Are you looking for a company driven by innovation and passion for saving lives that will inspire you and empower you to challenge yourself every day?
At The Discovery Labs Center for Breakthrough Medicines, we are building an unprecedented enterprise that brings together the necessary capabilities, infrastructure, and world-class leaders to facilitate the development and manufacturing of cell and gene therapies from bench to bedside.
The Discovery Labs Center for Breakthrough Medicines aims to be the leading global provider of world-class cGMP manufacturing, turnkey laboratory solutions, critical materials, and office space that support therapeutic products and services to the biotechnology and pharmaceutical industry. Our mission is to help accelerate the delivery and affordability of life-changing therapies to those who so desperately need them. Through seamless access to the development and manufacturing capabilities required to launch innovative cell and gene therapies, The Discovery Labs Center for Breakthrough Medicines can deliver the therapies needed to save countless lives. Our gene therapy resources and manufacturing technologies address the full spectrum of service needs from early-stage innovation through commercial launch.
The Discovery Labs Center for Breakthrough Medicines is looking for a Process Development Scientist to join our highly innovative team and add significant value to the organization.
The Difference-Making Role: Process Development Scientist
Job Summary: The PD Scientist is responsible for developing robust and scalable downstream manufacturing process to support early and late phase gene therapy products in the Center for Breakthrough Medicine pipeline. The PD Scientist will also be responsible for providing technical support to technology transfer, scale up, and internal/external manufacturing, as well as regulatory filings as needed.
devise new processes, or refine existing ones, to optimize the manufacturing process
plan, carry out and supervise process trials in laboratories, pilot plants or factories
scale up the production process via plant trials, making changes to raw materials or components, and process parameters to ensure quality is maintained during large-scale production
improve yields by reducing costs, e.g. investigating alternative materials or new machinery to improve efficiency and quality in bottleneck areas
devise test methods to assess the production process
validate new processes and show that they're an improvement
work with product pipelines at various stages of development
develop formulae, specifications and label declarations, and ensure compliance with the finished product specifications
advise on equipment modification to enable process changes for new product development
read and write technical reports and specifications, maintaining appropriate records
initiate and generate ideas based on reading and research.
Education and Experience:
Ph.D. in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline, or MS with 3+ years of relevant industry experience.
In depth understanding and hand on experience in one or more of the following area is required: preparative chromatography, membrane filtration (NFF, TFF, viral filtration), membrane chromatography, continuous processing, process modeling.
Experience with high throughput liquid handling and robotics as applied to downstream process development is preferred.
Knowledge of analytical methods to support product and process characterization is preferred.
Knowledge of statistical methods for DOE design and data analysis (i.e. JMP) is highly desirable.
Experience with downstream process development of biological products, such as viral vectors, vaccine, recombinant proteins is preferred.