mRNA Drug Product Development- Process Team Scientist

Category:

Life Science

Employment Type:

Contract

Reference:

BH-389096

mRNA Drug Product Development- Process Team Scientist
needed for a contract opportunity with Yoh Scientific's client located in Waltham, MA.

This position is in the Drug Product Development Group
of a major pharmaceutical company. Schedule is full-time M-F (7am-8am start time, 8 hour shift)
and may require flexibility to work some evenings and overtime due to projects.

Key Responsibilities:

• Lead the formulation optimization and/or process understanding of mRNA-containing lipid nanoparticle (LNP) formulation and production processes encompassing a wide range of different mRNAs and novel lipids.
• Work closely with the Research team in transferring and accelerating new LNP composition formulation into CMC development.
• Design and conduct small-scale multi-component LNP formulating experiments to understand the developability of new LNP formulations.
• Lead the compilation of Developability package for new LNP formulations.
• Develop initial formulation process for new LNP formulations.
• Performing in-process drug product characterization.
• Perform complex and routine analytical methods to characterize new formulations and to troubleshoot as needed.
• Coordinate/Suggest/Introduce advanced LNP characterization analysis with the Analytical Sciences department.
• Support the Drug Product team to troubleshoot technical, formulation, and processing issues.
• Document development study set up, results, and conclusions within an electronic lab notebook.
• Tabulating and analyzing in-process and post-process characterization data.
• Summarize and present study progress, generated data, and analysis to other scientific team members and larger group meetings.
• Supporting the growth and expansion goals by setting up and installing new characterization and process equipment into new laboratories.

• Ph.D. in Chemical Engineering, Biomedical Engineering, Chemistry, Biophysics, Pharmaceutical Sciences, or a related scientific discipline; or
• Bachelor's or Master's degree in Engineering (e.g., Chemical, Biomedical, or related field) with demonstrated experience in lipid nanoparticle (LNP) formulation and/or process development.
• 0 to 3 years of post-doctoral or professional experience in formulation and/or process development
• Strong scientific understanding of formulation and process development in pharmaceutical related environment.
• Strong organizational and communication skills with the ability to work and communicate cross-functionally.
• General understanding of common LNP production process and analytical characterization techniques is desirable, prior experience running these techniques is a plus.
• Desire to work in a fast-paced environment.
• Strong organizational and communication skills with the ability to work and communicate cross-functionally.
• Ability to be flexible and responsive to change, be a results-driven problem solver.

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities