Hunter Chen Email & Phone Number

Tarrytown, Ny, Us

Tarrytown, New York, Us

• Directing drug product development for >30 assets comprising various modalities: monoclonal antibodies (mAb), bispecific antibodies, fusion proteins, siRNA, mRNA, LNP (CRISPR/Cas9), AAV, VLP.• Communicate effectively across multiple levels and foster strong collaborative relationships within departmental task forces, cross-functional teams, and external partners.• Actively participate in strategy planning meetings with senior management; make recommendations based on technical merit, competitive landscape, risk assessment, and alignment with company goals.• Manage relationships with strategic partners or CDMOs. Draft workplans, review proposals, timelines, and budgets. Support Business Development and Legal on contract negotiations.• Core member of CMC teams responsible for development and cGMP manufacturing activities across development lifecycle. Contribute to regulatory filings (IND, IMPD, BLA), responses to health authorities, technical reports, and technology transfer documents.• Subject matter expertise in IV, SC, ocular, and intrathecal delivery of biologics, gene therapy, fixed dose combinations, combination products (devices), controlled release formulations, and spray drying.• Identify innovative technologies to improve efficiency and enhance formulation capabilities.• Experience with IP due diligence and freedom-to-operate (FTO) to guide business decisions.

Tarrytown, New York, Us

• Lead team of Ph.D. and B.S./M.S. level scientists (5 direct reports; 1 co-op) responsible for developing formulations with biologics (mAb, fusion protein) and related manufacturing processes.• Direct technology development within department to add new capabilities to formulation, analytical, and delivery toolbox (controlled release, high dose/volume, viscosity reducer, novel devices for ocular delivery).• Collaborate with therapeutic focus areas (ophthalmology, hearing, infectious disease, allergy) and preclinical PK to overcome dosing challenges with formulation/delivery tools. • Collaborate with QC, Manufacturing, or Combination Device functions to introduce new technologies, processes, and devices in preparation for preclinical/clinical development.• Core member of CMC team responsible for advising on development activities and reviewing regulatory filings from strategic partners (Alnylam, Intellia, Decibel).• Partner with Finance to manage development budget ($1-2M).• Core member of task force that creates and implements best practices for department.• Co-authored patent applications, peer-reviewed manuscripts, and conference abstracts.Key accomplishments:• Successfully demonstrated cGMP readiness for aseptic spray drying of proteins. • Presented to senior management and received endorsement and budget approval to continue development work with external partner (Ocular Therapeutix).• Developed novel anhydrous platform process to encapsulate proteins into polymeric microspheres and microgels for controlled release. Filing 3 provisional patent applications.• Developed novel MCE-SDS method for heavily glycosylated proteins. Method is robust and suitable for QC purposes. Filing 1 provisional patent application.• Coaching talent on my team. Promoted 2 team members in 2019.• Acquired new capabilities for organization: SEM-EDS, membrane emulsification, NGI.

Tarrytown, New York, Us

• Proposed new projects and initiated investigation into new technologies that align with company lifecycle management strategies and goals. • Assumed leadership role in cross-functional teams with multiple external partners (Bayer, Ocular Therapeutix, and 8 undisclosed). Provided technical and strategic direction.• Expanded team to 5 direct reports. Recruited and trained Ph.D. and B.S. level scientists on best practices for executing workplans, operating within the organization, and collaborating with external partners.Key accomplishments:• Used DOE approach to identify two lead formulations for a biodegradable hydrogel implant for sustained release of protein in vitreous. Formulations met all in vitro target success criteria. Supported NHP toxicology and PK studies.• Demonstrated proof-of-concept for biodegradable hydrogel which sustained serum levels of mAb and efficacy (i.e. meaningful reduction in biomarker) for >6 weeks.• Peer-reviewed publication on novel stabilizing formulation for biodegradable reservoir device.• Acquired new capabilities for organization: SCISSOR subcutaneous simulator, Raman confocal microscopy, microfluidics.

Tarrytown, New York, Us

• Core member of cross-functional teams with strategic partner (Bayer) and managed multiple external collaborations (7 undisclosed).• Presented data to team and management. Contributed to decision-making process.• Surveyed landscape and guided future direction for new delivery technology research.• Trained and supervised Ph.D. intern and B.S. level scientist on best practices for conducting research and stability studies and operating safely in the lab.Key accomplishments:• Presented to Global Project Team and received endorsement to expand formulation activities and initiate critical preclinical animal studies with novel controlled release formulations/devices.• Presented at organization-wide scientific symposiums (Regeneron Science Day, Preclinical Development Technical Forum).

Tarrytown, New York, Us

• Developed sustained release formulations for proteins and related manufacturing processes.• Followed best practices for conducting research and stability studies: designing rigorous studies with controls, drafting protocols, analyzing data, and documenting results.• Authored technical reports or presentations tailored for target audience. • Supervised summer interns (2010, 2011) and informally mentored research associates.Key accomplishments:• Introduced new capabilities to organization: controlled release formulations, spray drying, microflow imaging.

• Analyzed IP for freedom-to-operate guidance for emerging technologies relevant to genetically modified organisms and large-scale biological culture systems.• Performed market research and generated report describing potential market opportunities and sizes. Recommended strategies to leverage existing portfolio and capture new market opportunities.

Boston, Ma, Us

• Worked with clients from pharmaceutical and medical device industries. Performed IP due diligence. Produced custom, searchable patent databases containing key attributes for FTO, M&A, and business development guidance.

Ph.D., Biomedical Engineering

M.S.E., Biomedical Engineering

B.S., Bioengineering