About this role
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.
Support routine process development and process characterization activities centered around the LNP drug product manufacturing process. Batch ranges vary from 10 mg to 1 gram.Execute routine analytics including dynamic light scattering (DLS), UV-quantification via Ribogreen®, pH, and osmolality for in-process monitoring.Perform experiments under limited to no supervision under subject matter expert guidance.Organize and analyze data, interpret results, and present findings within the process development team and cross-functionally.Author technical documentation (SOPs, reports, protocols) as required.Document experiments and protocols using electronic lab notebooks (e.g., Benchling).Maintain laboratory equipment, order critical reagents, and support operational excellence activities. Minimum Required Qualifications:
B.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. Proficiency in bench-scale drug product manufacturing of LNPs with a focus on mixing and tangential flow filtration (TFF) processes.Experience with practices and equipment used in process development of nucleic acids (experience with T-mixing and TFF is preferred).Experience with DLS and osmolality for in-process monitoring.Experience working with ELN systems such as Benchling.Experience with technical documentation (SOPs, technical reports, protocols).Ability to follow established SOPs for routine analytics.Ability to achieve results, keep to a timeline, and find solutions to ensure that overall project deliverables are met.Strong attention to detail, analysis of data/reports, troubleshooting, and problem-solving abilities.Strong writing and communication skills with the ability to understand and communicate scientific information.Strong organizational and time management skills.Willingness to collaborate with cross-functional teams.Proactive, creative, and positive attitude.Preferred Qualifications:
Experience with UV-quantification via Ribogreen®.Experience with GMP manufacturing practices and tech transfer operations is a plus.Experience with statistical analysis software (i.e. JMP, Design Expert, etc.) is a plus.Authorization 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:
Comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysEligibility for yearly goal-based bonus & merit-based increasesCompensation: $36.00-$42.00 per hourEurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.