Process Engineer III, Manufacturing Sciences & Technology
Genezen•Lexington, MA
•$105,000 - $130,000•Onsite
About The Position
The MSAT group plays a critical role in successful manufacturing of clinical and commercial products. The person in this role assists in the transfer of technologies, process validation and cGMP manufacturing of products. This individual will contribute as a core member of various cross-functional teams, and interacts extensively with other departments within Genezen, including Process Development, Manufacturing, Engineering, Quality, and Regulatory Affair etc..
Requirements
- BS/MS or degree in Engineering or other related scientific discipline preferred
- 3-6 (BS) or 1-4 (MS) years of relevant experience in gene therapy or other biotechnology industry
- Strong communication skills at individual, team, and organizational levels; fluent in English, written and verbal
- Experience in process development/analytical development/MSAT or GMP pharmaceutical manufacturing preferable in the area of viral vaccines or gene therapy
- Experience with technology transfer and GMP manufacturing technical support is preferred
- Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems
- Strong communication skills, including writing and oral presentations
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
- Ability to work in a fast paced environment with demonstrated capacity to juggle multiple tasks and demands
- Pro-active attitude, flexible, professional, independent and a team player
- Experienced project management skills
- Criminal background check required
Nice To Haves
- Ability to generate, manage, evaluate, and maintain critical data in a highly organized manner
- Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)
Responsibilities
- Supports downstream processing unit operations for process implementation, data collection, data analysis, and real time troubleshooting (i.e. chromatography, filtration, TFF, buffer generation, drug product filling)
- Assist technology transfer to GMP manufacturing by reviewing process description documents, technology transfer reports, reviewing master batch records, and providing on-floor support for transfer operations
- Assist manufacturing technical support, including process trouble-shooting, root cause analysis and investigation on process and/or quality discrepancies and deviations during GMP productions, change controls and CAPAs
- Support plan and execution of process/product life cycle management, including continuous process improvement to improve robustness/capacity/productivity, and to increase level of safety and/or compliance
- Experience with statistical analysis of process data (generation and trending control charts, linear regression and multivariate analysis)
Benefits
- Paid vacation days, amount based on tenure
- Paid sick time
- 10 observed holidays + 2 floating holiday + 1 volunteer day
- 401(k) plan with company match up to 6% of salary, vested immediately
- Share Appreciation Rights
- Choice of several healthcare plans
- FSA and HSA programs
- Dental & vision care
- Employer-paid basic term life/personal accident insurance
- Voluntary disability, universal life/personal accident insurance
- Accidental Death & Dismemberment (AD&D) Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
