Director of Analytical Development & CMC Strategy

ResumeXrays LLC; Emeryville (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Prolynx is seeking a Director of Analytical Development to lead assessment, qualification, validation, and implementation of analytical methods for preclinical and clinical programs.

The role requires developing a robust analytical strategy across starting materials, drug substance, and drug product, while guiding CROs/CDMOs and ensuring GMP readiness. Strong leadership and communication are essential for collaboration across regulatory and manufacturing teams.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Chemistry, or related field.
• 10+ years in pharmaceutical/biotech analytical development with increasing responsibility.
• Experience developing and implementing analytical methods for pharmaceutical products.
• Experience working with GMP laboratories and external analytical testing organizations.
• Strong written and verbal communication skills; ability to work in a cross-functional, fast-paced environment.

Responsibilities

• Lead analytical development strategy from preclinical through clinical development.
• Define analytical requirements for starting materials, drug substance, and drug product.
• Establish analytical control strategies aligned with product understanding and development stage.
• Provide analytical leadership for regulatory submissions (IND and beyond).
• Identify analytical risks and mitigation strategies.
• Oversee method development, qualification, and validation for complex molecules.
• Develop lifecycle strategies including transfer, qualification, validation, and monitoring.
• Drive external CRO/CDMO oversight and data evaluation.
• Collaborate with QA, Regulatory, Manufacturing, and Program Management.

Skills

Analytical development

Leadership

Regulatory submissions

Cross-functional collaboration

Problem solving

Communication

Education

Ph.D. in Analytical Chemistry

Tools

HPLC/UPLC

LC-MS

SEC

Peptide mapping

Ion-exchange chromatography

Spectroscopy

Job description

Prolynx is seeking a Director of Analytical Development to lead assessment, qualification, validation, and implementation of analytical methods for preclinical and clinical programs.

The role requires developing a robust analytical strategy across starting materials, drug substance, and drug product, while guiding CROs/CDMOs and ensuring GMP readiness. Strong leadership and communication are essential for collaboration across regulatory and manufacturing teams.