Director, Drug Product Development

About the role

The Director of Drug Product Development will lead and direct formulation and process development for patient-centered parenteral drug products supporting BioCryst’s biologics portfolio. This role is responsible for development of portfolio projects in a phase-appropriate manner while working with external Contract Development and Manufacturing Organizations (CDMOs).

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 stakeholders.
• 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.

Qualifications

• 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.