Senior Analyst I, Quality Control Chemistry

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.