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location: Norwood, Massachusetts
job type: Permanent
salary: $70,000 - 110,000 per year
work hours: 9 to 5
This position is part of the company's Manufacturing Science and Technology (MST) team responsible for ensuring the robust technology transfer and technical support of our large-scale mRNA and lipid nanoparticle platform and buffer manufacturing in cGMP Manufacturing. The individual will work closely within MST, and with Process Development, Manufacturing, Regulatory, and Quality, to ensure all aspects of technology transfer and technical support are successfully executed. The individual will provide engineering support for process equipment used at the company's cGMP manufacturing operations.
- Support technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance.
- Provide technical support of cGMP manufacturing including authoring of technology transfer documents, change control, and manufacturing investigations. Collaborate with process development on studies to determine root cause for deviations.
- Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories.
- Lead cross functional troubleshooting and operational improvements for manufacturing equipment.
- Assist in design and engineering of disposable systems used in bioprocessing including aseptic bioprocessing bags and tubing manifolds. Review design and engineering drawings. Execute studies to demonstrate equipment fit and process performance.
- Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing.
- MS&T will be providing weekend coverage for Manufacturing and as part of the team you will need to be flexible to work a weekend day on a rotational basis.
- Biochemical engineer, Chemical engineer, or Biochemistry background. BS with 2 to 5 years of experience or MS with 0 to 2 years experience in a pharmaceutical or biotechnology company.
- Process development or operational experience in multiple bioprocessing unit operations which may include: fermentation, enzymatic reaction, chromatography, tangential flow filtration and buffer formulation.
- Prior experience providing technical support in a cGMP manufacturing environment.
- Experience in biologics process development or cGMP manufacturing of biologic products.
- Knowledge of single use bioprocessing technologies.
- Knowledge of data management tools and statistical analysis.
- Knowledge of cGMP equipment commissioning and validation.
- Excellent judgment and ability to communicate manufacturing issues in a scientifically sound and understandable way.
- Outstanding communication skills (verbal and written).
- Ability to manage projects in a fast-paced environment.
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
skills: Chromatography, 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.