Director, Analytical Development & CMC Strategy

4:59 Initiative; United States; In loco; USD 225.000 - 275.000; Tempo pieno

Descrizione del lavoro

4:59 Initiative is seeking an experienced leader to drive analytical development across the pipeline from preclinical to clinical stages. The role demands oversight of method development, validation, and lifecycle management with emphasis on GMP readiness and regulatory submissions.

The candidate should bring deep expertise in analytical chemistry for biopharmaceuticals, strong cross-functional leadership, and a track record of delivering robust analytical controls and strategies aligned with

Competenze

• Ph.D. in Analytical Chemistry or related field.
• 10+ years in analytical development within pharma/biotech.
• Experience developing and implementing analytical methods for pharmaceutical products.
• Experience with GMP laboratories and external analytical testing organizations.
• Excellent written and verbal communication; ability to work cross-functionally.

Mansioni

• Develop and execute the analytical development strategy from preclinical to clinical development.
• Define analytical requirements for starting materials, drug substance and product.
• Establish analytical control strategies aligned with product understanding and development stage.
• Provide analytical development leadership for CMC activities supporting regulatory submissions (IND and clinical filings).
• Identify analytical risks and develop mitigation strategies.
• Lead development, qualification, and validation of analytical methods for complex molecules.
• Lead characterization strategies for peptide- and PEG-containing molecules.

Conoscenze

Analytical development

Method development

Regulatory submissions

Cross-functional collaboration

Data interpretation

Communication

Leadership

Formazione

Ph.D. in Analytical Chemistry

10+ years industry experience

Strumenti

HPLC/UPLC

LC-MS

SEC

Ion exchange chromatography

Peptide mapping

Descrizione del lavoro

4:59 Initiative is seeking an experienced leader to drive analytical development across the pipeline from preclinical to clinical stages. The role demands oversight of method development, validation, and lifecycle management with emphasis on GMP readiness and regulatory submissions.

The candidate should bring deep expertise in analytical chemistry for biopharmaceuticals, strong cross-functional leadership, and a track record of delivering robust analytical controls and strategies aligned with