Jacob Irwin Email & Phone Number

Cary, NC, US

Palo Alto, California, US

- Lead of the process development group/function at BridgeBio Gene Therapy since July 2021, first as Associate Director and currently as Director. Responsible for AAV-based gene therapy upstream and downstream process development, scale-up, scale-down, tech transfer, and cGMP SME manufacturing support.- Manage a team of 9 total direct and indirect reports.

Palo Alto, California, US

Responsible for the AAV-based gene therapy upstream, downstream, and innovation process development functions at BridgeBio Gene Therapy.

Palo Alto, California, US

- Served as lead for the downstream process development group/function at BridgeBio Gene Therapy from October 2019 - July 2021. - Responsible for AAV-based gene therapy downstream process development, scale-up, tech transfer, and cGMP manufacturing support.- Served as sponsor/client person-in-plant (PiP) representative during FIH clinical trial.

• Created and published a successful personal finance blog, focusing on topics such as frugal living, Modern Portfolio Theory, asset allocation, and index mutual fund investing.
• Business model is to receive advertising income using Google Adsense, affiliate, and direct sponsorship methods.
• Blog features over 1700 individual published articles, has attracted >500k visitors, and 1000 email subscribers.
• Oversaw a team of 15 staff writers to author articles for the site to provide consistent content for readers.
• Enabled me to refine my skills in marketing, website and community building, negotiation, business taxation, and technical writing.

Durham, North Carolina, US

• Therapeutic protein, vaccine, and antibody biologics purification PD, characterization, optimization, scale-up/down, and internal/external tech transfer for plant-scale manufacturing.
• Technical lead for one late-stage / commercial biologic program.
• Downstream PD functional area lead (FAL) for three early stage (Phase 1, First-In-Human [FIH]) therapeutic protein and vaccine programs.
• Managed three downstream process development scientists and trained five others.
• Authored proposals/change orders resulting in $1.5MM+ of projects.
• Solubilization, refold, clarification (depth/membrane filtration, acid precipitation), UF/DF final formulation, and protein A/L affinity, hydroxyapatite (HA/CHT), benzamidine, ion exchange (CEX and AEX), membrane, and.

Charlottesville, VA, US

• Investigated novel drug candidates for Alzheimer's Disease treatment and the mechanisms by which they act.
• Evaluated the ability of three small molecules (brilliant blue G, and erythrosine B, and methylene blue) to both modulate and reverse the aggregation of amyloid-beta protein aggregates, a hallmark of Alzheimer’s Disease.
• Characterized the effect of the three small molecules and their structural analogs on amyloid-beta protein aggregate secondary structure (circular dichroism), morphology (TEM and AFM), antibody reactivity, kinetics.
• Initiated, authored, learned regulations, and gained approval for a mouse animal use protocol through the Institutional Animal Care and Use Committee at UVa.
• Evaluated the efficacy of the small molecules to cross the blood-brain barrier and ameliorate the pathological hallmarks of Alzheimer’s disease in an in vivo transgenic mouse model.
• Assisted in authoring NIH, NSF, and Alzheimer’s Association grant proposals.

Charlottesville, VA, US

• Assisted licensing staff in assessing the appropriateness and scope of intellectual property protection for invention disclosures from University researchers by performing prior art searches, drafting non-confidential.
• Performed 30 prior art searches / patent landscape analyses for new invention disclosure technologies from University researchers. Subject matter of inventions ranged from small-molecule, protein, and cell-based health.
• Identified companies and sub company contacts for potential licensees.
• Conducted reviews of current patentability guidelines for animal models and drug targets/mechanisms of actions

Rahway, New Jersey, US

• Served as Recombivax (Hepatitus B vaccine) analyst in Merck’s global vaccine supply chain group.
• Allocated ~$70MM of Recombivax product to all global customers (US, Canada, Latin America, EU, and Asia) and evaluated $1MM of franchise growth opportunities.
• Built and utilized long-term bulk Recombivax supply model to analyze demand and determine if franchise growth was possible.
• Utilized Six Sigma tools to streamline vaccine supply communications issued to Merck senior leadership. Provided an optimized solution report template to reduce man-hours for compiling reports by 50%.
• Conducted supply chain node vulnerability analysis for all vaccine raw materials to determine which materials/suppliers presented the most risk to end-market supply.

Rahway, New Jersey, US

• Served as co-skid lead for Ultrafiltration (protein disassembly, reassembly, and buffer exchange) step during start-up and process validation demonstration of new HPV Gardasil protein purification facility (tech.
• Authored clean room cleaning procedures and facilitated room qualification/room hygiene performance qualification.
• Provided troubleshooting to Delta V recipes to optimize filtration and purification performance of each vaccine lot.
• Lead cleaning validation for ultrafiltration skid equipment, including swabbing, rinsate sampling, and TOC analysis.
• Utilized Lean Six Sigma tools in Green Belt Project to assign weighment tolerances to biologics raw material weighing and dispensing facility – Project valuation: $72,848 in labor expense cost structure efficiency..
• Served as a mentor for three summer interns, one rotational analyst, and one full-time engineer.

Rahway, New Jersey, US

• Addressed and corrected potential cGMP compliance gaps in Primaxin bulk antibiotic sterilization facility.
• Authored atypical, deviation, and environmental monitoring Trackwise investigations to facilitate the release of associated sterile lots.
• Served as project lead for MK-7655 Beta Lactamase (antibiotic resistance) inhibitor filling project for Merck Research Labs Phase I clinical trials. Gained experience in clinical trial requirements and methods.
• Primaxin Sterile Milling Process Train (intramuscular injection formulation)o Gained 1st line supervisory experience by overseeing and troubleshooting sterile antibiotic milling campaign.

Doctor Of Philosophy (Phd), Chemical Engineering

Master Of Science (Ms), Chemical Engineering

B.S, Honors, Biological Engineering

B.S, Finance

Minor, Spanish