications, and our team of industry leaders is developing a robust supply chain and manufacturing pipeline to deliver Inflation Reduction Act (IRA) qualified cathodes to our customers.

Partner closely with the CMC, Regulatory, and Quality teams to ensure smooth transition from process validation to routine commercial manufacturing. Manage the Global Supply Review (GSR) process specifically ensuring no impact to global supply, closely managing routine manufacturing for API & Drug Product & Packaging.

The candidate should have an associate degree or bachelor’s degree in Materials Science, Chemical Engineering, or equivalent and relevant industrial experience. OneD is looking for the battery process technician to support the material evaluation at electrode and cell level.