A biotech company in Cambridge is looking for a Director of Analytical Development to lead strategies for ADC programs. The successful candidate will establish robust analytical platforms and manage cross-functional collaborations. A PhD in a relevant field and over 10 years of experience in analytical development, particularly with ADCs, are essential. Strong leadership and regulatory compliance knowledge are key for this role, which involves managing external resources and contributing to regulatory submissions.
Qualifications
10+ years of industry experience in analytical development for biologics.
Direct experience with ADCs is required.
Strong knowledge of ICH guidelines and regulatory expectations.
Responsibilities
Lead and execute analytical development strategies for ADC programs.
Oversee analytical method development and validation.
Manage external CRO/CDMO partnerships.
Skills
Analytical method development
Biologics and ADC analytical characterization
Leadership skills
Regulatory compliance knowledge
Strong communication skills
Education
PhD in Analytical Chemistry, Biochemistry, or related field
Tools
SEC-MALS
CE-SDS
icIEF
HIC
Job description
A biotech company in Cambridge is looking for a Director of Analytical Development to lead strategies for ADC programs. The successful candidate will establish robust analytical platforms and manage cross-functional collaborations. A PhD in a relevant field and over 10 years of experience in analytical development, particularly with ADCs, are essential. Strong leadership and regulatory compliance knowledge are key for this role, which involves managing external resources and contributing to regulatory submissions.