Jon Harper Email & Phone Number

Raleigh, Nc, Us

Raleigh-Durham, North Carolina Area

Research Triangle Park, Nc

• Led analytical activities for developmental inhaled therapeutic program. Responsibilities included technical/HR management of a junior staff member, week-to-week management of analytical activities, assay troubleshooting, and representing Liquidia in meetings with external partners.• Provided analytical support for a developmental vaccine program. Responsibilities included developing and transferring analytical methods, analyzing samples, interpreting and communicating data to stakeholders, and representing Liquidia in meetings with external partners.• Transferred in an HPAE-PAD method for analysis of a polysaccharide vaccine. Successfully adapted/troubleshot the assay to function on a traditional HPLC rather than an ion chromatography system.• Developed/transferred in a titrimetry method for determining acid content of a copolymer. This assay and the HPAD-PAD assay allowed the project team to provide compelling data to an external partner on feasibility of the vaccine program.• Executed and assisted as technical leader on other assays including RP-HPLC (content and impurities), GPC, FT-IR, and next generation impaction.• Collaborated with peers on teams focused on improving procurement of laboratory supplies and scheduling of HPLC/UPLC instruments.

Research Triangle Park, Nc

• Managed multiple responsibilities including developing, transferring, qualifying, and validating analytical assays, interpreting and communicating data to stakeholders (cross-functional team members, management and clients), authoring technical documents (protocols, reports, and test methods) and managing departmental inventory of chemicals and supplies.• Represented the analytical development group on multiple teams/committees (sustainability, emergency response, candidate selection and procurement improvement). As part of the procurement improvement committee, presented findings to the senior leadership team. Recommendations were adopted, leading to a reduction in the average reagent lead time in the analytical and process development departments from more than two weeks to one week.• Identified N-linked glycan and monosaccharide profiles of a glycoprotein, including the implementation of a new (to the company) approach to monosaccharide analysis.• Transferred and qualified quantitative SDS-PAGE and Bioanalyzer methods on a compressed timeline despite significant technical challenges. Successfully performed troubleshooting of both assays, including working with the quality control group when challenges arose with the SDS-PAGE assay (helping the company realize over $500,000 in revenue for a major stability study).• Supported forced degradation and stability studies for multiple projects with a 100% rate of meeting due dates.• Supported implementation of a new microfluidic electrophoresis instrument which included coordination/ordering of accessories and external products, receiving external training and serving as an SME for colleagues using the instrument.• Adapted an existing SEC purity method for concentration determination. Planned, executed, analyzed and communicated data for a qualification-like study within 48 hours of request.

Research Triangle Park, Nc

• Responsibilities included developing, and validating analytical assays, performing release and stability testing, interpreting and communicating data to stakeholders (cross-functional team members and clients), and authoring technical documents (protocols, reports, test methods, and standard operating procedures).• Developed analytical procedures for testing product quality of inhalation products including HPLC, delivered dose, cascade/next generation impaction, particle/droplet size analysis, and FT-IR. • Led a cross-functional team in streamlining procedures for all phases of the cleaning verification process. Achievements included significant reductions in repeat analyses and improved turnaround times. Presented progress weekly to senior leadership team.• Developed a novel approach for performing cleaning verification of a highly labile molecule. Created a poster based on this work that was presented at a major conference.• Managed all aspects of a small-scale forced degradation study including sample stressing, analytical testing, and results reporting.• Created and executed a strategy for dose and cascade impaction testing for a nebulized drug product which was a first for the department.