Director, Chemical Development

Treeline; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Treeline seeks a Director, Chemical Development to lead development and manufacturing activities for drug substance and starting materials within a 100% outsourced model. The role covers process development, scale-up, PPQ, and collaboration with CDMOs to ensure supply continuity and regulatory readiness for IND/IMPD submissions.

The candidate will oversee cross-functional teams, drive technical transfer, ensure QA and regulatory interface, author technical documents, and travel 20% to CDMO sites

Qualifications

• Ph.D. in Organic Chemistry or related discipline with 12+ years in chemical development of small-molecule pharmaceuticals.
• Demonstrated success leading pharmaceutical CMC drug substance development in outsourced environments.
• Strong vendor/CDMO management and cross-functional collaboration skills.
• Expertise in authoring development reports and regulatory submissions.

Responsibilities

• Lead cross-functional teams engaged in external cGMP manufacturing of drug substance and starting materials.
• Collaborate with medicinal chemistry to support candidate selection and developability assessments.
• Provide technical and functional project leadership on drug substance process development and CDMO partner management.
• Oversee tech transfer and ensure supply continuity.
• Author and review technical documents for IND/IMPD and global filings.
• Stay current with global regulations and industry standards.
• Represent Drug Substance Development in regulatory interactions and with FDA/EMA.
• May supervise one or more process chemists.

Skills

Leadership

CDMO management

Regulatory writing

Cross-functional collaboration

Project leadership

Vendor management

Education

Ph.D. in Organic Chemistry (12+ yrs)

M.S. in Chemistry (15+ yrs)

Tools

JMP

MS Word

Excel

PowerPoint

MS Project

Job description

The Director, Chemical Development will have overall responsibility for leading and managing development and manufacturing activities for drug substance, DS intermediates, and starting materials for one or more Treeline programs. The scope of the role encompasses process development, scale-up, and characterization/design space mapping of the manufacturing process of a drug candidate, up to and including process performance qualification (PPQ). Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for CDMO selection and the development of strong and enduring business partnerships supporting assigned programs. The successful candidate will also assume a key leadership role in the development, review, and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs.

The successful candidate will be an experienced process chemist with significant experience in Chemical Development and strong familiarity with the other CMC disciplines and in navigating interdisciplinary connections associated with successful CMC development. S/he will possess strong leadership, management and communication skills, ensuring that internal and external business partners understand and respect program goals, objectives, priorities, and timelines.

Responsibilities

• Lead and manage cross-functional teams engaged in external cGMP manufacturing of drug substance, DS intermediates, and starting materials.
• Collaborate with medicinal chemistry partners to support candidate selection and developability assessments. Advise and assist with sourcing scaffolds and intermediates as appropriate.
• Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management.
• Oversee technical transfer activities between CDMOs as needed to ensure supply continuity.
• Collaborate with Analytical Development to ensure the development and validation of analytical test methods for drug substances.
• Ensure timely documentation review and approval to ensure supply continuity (Batch records, specifications, change controls, etc.).
• Provide technical input to deviation investigations to assess impact to product and manufacturing processes.
• Partner with Quality Assurance and CMC Regulatory to develop and implement appropriate processes and controls to ensure drug substance batches meet specifications and adhere to cGMP when required.
• Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events.
• Work closely with Analytical Development/QC, Quality Assurance, Regulatory CMC, Supply Chain, and external manufacturing operations to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones.
• Author and review technical documents, process development reports, and drug substance sections for IND, IMPD, and global marketing applications.
• Stay current with applicable global regulations and industry standards.
• Represent Drug Substance and Chemical Development in meetings with FDA, EMA, and related regulatory authorities.
• May supervise one or more process chemists.

Qualifications

• Ph.D. in Organic Chemistry, or related discipline with a minimum of 12+ years of experience, or Master with a minimum of 15+ years of experience in the Chemical Development of small-molecule pharmaceuticals.
• Demonstrated successful leadership in a pharmaceutical CMC drug substance development role.
• Track record of success in leading and managing small-molecule drug substance programs in a 100% outsourced environment.
• Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
• Broad experience working with and managing external CDMO partners, including use of performance and quality 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, but not limited to, development reports, master batch records, analytical testing methods, and specifications.
• Deep understanding of global regulatory requirements for the manufacture, testing, and control of drug substances.
• Demonstrated success with authoring drug substance sections of INDs, IMPDs, and marketing applications, and practice responding to inquiries from regulatory agency reviews.
• Strong project leadership skills with the ability to manage complex timelines, multiple stakeholders, and evolving program priorities.
• Exceptional communication and collaboration skills with a proven ability to work cross-functionally in a fast-paced, science-driven environment.
• Understanding of basic budgeting processes.
• Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
• Ability to travel (20%) to CDMO domestic and international sites.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools).
• High level of personal integrity, commitment to excellence and to our patients.
• Experience in developing and commercializing drugs for oncology is preferred.