This position is part of the Manufacturing Science and Technology (MS&T) team responsible for ensuring the robust technology transfer and technical support of our mRNA platform at our Contract Manufacturing Organization (CMO) sites. The individual will work closely with CMOs to ensure that all aspects of technology transfer and technical support are successfully executed. The individual also must establish strong relationships with internal teams: Manufacturing, Supply Chain, Regulatory, and Quality Teams. The individual will provide engineering support for cGMP manufacturing operations at our CMO sites.
location: NORWOOD, Massachusetts
job type: Permanent
salary: $80,000 - 90,000 per year
work hours: 8am to 4pm
responsibilities: Here's What You'll Do:
Here's What You'll Bring to the Table:
- Support technology transfer activities for clinical products into CMOs.
- Provide technical support of cGMP manufacturing at CMOs including authoring of technology transfer documents, supporting change controls, closing manufacturing investigations, and helping validation actives.
- 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 process and 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.
- 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 one or more of the following bioprocessing unit operations: enzymatic reaction, chromatography, tangential flow filtration, buffer formulation, drug product formulation, and aseptic filling.
- Preferred: Prior experience providing technical support in a cGMP manufacturing environment.
- Preferred: Experience in biologics process development or cGMP manufacturing of biologic products.
- Preferred: Knowledge of single use bioprocessing technologies.
- Preferred: Knowledge of data management tools and statistical analysis.
- Preferred: Knowledge of cGMP equipment commissioning and validation.
- Experience level: Entry Level
- Minimum 3 years of experience
- Education: Bachelors (required)
- Process Improvement
- Biomedical (3 years of experience is required)
- Pharmaceutical Manufacturing (2 years of experience is required)
- Process Development (1 year of experience is required)
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.