Process Development Senior Scientist

Key Responsibilities

• Serve as the Drug Product Team Lead and primary Drug Product functional representative on cross-functional synthetic molecule development teams
• Independently lead drug product development strategy and execution for early clinical synthetic molecule programs
• Lead and execute drug product development activities with a focus on right-first-time delivery, proactive risk management, and on-time achievement of program milestones.
• Design and execute formulation and process development experiments for oral solid dosage forms, including platform and enabling formulations
• Apply scientific understanding of material properties, biopharmaceutics, and manufacturability to formulation strategy selection and process development
• Identify technical risks, develop mitigation strategies, and drive solutions to support program timelines and clinical objectives
• Partner effectively across internal functions and external CMOs to support program execution, technology transfer, scale-up, and GMP clinical manufacturing
• Author and review technical and regulatory documentation including INDs, CTAs and related CMC submissions
• Present technical strategies, development plans, risks, and recommendations to cross-functional teams and governance forums
• Contribute to continuous improvement initiatives and advancement of formulation and process development capabilities

Basic Qualifications

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable]
• OR Masters degree and 3 years of Scientific experience
• OR Bachelors degree and 5 years of Scientific experience

Preferred Qualifications

• Ph.D. in Pharmaceutical Sciences, Bioengineering, Chemical Engineering, Chemistry, or related scientific discipline with emphasis on oral drug product development for advanced synthetic modalities including degraders and PROTACs.
• Industry experience supporting early clinical drug product development programs preferred.
• Hands-on experience with enabling solubility formulation technologies including hot melt extrusion (HME), spray dried dispersions (SDD), and downstream processing for oral solid dosage forms.
• Experience supporting oral solid dosage form process development, scale-up, technology transfer, and GMP clinical manufacturing.
• Strong understanding of formulation development for poorly soluble compounds and enabling bioavailability enhancement strategies.
• Experience serving as a Drug Product or Formulation Development representative on interdisciplinary and multidisciplinary teams.
• Experience authoring regulatory documentation including INDs, CTAs, and related RTQs.
• Excellent interpersonal and verbal/written communication skills with demonstrated ability to manage complex cross-functional project activities.