Senior Scientific Associate
50 Northern Ave, Boston, MA 02210 Boston, MA 02210 US
Pay Rate Range: $37-$45
The Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA) will have the primary responsibility is to support deviations, CAPAs, executed batch records and to provide continuous manufacturing PAT support at the Vertex Manufacturing Center (VMC). The Senior Scientific Associate, MTIA reports directly to the Sr. Manager, MTIA.
The responsibilities of this position may include, but are not limited to, the following:
· Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture.
· Lead, write and review deviations and investigations for the VMC, including the Drug Product Facility, Facilities, Materials Management and the Kilo Lab.
· Develop corrective/preventative action plans (CAPAs) through root cause analysis of deviations.
· Author and submit revisions to controlled documents in support of GMP Operations, including Standard Operating Procedures, Work Instructions and Master Batch Records.
· Review executed batch records to ensure compliance with GDP/GMP requirements.
· Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.
· Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes
· BS/MS in chemical, mechanical, or material science engineering or comparable degree.
· Two or more years experience working in a GMP manufacturing environment in the pharmaceuticals, biotechnology or medical device industries.
· Understanding of cGMP concepts and general practices.
· Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
· Experience working in Quality Management System for regulated documents (e.g., Veeva or Trackwise) is a plus.
· Formal training in root cause investigations and technical writing a plus
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