Director, Process Chemistry

22h22 hours ago

Treeline Biosciences

Watertown, US · Full-time · $211,150 – $234,000

About this role

The Director of Process Chemistry is an experienced process chemist with a proven track record of successful process development, project leadership, and oversight of manufacturing small-molecule drug substances. You will handle process research, development, optimization, technical transfers, and manufacturing oversight at external partners up to process validation. This role includes document review, QA support, and regulatory writing for CMC portions of clinical and commercial submissions like INDs and NDAs.

Day-to-day involves collaborating with medicinal chemistry on candidate selection and developability, advising on sourcing scaffolds and intermediates. Provide technical leadership on drug substance process development and CDMO management, oversee tech transfers for supply continuity. Partner with analytical development for method validation and ensure timely batch record approvals.

Work cross-functionally with program teams, Quality Assurance, and CMC Regulatory in a fast-paced, science-driven environment. Design API production schedules for efficiency, input on deviation investigations, and implement cGMP controls. Manage multiple stakeholders and evolving priorities while staying current with global regulations.

Grow by authoring IND, IMPD, and marketing application sections, responding to agency inquiries. Lead complex timelines with budgeting understanding. Demonstrate commitment to excellence and patients through high integrity and collaboration.

Requirements

Ph.D. in Organic Chemistry or related discipline with 12+ years experience, or Master's with 15+ years, in CMC development organization.
Demonstrated successful leadership in pharmaceutical CMC drug substance development role.
Broad experience working with and managing external CDMO partners, including performance metrics and MSA negotiation.
Expertise in small molecule process development and oversight of GMP manufacturing, including tech transfer and process validation.
Experience authoring and reviewing technical documents including development reports, master batch records, analytical methods, and specifications.
Deep understanding of global regulatory requirements for manufacture, testing, and control of drug substances.
Demonstrated success authoring drug substance sections of INDs, IMPDs, marketing applications, and responding to agency inquiries.
Strong project leadership skills managing complex timelines, stakeholders, and priorities.

Responsibilities

Collaborate with medicinal chemistry partners to support candidate selection and developability assessments, advising on sourcing scaffolds and intermediates.
Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management.
Oversee technical transfer activities between CDMOs to ensure supply continuity.
Collaborate with Analytical Development to ensure development and validation of analytical test methods for drug substances.
Ensure timely documentation review and approval including batch records, specifications, and change controls.
Provide technical input to deviation investigations to assess impact on product and processes.
Partner with Quality Assurance and CMC Regulatory to develop processes and controls ensuring cGMP adherence.
Author and review technical documents, process development reports, and drug substance sections for INDs, IMPDs, and marketing applications.