Research Associate, Process Development

Job Title: Research Associate, Process Development

Job Number: 34058

Location: Andover, MA

Job Description

Your duties will involve the production of DNA, mRNA, saRNA, and LNP (formulation), including the application of DSP (downstream process) technology like UF, Chromatography, and filtration. This responsibility falls under the guidance of a Scientist. Additionally, you will be tasked with close collaboration with the technical lead, the heads of development and production, analytical sciences, the technical team, and QA.

Responsibilities

• Plan and coordinate the steps of the production process and manage equipment, ensuring their proper assembly, preparation, and verification. Conduct xNA production in adherence to Environmental, Health, and Safety (EHS) standards, Standard Operating Procedures (SOPs), and Research and Development (R&D) documentation requirements.
• Undertake the production of DNA and mRNA/saRNA in Upstream Processing (USP) and Downstream Processing (DSP), utilizing a standardized and fully automated process. 
• Carry out the formulation process, encapsulating mRNA/saRNA in Lipid Nano Particles according to established standards. 
• Perform the filling of small batches of mRNA/saRNA as needed.
• Maintain a clean and safe work environment by following established cleaning and housekeeping routines. 
• Record all data and results in designated forms, both paper and electronic, in accordance with EHS and R&D regulations, SOPs, Working Instructions, and Good Documentation Practices.
• Troubleshoot and investigate deviations and unexpected events, actively contributing to Corrective and Preventive Action (CAPA) plans. 
• Write, update, and review Experimental Protocols (EP), Report Protocols (RP), and Bill of Materials (BOMs). 
• Conduct basic maintenance and calibration operations and propose and assist in the implementation of process improvements.
• Adhere to EHS rules and instructions, collaborating with the employer, EHS department, and hierarchical line in risk analysis, accident/incident investigations, and the proposal of preventive/corrective measures to mitigate risks. 
• Attend EHS training sessions and promptly identify and report risks and unsafe situations.

Required Skills

• Bachelor’s degree in Life Sciences or equivalent expertise gained through practical experience. 
• A track record of 5 years of successful and pertinent experience in Development activities. 
• A collaborative team player with strong interpersonal skills. 
• Motivated by curiosity, displaying a constant desire to learn and improve processes and practices.
• Demonstrates the ability to work independently and possesses "technical-manual intelligence" with a practical sense. 
• Enthusiastic and capable of managing various projects in a multitasking environment.