Job Details

BioPharma Company

Seeking an experienced scientist to lead the development of oral drug formulations, particularly oral peptides, from early discovery through clinical stages. This leadership role involves overseeing internal teams and external contract development and manufacturing organizations (CDMOs), managing preformulation activities, and supporting regulatory submissions globally.

Key Responsibilities

• Lead and mentor scientists in oral peptide formulation development.
• Oversee outsourced formulation development and manage CDMO relationships.
• Direct preformulation and formulation research, ensuring scalability and tech transfer readiness.
• Contribute to regulatory filings (INDs, IMPDs, NDAs) and manage clinical supply production.

Required Expertise

• Extensive knowledge of oral dosage forms and formulation techniques (e.g., tablets, capsules, lipid-based systems, nanoparticles, etc.).
• Strong background in preformulation and formulation characterization (solubility, stability, drug loading, release profiles).
• Familiarity with cGMP principles and CDMO oversight for oral drug manufacturing.
• Proficiency in analytical techniques (HPLC, DSC, PXRD, etc.) used for drug and formulation analysis.
• Understanding of oral peptide delivery challenges and solutions.

Qualifications

• MS or PhD in a relevant scientific field with 10+ years of experience in oral drug development.
• Proven leadership skills in both scientific and cross-functional team settings.
• Excellent communication, project management, and organizational abilities.
• Willingness to travel for CDMO oversight and tech transfers.