Open job position:
Title: Research Scientists
Job type: Full timeJob Summary
Cellmig Biolab's world-class research and development team is turning pioneering discoveries into translational medicines for the diagnosis and pharma-therapy of cancer metastasis. We have successfully identified a novel organelle termed cytocapsulae, which allow for a new mechanism of cancer cell migration. Our goal is to use this finding to create breakthrough biomolecules and diagnostic devices to target tumor metastasis. We are working in advancing our products in clinical validation programs and applications.
The Core Research Center at Cellmig Biolabs Inc. is searching for 5 Research Scientists
to join our Antibody Development team. We are seeking highly motivated and independent individuals with a background in Biochemistry, Protein chemistry and/or Antibody development work. A strong candidate will play a critical role in the validation of our first antibody product for FDA approval, performing cutting edge cancer biology research. Cellmig offers growth potential and a stimulating environment with a culture of excellence in science and product development. The candidate will be part of an integrated, interdisciplinary team developing powerful new diagnostic products for cancer metastasis.Duties and Responsibilities
The core responsibility of this position is to build and maintain Cellmig's research and validation needs for the company's clinical diagnostic In Vitro Diagnostic (IVD) immunohistochemistry (IHC) antibodies, in addition to the development of future diagnostic devices. This role will work directly with the Research Team or Validation team to establish and drive the validation and verification needs for FDA approval, as per the Quality Systems Management requirements and regulations found in ISO 13485: 2016, FDA QSRs, and other applicable standards for IHC Assays.
This individuals will work with the antibody development team to assist and guide on planned researches and assays. Such activities include, but not limited to:
- Design, develop, validate, and maintain Cellmig's protein assays/methods and procedures for Cellmig antibody product(s) for clinical diagnosis.
- Perform, troubleshoot and/or optimize established procedures and protocols, including immunohistochemistry staining, SDS-Page, Western blot, mammalian cell culture, fluorescent microscopy and other related cell and molecular biology assays.
- Play a crucial role during the Design and Development phases of the antibody products and clinical diagnostic products.
- Contribute to tasks for product Verification and Validation activities of new product developments and next generation devices.
- Provide support and training on systems, policies, and procedures related to validation, document control, and product development.
- Analyze and interpret data collected in experiments and studies.
- Take initiative to drive projects forward by suggesting experiments to test, researching new methods/cutting edge technology, and always learning new skills. Recommend and implement new tools to optimize processes, procedures, and test methods.
- Follow proper documentation control procedures. Maintain accurate laboratory records.
- Assist other team members and support expansion of the Antibody Development team.
- Present data and project status as weekly and/or bi-weekly team meetings.
- Work with and efficiently communicate with project manager, Validation team members, Quality Assurance and Quality Control regarding developments in the project tasks. Contribute to critical submission needs for the product(s).
- Proactively solve problems to drive project advancement.
This position will assist with developing, optimizing, and executing IHC assays for validation studies, such as precision, stability and reproducibility assays. Together with the validation team members, this position will perform analysis of these studies, along with complex reviews of the product(s) to determine that the product(s) perform as per the stated intended use.
YourMembership. Keywords: Staff Scientist, Location: Cambridge, MA - 02139