Quality Senior Analyst I, Quality Control Chemistry - Woburn, MA Woburn, MA

Job Title: Senior Analyst I, Quality Control Chemistry

Location: Woburn, MA

Contract: 9 months

Position Summary

• Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. Senior Analyst, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed.
• This position will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to perform routine QC testing of in-process, DS, DP, and raw material samples. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs).

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.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $48.66 – $50.34 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.

We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.