Full Job Description
As a member of the Late-Stage LNP Process Development team, the candidate will be joining a team conducting laboratory studies to support the process development, process scale-up, and process characterization of LNP clinical stage drug products. The successful candidate will have experience with LNP process development (having additional experience in tech transfer and GMP manufacturing is a plus but not required), and a desire to contribute to a team focused on establishing science-based manufacturing solutions for complex nucleic acid-based drug products. In this highly collaborative and cross-functional role, the candidate will support the refinement of process control and improve process understanding for multiple programs at various stages of clinical development.
37Support routine process development and process characterization activities centered around the LNP drug product manufacturing process. Batch ranges vary from 10 mg to 1 gram.37Execute routine analytics including dynamic light scattering (DLS), UV-quantification via Ribogreen ae, pH, and osmolality for in-process monitoring.37Perform experiments under limited to no supervision under subject matter expert guidance.37Organize and analyze data, interpret results, and present findings within the process development team and cross-functionally.37Author technical documentation (SOPs, reports, protocols) as required.37Document experiments and protocols using electronic lab notebooks (e.g., Benchling).37Maintain laboratory equipment, order critical reagents, and support operational excellence activities.
Minimum Required Qualifications:
37B.S. degree in chemical/biomedical engineering, chemistry, or biological sciences (or related field) with 3-4 years of relevant laboratory experience. M.S. degree in biological or biochemical sciences (or related field) with 1-2 years of relevant laboratory experience.
37Proficiency in bench-scale drug product manufacturing of LNPs with a focus on mixing and tangential flow filtration (TFF) processes.
37Experience with practices and equipment used in process development of nucleic acids (experience with T-mixing and TFF is preferred).
37Experience with DLS and osmolality for in-process monitoring.
37Experience working with ELN systems such as Benchling.
37Experience with technical documentation (SOPs, technical reports, protocols).
37Ability to follow established SOPs for routine analytics.
37Ability to achieve results, keep to a timeline, and find solutions to ensure that overall project deliverables are met.
37Strong attention to detail, analysis of data/reports, troubleshooting, and problem-solving abilities.
37Strong writing and communication skills with the ability to understand and communicate scientific information.
37Strong organizational and time management skills.
37Willingness to collaborate with cross-functional teams.
37Proactive, creative, and positive attitude.
Preferred Qualifications:
37Experience with UV-quantification via Ribogreen ae.
37Experience with GMP manufacturing practices and tech transfer operations is a plus.
37Experience with statistical analysis software (i.e. JMP, Design Expert, etc.) is a plus.
37Authorization to work in the United States indefinitely without restriction or sponsorship.
The position is full-time, Monday-Friday, 8am-5pm with overtime as needed. Candidates living within a commutable distance of Boston, MA are encouraged to apply.
Excellent full-time benefits include:
37Comprehensive medical coverage, dental, and vision options
37Life and disability insurance
37401(k) with company match
37Paid vacation and holidays
37Eligibility for yearly goal-based bonus & merit-based increases
37Compensation: $36.00-$41.00 per hour