Senior Analytical Development & Quality Control Scientist

The Analytical Development and Quality Control Scientist within mRNA Center of Excellence provides end-to-end support to the development and manufacturing of mRNA vaccines. 

Essential Duties and Responsibilities

• Analytical Development & Quality Control Sr. Scientist is required to support the following activities: Study - Own and drive the analytical methods development qualification and validation for raw materials internally and at CROs.
• Support the organization Manager with data for the definition of specifications and testing profiles. Analytical support for process development of custom (In Process Controls and In Process Monitoring). Communication with client mRNA Center of Excellence analytical development and quality control leaders.
• Activity - Ensure analytical data certificates of analysis and reports are available on time. Review strategy protocol and reports.
• Manage compendial method verifications and stay abreast of compendial method updates.
• Support contract research organization release and stability testing and other GMP activities including Change control deviation and OOS investigation and ensure proper CAPA (Corrective and Preventative Actions) implementation.
• Collaborate with the contract research organization Manager RM leader Stability Manager Subject Matter Experts and other project managers to align the timeline.
• Provide data and reports testing strategy. Follow up with generation and approval.
• Perform in-house method development and testing. Planning initiation execution and tracking of project activities. Proactively monitor project progress and provide timely communications to the leadership team.

Successful raw material methods development qualification and validation as well as testing will ensure timely raw material release internally and at contract research organizations and thus support successful mRNA vaccine manufacturing to be on time enabling our fast-track mRNA Center of Excellence investigational new drug goals.

Other Duties

Work scope requires support for mRNA QC analytical method development and material testing supporting Analytical Development CMC activities for preclinical through late-stage development programs. Deliverables to support both internally and externally at CRO for various analytical CMC activities include:

• Own/drive analytical methods development qualification and validation.
• Perform analytical testing and data review of batch release in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory.
• Executes routine procedures based on biochemistry methodologies such as HPLC UPLC SoloVPE.
• Executes routine procedures based on bioassay methodologies such as plate based assays (ELISA ddPCR ribogreen).
• Support the laboratory start-up activities participate in validation activities.
• Authors revisions to SOPs for managerial review and approval.
• Executes troubleshooting with minimal guidance from supervisor or senior team members.
• Acts as trainer for specific methodology responsibile for training less experienced analysts on assays of expertise.
• Support Equipment Validation activities.
• Support qualification and validation testing of QC methods in area of expertise.
• Support and/or lead lab investigations deviations change control.
• Participate in continuous improvement of laboratory safety and quality compliance

Qualifications :

Required Education Experience Skills and Certifications

• Bachelors degree in biological sciences
• Demonstrated ability to contribute to scientific discussions and drive new technical project progress to target the goal.
• Strong organizational and communication skills with a high attention to detail
• Able to conduct experiments and analyze data independently
• Strong time management skills
• Good team player
• Skilled at managing multiple priorities and building strong cross-functional relationships
• Able to help maintain various lab instruments
• Proficiency in Microsoft Office (PowerPoint Excel Word)

Preferred Education Experience Skills and Certifications

• Experience using an electronic lab notebook
• Experience updating electronic sample inventory management systems
• Experience communicating results in small group meetings and/or in reports
• Experience with liquid chromatography and/or mass spectrometry
• Comfortable working under tight timelines and in evolving organizational environments

Work Authorization/Security Clearance Requirements

• Must be cleared to work at client site

Additional Information :

Positions are full-time working Monday-Friday 8am-5pm overtime as needed. Candidates currently  living within commutable distance to Waltham MA  are encouraged to apply.

Excellent full time benefits including comprehensive medical coverage dental and vision options

• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time