Position Overview:

The Quality control Analyst will support critical analytical method implementation workstreams in support of GMP testing laboratory start-up plan. These workstreams include analytical instrument qualification, critical reagent management, execution of technical protocols, and supporting the implementation of programs and procedures in a new Quality Control laboratory located in Cambridge, Massachusetts.

Primary Responsibilities:

• Maintain QC laboratory including instrument calibration, PMs, and operational SOPs.
• Perform Release Testing, Qualification, Validation and Method Transfer for various cell therapy methods.
• Perform stability testing, assist, keep records of stability sample pulls, and write/revise stability protocols.
• Support the implementation and execution of training programs within CoE.
• Work independently and assist Sr. Analysts for sample and stability analyses.
• Responsible for daily and weekly lab chores.
• Collaborate with multiple departments for on-time completion of variety of analyses.
• Participate in process improvement for a faster turnaround time, OTIF (on-time in full) completion of projects.
• Prepare the data packet for review and peer-review the data.
• Maintain stability sample inventory and perform stability sample shipments to external contract laboratories and/or sample storage vendors.
• Support stability data analysis along with stability document reviews.
• Tracking and ordering of laboratory reagents and materials.
• Sample receiving per the BEAM-SOP guideline.
• General cleaning and upkeep of the laboratory and equipment.
• Escalate complex issues to QC Manager and SMEs in the lab.

Technical Skills:

• Prior lab-experience is needed.
• GMP experience as a QC personnel is desired.
• Technical least one of the following analyses: mRNA, LNP, CFU, Potency assay, gRNA, NGS assay, Flow Cytometry, PCR, ELISA, and/or Multiplex.
• Hands-on experience is preferred (but not mandatory) with HPLC (DAD-CAD, UV-ViS), UHPLC, and/or Mass-Specs.
• Analyze data; interpretation of data within given parameters.
• Prior knowledge of LIMS, VEEVA, and/or KNEAT preferred.

Qualifications:

• Bachelor’s degree required, preferably in a chemistry, life science, or related discipline.
• 0-3 years relevant experience.
• Prior GMP experience is desired.
• Scientific knowledge and direct experience with analytical method transfer processes.
• Advanced technical writing skills.
• Advanced problem-solving ability.
• Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
• Collaborative with “Team First” mentality.
• Communicate effectively with peers, and demonstrate collaboration across different functional groups.