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.
Qualifications
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.
Additional Information
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 options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Eligibility for yearly goal-based bonus & merit-based increases
- Compensation: $36.00-$41.00 per hour
