Director, Analytical Development & QC for ADCs

Treeline Biosciences; Watertown (MA); On-site; USD 194,000 - 233,000; Full time

Job summary

Treeline Biosciences in Watertown, MA, seeks a Director of Analytical Development & Quality Control to provide strategic leadership for analytical development, method validation, transfer, and QC activities across small molecule and ADC programs, in a 100% outsourced environment.

This role partners with Drug Substance, Drug Product, Regulatory Affairs, QA, and external CDMOs to ensure regulatory-ready analytics, CGMP compliance, and scalable testing capabilities through development to

Qualifications

• Ph.D./MS with extensive pharma/biotech analytical experience.
• Experience leading analytical development for small molecules and biologics/ADC.
• Proven track record with CDMOs and global partners.

Responsibilities

• Provide strategic leadership for analytical development, method validation, transfer, and QC activities.
• Lead external testing oversight, including GMP release and stability programs.
• Develop CQAs and control strategies; support regulatory submissions and inspections.
• Manage external partners and technology evaluations to meet timelines.

Skills

Analytical method development

Quality control leadership

CDMO collaboration

Project management

Regulatory knowledge

Education

Ph.D. in Analytical Chemistry or related field

MS in Analytical Chemistry or related field

Tools

HPLC/UPLC/LC-MS

SEC/CE-SDS

ICH guidance familiarity

Job description

Treeline Biosciences in Watertown, MA, seeks a Director of Analytical Development & Quality Control to provide strategic leadership for analytical development, method validation, transfer, and QC activities across small molecule and ADC programs, in a 100% outsourced environment.

This role partners with Drug Substance, Drug Product, Regulatory Affairs, QA, and external CDMOs to ensure regulatory-ready analytics, CGMP compliance, and scalable testing capabilities through development to