Scientist Formulation & Dowstream process xNA – Exothera

The formulation and DSP (downstream process) Scientist is responsible for the process adaptation and project execution in the scope of his/her activity. 

He/she acts as an expert in the formulation development of nucleic acid (LNP) including DSP technology (such as UF, Chromatography, and filtration).

He/she is responsible for the process transfer and execution supervision from non-GMP to GMP environment.

He/she works in close collaboration with the Technical Lead, the head of development and production, the analytical science/ QC team, the project leaders, and QA.

Accountability:

  • Design and execute innovative formulation and downstream process development for xNA vaccine, gene therapy, and biosimilar applications. 
  • Deliver technical expertise on one typical DSP unit operation. (such as TFF, depth filtration, chromatography) and formulation of LNP.
  • Develop detailed experimentation protocols and execute the planning/organization of the experiments in his/her scope of activities
  • Propose creative technical solutions to meet the project’s goals 
  • Review run forms and raw data.
  • Perform preliminary analysis and interpretation of functional data.
  • Report and present results in front of internal stakeholders and external clients.
  • Follow-up on deadlines and project objectives within his/her own scope.
  • Implement and maintain best practices for formulation and DSP operations

RESPONSIBILITIES

  • Lead the team for developing formulation and DSP activities for Nucleic Acid applications.
  • Act as an expert on typical formulation and DSP activities, such as Chromatography, tangential filtration (TFF), filtration, LNP
  • Determine CQAs and CPPs for each product in collaboration with the stakeholders
  • Support interactions with external Clients as required. Actively engage with internal clients & support units across various teams. 
  • Attend meetings to support results presentation, provide technical feedback and insights, and assist in troubleshooting and operational efficiency. His/ her role is crucial in ensuring effective communication and coordination between all involved teams.
  • Champion the principles of customer-centricity throughout all interactions and operations, ensuring these values are in all processes
  • In development activities, write an experimental protocol, study plan, and work-unit plans.
  • Review run forms and raw data.
  • Ensure the experiment’s data is captured in a format that allows appropriate reports.
  • For GMP activities, ensure that all data and results are properly recorded in specified forms (paper and electronic) according to EHS & GMP rules, SOPs, Working Instructions, and Good Documentation Practices. 
  • Write, update, and review WI’s, SOP’s, BR’s, BOM’s. and be the SME during audits
  • Troubleshoot and investigate deviations and unexpected events, and support CAPA plans.
  • Execute initial and routine qualification & validation related to manufacturing operations

QUALIFICATIONS AND SKILLS

  • Master’s or Bachelor’s degree (or equivalent) in life sciences, chemistry or biology field
  • Minimum of 5 years experience in process development and/or GMP clinical/manufacturing activities. First experience in formulation and DSP are required.
  • xNA experience is a must.
  • Solid understanding of compliance and cGxP considerations.
  • Experience working in a matrix organization. 
  • Demonstrated focus on continuous improvement and maintaining high-quality standards
  • Subject Matter Expert (SME) in their area of focus (DSP and formulation).
  • Excellent communication skills, with the ability to impart knowledge and inspire confidence among colleagues.
  • Inherent curiosity, with a commitment to continuous learning.
  • Self-motivated, with a keen interest in contributing to a fast-growing company.
  • A mindset focused on quality (GMP).
  • Enthusiastic and agile to work on a variety of projects in a multi-tasking environment.
  • Right First Time & Customer-oriented.
  • Fluency in English and French, both written and spoken, is essential