Senior Analyst I, Quality Control Chemistry

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Tandym Tech
Woburn, MA, United States
  • Environmental
  • FlexTime
  • Applications have closed

A top client is hiring a Senior Analyst I, QC Chemistry on a long-term contract basis. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs).

This role is 100% onsite in Woburn, MA.

Responsibilities

  • Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)

  • Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods

  • Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).

  • Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.

  • Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods.

  • Method Transfer / Validation of QC chemistry methods at internal and external laboratory.

  • Model leadership behaviors and mentor/train junior staff

  • The job responsibilities may change as needed to support activities relevant to the clinical phase.

Qualifications:

  • Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.

  • BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.

  • Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred.

  • Experience working with external contract labs (CMOs, CROs) is a plus.

  • 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 good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.

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