Molecular Assay Scientist

Employer
Synectics Inc
Location
Cambridge, Massachusetts
Salary
Commensurate
Posted
Jan 15, 2025
Closes
Feb 07, 2025
Ref
2881097751
Role Type
Scientist
Career Level
Experienced Career
Education
Bachelor
Work Mode
Onsite
Contract Type
Full Time
Organization Type
Commercial / Industry
Description :
  • Will work with a talented and experienced team in our Technical Research and Development organization at Cambridge, Massachusetts.
  • Will be an important point of contact for the coordination and execution of molecular, potency and characterization assays, qualification studies, and method transfer activities within area of expertise.
  • Will interface regularly and build relationships with other functions such as Process Development, Quality Control and Manufacturing Sciences & Technology to collaboratively drive projects to meet the established timelines while maintaining the highest quality and data integrity standards.
  • Will uphold company Values & Beliefs and Code of Ethics to successfully support our bold mission of delivering effective CAR-T cell products for patients in need.
  • Perform analytical testing including flow cytometry, cell count, cell viability, qPCR/dPCR, potency, etc. following appropriate SOPs and procedures.
  • Review and approve data by other team members.
  • Record and maintain meticulous records in electronic laboratory notebook in compliance with Quality standards
  • Identifies opportunities for method improvement
  • Execute qualification/optimization of analytical methods
  • Drive project timelines and deliverables while meeting internal quality and data integrity requirements
  • Communicate effectively and present complex data within the department and cross-functionally
  • Author and review method related technical documents to ensure completeness, accuracy, consistency and clarity
  • Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency
  • Serves as a technical associate expert to support analytical testing and implementation of novel analytical methodologies for our CAR-T cell therapy products.

Requirements :
  • BA/BS or MS in biology, chemistry, biochemistry, microbiology or other related science + 1 year of prior experience in industry or academia.
  • Understanding of the basic scientific principles underpinning the analytical methods such as flow cytometry, PCR, ELISA, cell-based assays
  • Expertise with aseptic technique and mammalian cell culture, Human T-cell culture experience a plus
  • Ability to communicate clearly with internal or cross-functional teams
  • Detail-oriented with expertise in problem solving & demonstrated ability to work in a team environment
  • Established ability to work in a regulated environment
  • Good presentation skills and scientific/technical writing skills
  • Experience writing laboratory SOPs and technical instructions is preferred
  • 0-4 years of experience in pharmaceutical, biologics industry
  • Understanding of the concepts of cGxP.
  • Strong written and verbal communication skills are essential