LateStage LNP Process Development Scientist

Eurofins USA PSS Insourcing Solutions; Boston (MA); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Bonus potential

Job summary

Eurofins USA PSS Insourcing Solutions seeks a scientist to support Late-Stage LNP process development, scale-up, and characterization for nucleic acid drug products. You will work in a collaborative team, refining process control and improving understanding across programs in clinical development.

Responsibilities include running analytics (DLS, pH, osmolality), data analysis, and documenting experiments with Benchling; strong writing and communication skills are essential.

Qualifications

• BS or MS with relevant lab experience in LNP or related fields.
• Proficiency with bench-scale drug product manufacturing of LNPs; experience with DLS and osmolality.
• Experience with ELN systems (Benchling) and technical documentation.

Responsibilities

• Support LNP process development and characterization activities.
• Perform analytics including DLS, UV quantification, pH, osmolality.
• Organize data, interpret results, and present findings to team.
• Author SOPs, reports, and protocols; document experiments in Benchling.

Skills

Lab research

Data analysis

Scientific communication

Time management

Education

Bachelor's degree in chemical/biomedical engineering, chemistry, or biological sciences

Master's degree in biological or biochemical sciences

Tools

Benchling

DLS

TFF equipment

Job description

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.

• 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.

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

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

Compensation: $36-$36