Sr. Scientist, Product Complaints, Manufacturing Science and Technology
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location: Norwood, Massachusetts
job type: Permanent
salary: $115,000 - 195,000 per year
work hours: 9 to 5
This is a newly created role in the Manufacturing Science and Technology (MST) department to support the company's Drug Product (DP) MST activities. This role will provide direct support for investigating deviations and product complaints related to drug product packaging and drug product manufacturing.
Reporting to the Director DP MST, the incumbent will be responsible for technical support of technical product complaints and for investigations related to drug product manufacturing / primary and secondary packaging. The role requires expertise in analytical methods related to product quality attributes, analytical methods for glass analyses, and analytical methods for identification of extrinsic unknown substances.
- Lead cross functional investigations into drug product technical product complaints and manufacturing deviations.
- Manage investigational testing at contract laboratories to assist in investigations.
- Author testing protocols and investigation reports.
- Represent MST on the company product complaints team (QA, Supply Chain, Regulatory).
- Support generation and analyses of drug product technical complaint metrics. Regularly review and assess manufacturing metrics and product complaint trends.
- BS, M.S. or Ph.D. in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.)
- A minimum of 5 years related work experience (8 yrs with a BS)
- Prior experience in an analytical testing function (analytical development, QC)
- Prior experience in sterile manufacturing of biologics.
- Experience in root cause analysis, training in Six Sigma, Kepner-Tregoe or other root cause analysis tool preferred
- A highly collaborative team player capable of data driven solutions.
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.