Director of Analytical Development & QC Excellence

Treeline; Watertown (MA); Presencial; USD 194.000 - 233.000; Tempo integral

Resumo da vaga

Treeline Biosciences is seeking a Director of Analytical Development & Quality Control in Watertown, MA. This leader will shape analytical strategies for small molecule OSDS and parenteral programs, coordinating with internal teams and outsourced partners to enable development through commercialization.

The role requires deep expertise in analytical method development, validation, transfer, and QC oversight, plus collaboration with Regulatory Affairs and QA, to meet global GMP expectations and

Qualificações

• Ph.D./MS in Analytical Chemistry or related field preferred.
• 12+ years (Ph.D.) or 15+ years (MS) of analytical development experience.
• Experience with analytical methods for drug product development and manufacturing (oral solid dose, parenteral, pediatric).
• Proven track record with CDMOs and global partners.

Responsabilidades

• Lead phase-appropriate analytical method development and testing strategies for Drug Product development.
• Oversee external GMP testing, release testing, stability, and QC activities.
• Author and review analytical sections of regulatory submissions (INDs, NDAs, BLAs).
• Manage external partnerships with CDMOs/CMOs and oversee method transfers and validation.

Conhecimentos

Analytical method development

Validation

Quality control leadership

Regulatory submissions

CDMO collaboration

Formação

Ph.D. in Analytical Chemistry

MS in Analytical Chemistry

Ferramentas

HPLC/UPLC

LC-MS

iStability

JMP

Descrição da vaga

Treeline Biosciences is seeking a Director of Analytical Development & Quality Control in Watertown, MA. This leader will shape analytical strategies for small molecule OSDS and parenteral programs, coordinating with internal teams and outsourced partners to enable development through commercialization.

The role requires deep expertise in analytical method development, validation, transfer, and QC oversight, plus collaboration with Regulatory Affairs and QA, to meet global GMP expectations and