Sr. Principal Scientist, Oral Drug Product Development

Director, Oral Drug Product Development Responsibilities:

• Lead formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage forms across all stages of development.
• Develop enabling formulation approaches for challenging compounds (poorly soluble, poorly permeable, unstable, or complex molecules such as orally delivered peptides).
• Serve as the senior drug product representative on cross‑functional CMC and asset teams; align regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.
• Influence portfolio decisions based on develop ability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.
• Champion technology transfer, clinical manufacturing readiness, and scale‑up at internal and external manufacturing sites; provide strategic oversight and establish manufacturing strategies.
• Mentor and develop scientists and engineers supporting oral drug product development.
• Oversee completion of drug product sections for regulatory submissions and related technical documentation.
• Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices to improve development efficiency and portfolio execution.

• PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline; minimum 12 years' oral drug product development experience.
• Track record leading formulation and process development for oral solid dosage forms (early through clinical manufacturing and/or late‑stage).
• Experience with scale‑up, technology transfer, clinical manufacturing, and external manufacturing organizations.
• Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase‑appropriate development strategies.
• Ability to lead cross‑functionally, influence strategy, manage technical risk, and communicate effectively.
• Experience mentoring, developing, or leading scientists and engineers.

• Enabling tech expertise (amorphous solid dispersions, spray drying, hot‑melt extrusion, lipid‑based formulations, modified release, particle engineering).
• Late‑stage development, commercial readiness, process characterization, and/or process validation experience.
• Experience supporting at least one NDA/MAA and regulatory agency interactions.
• Hands‑on oral solid dose manufacturing unit operations and manufacturability experience.
• Experience implementing new technologies/digital tools/knowledge platforms across programs.
• Experience managing external CDMO/CMO relationships and technology transfer.

• Medical, Dental, Vision, & Life insurances; fitness & wellness (reimbursement); short- and long-term disability; paid vacation (15+ days) and end‑of‑year shutdown; paid holidays; sick time; paid maternity and parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year);
  Employee Resource Groups participation.