ProClinical is partnering with a leading global pharmaceutical company to advertise a vacancy for a Scientist I position. This organization boasts a superb pipeline of products that include treatments for diabetes, cancer, and asthma. Based in Massachusetts, this is an exciting opportunity to work with a worldwide research-based company and assist in the development of cellular therapy products.
The Scientist role will play an important role in developing the clinical manufacturing processes and/or methods for developing cellular therapy products. They will plan and execute process, characterization, and qualification studies, whilst preparing study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. Finally, they will present study results a team or departmental meetings, to external partners, or at conferences.
- Working with departmental and/or cross functional peers to execute on assignments, under limited supervision.
- Owning responsibility for technical aspects of a project.
- Preparing complex experimental protocols.
- Contributing significantly to project work, which may include multiple projects within functional area.
- Reviewing, interpreting, and communicating data internally, (e.g., to supervisor, project teams) and preparing technical reports.
- Proposing and implementing resolutions to technical problems/issues,
- Participating in GCT project teams by communicating activities from designated functional area to project team.
- Designing experiments/unit operations independently, including follow up experiments as necessary.
- Assisting with the development of project strategy and communicating complex data/decisions within department and cross functionally as necessary.
- Supporting local initiatives as directed by supervisor and participating in global CMC or functional initiatives as appropriate.
- Serving as a technical resource for junior staff and leveraging expertise in laboratory technology as a functional resource/trainer.
- Coordinating within departmental as well as cross functionally with peers on project work.
- At least a Bachelor's degree in chemistry, biology, pharmacy, engineering, or a related pharmaceutical science, though an advanced degree such as a Master's or Ph.D. is preferred.
- Relevant industry experience based on the level of education - at least 8 years for a Bachelor's degree graduate, at least 6 years for a Master's degree graduate, and any number of years for a Ph.D. graduate.
- Previous experience working in lab setting.
- Experience in developing cell therapy or biological products and scale-up manufacturing processes.
- A thorough understanding of using the tools of Design of Experiment (DOE) and Quality by Design (QBD) in process and assay design, development, qualification, and validation.
- Experience in principles and practices of cellular immunology and/or stem cell biology, including cell culture, cell transfection and transduction, development and execution of functional in-vitro methods relevant for various types of immune cells and/or stem cells.
- Advanced proficiency in the use of applicable lab equipment and operations.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office, Concur, and Visio.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kevin Cassini at +1 215 531 5288 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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