Director, Chemical Development

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.

• 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.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown is $222,329 to $243,300. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.