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Senior Analyst I, Raw Materials Quality Control

Cambridge, MA

Posted: 05/17/2022 Employment Type: Contract Job Category: Clinical: Quality Job Number: 3033

Job Description

This position reports to the Associate Director, Quality Control, and will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to support routine QC testing for Raw Materials for Gene   therapy products.

The Senior Analyst will specifically support the Raw material and gene therapy program pipeline (as needed) including but not limited to Project Management of the raw material program and development of testing strategies

Responsibilities include:
  • Assist in project management of raw material program implementation including tracking of key milestones and timelines
  • Assist in development of testing strategies for raw material including supporting bringing on contract testing lab
  • Documentation for raw material testing program including SOP generation, risk assessment documentation, specification development documentation
  • Assist in risk assessment exercise for raw material testing criteria 
  • Provide leadership and subject matter expertise for analytical method development, transfer and validation activities for raw materials / starting materials for gene therapy.
  • Significantly contribute to build the raw material program.
  • Work closely with key stake holders – manufacturing, QA, validation, MSAT, PD, Safety for moving the program forward.
  • Investigate and evaluate cutting edge raw material analytical instrumentation. On-board new instruments to the lab
  • Manage work assignments, analyze and interpret test results, and conduct necessary troubleshooting independently with minimal supervision of the manager
  • Work on laboratory investigation, change control, deviation and CAPA as appropriate for internal and external testing.
  • Write, prepare and present technical data, technical reports and standard operating procedures (SOPs) for internal use and transfer to external sites
Requirements/Qualifications:
  • We are looking for a motivated and detail-oriented individual with excellent problem-solving abilities for interrogating complex molecular entities.
  • Able to work independently with minimum supervision
  • BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years
  • Knowledge and hands-on experience with Raw Material analytical techniques-FTIR, UV-Vis, Osmolality, pH, NIR, Raman, Potentiometric titration is strongly preferable
  • Knowledge of USP, Ph, Eur and JP is strongly preferable
  • Knowledge with QC raw material sampling is a plus
  • Experience with statistical analysis software (SoftMax, JMP) preferred.
  • Experience working with external contract labs (CMOs, CROs) is preferred.
  • Ability and desire to work in a fast-paced, start-up environment.
  • Strong collaboration and team-working skills.
  • Strong communication, interpersonal and organizational skills.
  • Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
  • Should be highly motivated, demonstrate strong technical leadership skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
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