Director of Analytical Development & Regulatory Submissions

Planet Pharma; California (MO); On-site; USD 180,000 - 240,000; Full time

Job summary

Planet Pharma is seeking an Associate Director, Analytical Development to lead late-stage analytical strategy for a lipid-peptide inhalation product. You will oversee regulatory authoring, method development, and stability programs, working with CDMOs and internal teams to ensure robust data packages for BLA submissions.

Responsibilities include managing analytical development projects, directing method transfer/validation, and ensuring cGMP-compliant processes.

Qualifications

• Late-stage product development experience.
• Experience authoring CMC dossiers for FDA, EMA and other regulatory agencies.
• Bachelor's or Master's in Analytical Chemistry, Chemistry, Biochemistry, or related field.
• 5–10 years of product development experience.

Responsibilities

• Regulatory authoring and quality compliance for regulatory submissions (INDs, BLAs, NDAs).
• Manage analytical development projects for biologics, proteins, and peptides with CDMOs/Contract Laboratories.
• Develop and execute strategies aligned with company mission and regulatory standards.
• Manage method optimization, validation, and transfer for lipids, proteins, and peptides.
• Design and manage stability studies for NDA/BLAs and commercial shelf life.
• Coordinate with external manufacturing/analytical partners to meet timelines and quality expectations.
• Collaborate with R&D, Manufacturing, Regulatory, and QA teams.

Skills

Communication

Stability management

Regulatory knowledge

Technical expertise

Problem solving

Results oriented

Education

Bachelor's/Master's in Analytical Chemistry or related field

Tools

HPLC

LCMS

GCMS

Aerosol characterization

Viscosity/Particle Size

Job description

Planet Pharma is seeking an Associate Director, Analytical Development to lead late-stage analytical strategy for a lipid-peptide inhalation product. You will oversee regulatory authoring, method development, and stability programs, working with CDMOs and internal teams to ensure robust data packages for BLA submissions.

Responsibilities include managing analytical development projects, directing method transfer/validation, and ensuring cGMP-compliant processes.