David Schwalb Email & Phone Number

Tampa, Florida, Us

● Development and execution of analytical strategy for PCRX-201 HCAd gene therapy program. ● Management of external and internal analytical assay development including; novel product specific potency assays, critical optimization of early phase assays, and phase appropriate development. ● Oversight and coordination of release testing and collaboration with process and quality teams to ensure disposition of manufactured DS and DP.

Tampa, Florida, Us

● Technical transfer and integration of Flexion CGT program to Pacira as part of acquisition. ● Lead analytical and/or process investigations and SME partner for contract organization audits. ● Lead and mentor analytical development scientists.

Cambridge, Massachusetts, Us

● Management of the analytical development and process analytics team. Assays utilized various chromatography, proteomic, qPCR/ddPCR, and biophysical applications.● Research to development (R2D) planning and oversight for analytical and process development transitions. ● Analytical representative on early and clinical stage CMC teams.

Somerville, Massachusetts, Us

● Management of the gene therapy drug product analytical development team. Responsibilities include development, qualification, and life cycle management of drug product in-process, characterization, and release assays. Assays utilized various chromatography platforms, mass spectrometry, enzymatic, proteomic, and biophysical applications.● Analytical development representative for bluebird bio portfolio for all clinical and commercial investigations.● Management of analytics and process development for small molecule transduction enhancer manufacturing and regulatory documentation.● Analytics representative for severe genetic disease candidate(s) CMC team. Responsibilities include contribution to planning and execution of early stage development and communications with agencies.● Developed bluebird bio cross platform potency assay strategy for multiple regulatory agencies.● Participate and aid in regulatory filings and responses for both the EMA and FDA.● Direct oversight of five individual scientists, matrix leadership of cross functional teams, and extensive CxO management.

Somerville, Massachusetts, Us

Team lead for cellular analytics assay development and CRO collaboration for gene and cellular therapy applications.

Boston, Massachusetts, Us

● Designed and evaluated methodologies in support of the development of protein therapeutics.● Collaborated with regulatory teams to address PMC’s and communicate responses and data.● Developed and compared assays to measure and evaluate kinetics and other key parameters required by the regulatory agencies.● Designed methodologies to detect and quantify HCP’s for ongoing protein production efforts.● Cultivated technical experience with automated liquid handling systems and cell culture of primary and immortalized cell lines.

Basel, Baselstadt, Ch

As part of chemical genetics team, developed methods for small molecule affinity enrichment techniques utilizing a customizable matrix coupled to investigative compounds to enrich for unknown target proteins within custom lysates for detection by mass spectrometry.

Ms, Biochemistry

Bs, Biology / Communications