Job Title: Sr. Scientist/Scientist Process Development
Job Number: 34057
Location: Andover, MA
This role will involve overseeing the adjustment of processes and the execution of projects in the domains of DNA, mRNA, saRNA, LNP formulation, and downstream procedures, including ultrafiltration, chromatography, and filtration.
- Design and implement innovative processes for xNA development in the realms of vaccines, gene therapies, and biosimilar applications.
- Provide technical expertise in xNA production, create detailed experimentation protocols, and organize and execute experiments within the designated scope of activities.
- Propose inventive technical solutions to achieve project goals, review run forms and raw data, and conduct preliminary analysis and interpretation of functional data.
- Present and report results to internal stakeholders and external clients.
- Ensure adherence to deadlines and project objectives within your assigned scope.
- Establish and maintain best practices for xNA operations, serving as an expert for the production of DNA, mRNA, saRNA, LNP formulation, and downstream processes, including UF, Chromatography, and filtration, in the RUO (Research Use Only) environment.
- Collaborate with stakeholders to determine Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for each product.
- Support interactions with external clients, actively engage with internal clients, and coordinate across various teams.
- Attend meetings for results presentation, provide technical feedback, insights, troubleshoot issues, and enhance operational efficiency.
- Emphasize customer-centric principles in all interactions and operations, ensuring the integration of these values into processes.
- For development activities, draft experimental protocols, study plans, and work-unit plans, ensuring that experiment data is captured in a format suitable for comprehensive reports.
- Write, update, and review Work Instructions (WI's), Standard Operating Procedures (SOP's), Batch Records (BR's), and Bills of Materials (BOM's) as needed.
- Serve as a Subject Matter Expert (SME) during client audits and take responsibility for the transfer from the process development team.
- Master's or Bachelor’s degree (or equivalent) in the fields of life sciences, chemistry, or biology.
- Recognized as an SME in xNA production.
- Demonstrates excellent communication skills, capable of sharing knowledge effectively and instilling confidence among colleagues.
- Displays innate curiosity, along with a dedication to continuous learning.
- Self-motivated individual with a strong interest in contributing to the growth of a rapidly expanding company.
- Appreciates a mindset focused on automated machines.
- Exhibits enthusiasm and adaptability to engage in diverse projects within a multitasking environment.
- Prioritizes a "Right First Time" approach and is customer-oriented.
- Functions effectively as a bench field person.