Proclinical is recruiting for a Scientist for a pharmaceutical company located in Cambridge, MA. Successful candidate will be empowered to assist in the development of cellular therapy products and work on cross-functional teams.
This Contractor Scientist position will play an important role in developing the clinical manufacturing processes and/or methods for developing cellular therapy products. Independently, or with minimal supervision, plans and executes process, characterization and qualification studies. Prepares study protocols, reports, technology transfer documentation, and regulatory documents for clinical trials. Presents study results at team or department meetings, to external partners or at conferences.
Job Responsibilities:
- Work with departmental and/or cross functional peers to execute on assignments, under limited supervision.
- Own responsibility for technical aspects of a project.
- Prepares complex experimental protocols.
- Contribute significantly to project work which may include multiple projects within functional area.
- Review, interpret and communicate data internally and prepares technical reports.
- Propose and implement resolutions to technical problems/issues.
- May participate actively on GCT project teams by communicating activities from designated functional area to project team.
- Design experiments/unit operations independently including follow up experiments as necessary.
- Assist with the development of project strategy and communicate complex data/decisions within department and cross functionally as necessary.
- Support local initiatives as directed by supervisor and participates in global CMC or functional initiatives as appropriate.
- Serve as a technical resource for junior staff and leverages expertise in laboratory technology as a functional resource/trainer.
- Coordinate within departmental as well as cross functionally with peers on project work.
Skills and Requirements:
- BS in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience.
- MS in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience.
- PhD in chemistry, biology, pharmacy, chemical or biomedical engineering or related pharmaceutical science; 0+ years relevant industry experience.
- Previous experience working in lab setting.
- Analytical and Problem-Solving Skills - able to troubleshoot critical issues or problems and determine causes and possible solutions using appropriate information.
- Ability to work well in a highly cross-functional team environment.
- Able to expresses one's self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; timely and effectively communicates issues to supervisor; technical writing skills to support contributing to internal technical documents.
- Experience in developing cell therapy or biological products, scale-up manufacturing processes.
- Understanding and experience of using the tools of Design of Experiment (DOE) and Quality by Design (QBD) in process & assay design, development, qualification and validation is a plus.
- Beneficial to have 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.
To Apply:
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 call Nikki Ranieri at (+1) 215-531-5288 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.
#LI-NR1
#Scientific
