Job Description
Job Summary:
- The drug product development team within the process and technology development organization at Client is seeking a highly motivated Lab Associate.
- Client has paved the way for gene therapies and is a recognized leader in the transformational field.
Duties and Responsibilities:
- As a member of our dedicated process development function, the scientist will play a key role in supporting early and late-stage drug product development activities.
- Support formulation and fill/finish process development (including in-use and administration, container closures and device and raw material aspects) of early and late stage gene therapy projects.
- The associate will also support commercial projects and/or life cycle projects as needed.
- Execution of studies to support formulation, process development E&Ls and compatibility and in use and administration studies.
- Lead identification, designing and execution of administration device (large molecule parenteral devices) studies.
- Execution of analytical biophysical characterization and high throughput formulation development and screening.
- Collaborate and work with cross functional teams (e.g. with analytical development, drug substance, CMC, clinical etc.)
- Prepare and present (e.g. data) as needed.
- Support downstream process development (including for successful DP process and formulation development).
- Support external/ internal manufacturing process and participate troubleshooting and investigations.
- Ensure compliance with client procedures and good practices (e.g. documentation).
Requirements:
- B.S in biochemistry, pharmaceutics, chemical engineering, material sciences, mechanical engineering or related discipline with 0–2 years of industry experience .
- Experience/background in large molecule drug product development (formulation and/or process), material sciences, and/or container closures and devices (parenteral administration) development is preferred but not required.