BioCryst Pharmaceuticals, Inc. · 2 days ago
Director, Drug Product Development
United States
Full-time
Remote
Director/Executive
10+ years expBioCryst Pharmaceuticals, Inc. is committed to improving the lives of people living with hereditary angioedema and other rare diseases. The Director of Drug Product Development will lead formulation and process development for patient-centered parenteral drug products, overseeing all aspects of biologics drug product development from early discovery to commercialization.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Provide scientific, technical and operational leadership for formulation, process development and manufacturing of patient-centered, injectable drug products for BioCryst’s portfolio from pre-clinical to successful licensure, primarily through external partners
Develop drug product development strategies through internal/external partnerships and product integration into drug/device combination products
Enable the progression of BioCryst’s biologics portfolio that currently includes protein-based modalities as liquid and lyophilized dosage forms in vial, prefilled syringe, and cartridge-based presentations
Drive the product development efforts in a phase-appropriate manner defining formulation, manufacturing process, container/closure for clinical trials and towards commercialization
Lead interactions with external partners to drive the above activities. Maintain close collaboration with internal program leaders and stake-holders
Support organization and program leaders in developing budgets, timelines, tracking progress as well as risk identification, communication and mitigation
Provide subject matter expertise for technical due diligence and for the technical as well as strategic content of the relevant drug product sections of regulatory submissions
Author and review high-quality development reports, technical summaries and other documentation to support product development
Mentor and develop colleagues to internal and matrix teams, contributing to a high-performing pharmaceutical sciences organization
Stay current with evolving CMC and global regulatory strategies for biologics and small-molecule programs through literature and external networking, ensuring alignment with industry best practices and regulatory expectations
Performs other duties as assigned
Qualification
Required
MS / PhD in Bio/Chemical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with at least 10 years of relevant field experience in end-to-end biologics drug product development (encompassing formulation, process development, scale up, technology transfer and manufacturing support). A significant part of this experience must include directing and managing development with external partners
Must be proficient in current approaches for formulation and drug product process development, manufacturing processes and equipment, regulatory expectations and applying these to developing efficient approaches to ensure product licensure
Experience with high concentration protein formulation development, aseptic processes, vial, prefilled syringe, cartridge presentations, liquid and lyophilization dosage forms is a must
Knowledge of current regulatory guidelines and cGMP requirements is necessary
Must have a strong grounding in biochemistry / biophysics to ensure a science-driven approach to biologics product development
Demonstrated experience supporting regulatory submissions and interacting with Analytical, Quality and Regulatory functions
Proven ability to manage external partners and deliver results in a fast‑paced biotech environment
Excellent written and verbal communication skills, including experience authoring technical reports and regulatory documentation
Company
BioCryst Pharmaceuticals, Inc.
BioCryst Pharmaceuticals is a commercial-stage biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.
501-1000 employees
H1B Sponsorship
BioCryst Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
100%
Represents job field similar to this job
Engineering and Development
Trends of Total Sponsorships
*2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.79BKey Investors
Ontario Municipal Employees Retirement System,Royalty PharmaAthyrium Capital Management LP,Royalty PharmaMidCap Financial
2023-04-17Post Ipo Debt· $450M
2021-11-22Post Ipo Equity· $350M
2020-12-07Post Ipo Debt· $325M
Leadership Team
Charlie Gayer
President and Chief Executive Officer
Nancy Hutson
Chair
Recent News
2026-08-05
2026-07-07
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-07-01
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