• PhD in the biology or chemistry-related disciplines and 10+ years industry experience or a BS/MS and 15+ years industry experience.
• Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products.
- Lead a team of 2 – 3 scientists in the Drug Product group of Process and Manufacturing Sciences.
- Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation.
- Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work.
- Written and oral communication. Authoring of protocols, reports and parts of regulatory filings. Internal and external presentations.
- Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements.
- Solid understanding of cGMPs and compliance requirements.
Prior experience interacting with the FDA during inspections.