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location: Norwood, Massachusetts
job type: Permanent
salary: $109,000 - 129,000 per year
work hours: 8 to 4
This position supports cGMP Manufacturing activities at the Norwood site. Reporting to the Associate Director, MST, the Sr. Engineer / Sr. Scientist will be responsible for managing technology transfer and be the MST lead for sustaining cGMP manufacturing operations, for plasmid production at Norwood. This includes both small scale plasmid production for the Personalized Cancer Vaccine as well as large scale plasmid production. Here's What You'll Do:
- Lead cross functional Technology Transfer teams for plasmid projects. Track and coordinate project milestones to enable cGMP compliant implementation.
- Work with Manufacturing, Facilities, Digital, and Quality to implement additional production trains in both small scale and large-scale plasmid production.
- Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities.
- Be the subject matter expert for plasmid processes at both small and large scale. This includes supporting equipment commissioning/validation, process transfer, MES implementation, troubleshooting, and leading technical investigations.
- Author process descriptions, technology transfer documents, deviation/investigation reports, technical reports, and manage technical CAPA/change controls.
- Establish and maintain process performance trending / metrics using digital information and statistical analysis tools.
- 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
qualifications: Here's What You'll Bring to the Table:
- Biochemical engineer, Chemical engineer, Microbiology, or Biochemistry background. Ph.D. with 2-5+ years experience or MS with 8+ years experience or BS with 10+ years of experience in a pharmaceutical or biotechnology company.
- Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
- Demonstrated expertise bioprocessing including fermentation and purification of protein and/or nucleic acids. Expertise in at least one of the following areas: chromatography, membrane separations, fermentation, enzymatic reactions, and formulation.
- Technical agility. The capability to manage diverse technical areas.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Preferred: Expertise in molecular biology
- Preferred: Experience in biologics process development and scale up / scale down.
- Preferred: Experience with single use bioprocessing technologies.
- Preferred: Proven track record leading and managing cross functional teams.
- Preferred: Knowledge of digital cGMP tools. For example: SAP, OSI PI(), MES (eBR), Unicorn, eQMS
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.