The Andover Site Technical Services Group (ASTS) is seeking a highly motivated individual for a Process Scientist/Engineer.
The ideal candidate will have hands on experience with large scale biopharmaceutical processes/equipment principles and practices.
Regulatory compliance and Good Manufacturing Practice mindset/experience is desirable.
The role encompasses the ongoing lifecycle process/product management of commercial and near-commercial biopharmaceuticals drug substances.
The individual will be expected to provide detailed technical process understanding and expertise in support of processes within all manufacturing suites at the Andover, MA manufacturing site including both mammalian and bacterial processes.
A track record of solving technical, regulatory, compliance and operational issues through collaboration with stakeholders and other scientists, engineers, operations, and quality control/quality assurance groups.
Familiarity with Lean/Six-Sigma methodologies is desirable.
Provide technical process support in determination of root cause of process excursions and support/lead implementation of corrective actions.
Provide technical process data gathering/summarizing in order to support evaluation of process and regulatory trends/requirements and subsequent implementation of associated changes.
Supporting senior process engineers for the lifecycle management of one or more biopharmaceutical products
Collation and communication of process performance for the purpose of developing projects for process improvement/robustness.
Be an active participant in cross functional teams in the evaluation and implementation of process improvements, process changes and new manufacturing technologies.
Take on assignments to support evaluation and implementation projects
Assist in planning for and monitoring of production campaigns
Assess changes to equipment, and processing and their impact on the process performance(s).
Take on projects in support of operational/process robustness across multiple products and manufacturing suites
Be responsible for or assist with regulatory filings and regulatory query responses under critical timelinesRole Success Factors
Ability to work and collaborate on multi-functional teams
Ability to interpret and communicate technical and process information/issues concisely to facilitate decision making
Project management capabilitySelf-motivated and able to drive multiple assignments simultaneously
Able to adapt to changing priorities as business needs demand
Minimum BS or MS
+ 4 years experience in science or engineering working in a Pharmaceutical or Biopharmaceutical environment.
+6 years experience in science or engineering working in Pharmaceutical or Biopharmaceutical environment