Sr. Scientist / Sr. Engineer Manufacturing Science and Technology
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location: Norwood, Massachusetts
job type: Permanent
salary: $140,000 - 155,000 per year
work hours: 8 to 4
This is a newly created role in the Manufacturing Science and Technology (MST) department to support our Drug Product Contract Manufacturing Organization (CMO) activities in the USA. Based in Norwood, MA, this role will provide direct support for DP fill and finish technology transfer, process start up, and commercial cGMP manufacturing at USA CMOs.
Reporting to the Associate Director CMO MST, the incumbent will be responsible for technology transfer, process validation, person in plant CMO support, and project leadership for cross functional, cross site technical issues. The Sr. Scientist / Sr. Engineer will work alongside our CMO operations and QA to ensure robust, compliant cGMP manufacturing performance at drug product CMOs.
- Be the subject matter expert (SME) for drug product fill/finish (aseptic manufacturing) processes at the company's CMOs.
- Working with a our Drug Product team (Operations, QA, Supply Chain), be the point of contact for technical issues that occur at CMOs.
- Lead cross functional technical teams transferring processes, validating processes, evaluating start up performance, conducting deviation investigations to determine root cause, and managing change.
- Maintain manufacturing performance metrics. Regularly review and assess manufacturing performance.
qualifications: Here's What You'll Bring to the Table:
- 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)
- Expert in cGMP aseptic fill finish operations including prior experience validating aseptic manufacturing processes.
- Prior experience with cGMP stability studies and the use of product stability data to evaluate risk to drug product during manufacturing.
- A highly collaborative team player capable of data driven solutions.
skills: Biology, Chemistry, 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.