The Director/SD, 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 CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with late-phase development and product registration. 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.
- Provide technical and functional project leadership on drug substance process development, manufacturing, and CDMO partner management.
- Lead and manage process transfers and associated site implementation to support supply chain expansion activities and continuous improvement initiatives.
- Monitor, track and trend process performance. Develop and implement data analytics to support investigations and provide an historical baseline for future operational and process-related improvements.
- 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.
- Lead the selection of drug substance CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish KPIs to monitor site technical, quality and business performance.
- Develop and maintain strong relationships with CDMO business partners and participate in Steering Committees as appropriate.
- Review/approve technical reports, controlled GMP documents and CMC content for Module 3 CTDs.
- Develop and manage scope, milestones, interdependencies, budgets and timelines associated with drug substance program deliverables. Ensure cross-functional alignment of drug substance program deliverables with overall program strategy.
- Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address Drug Substance and supply chain risk.
- Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.
Qualifications - Ph.D. in Organic Chemistry, Chemical Engineering, or related discipline with a minimum of 12+ years of experience, or Master's with a minimum of 15+ years of experience in small molecule drug substance development.
- 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.
- Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
- Expertise in authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications.
- Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration. Extensive experience in working with regulatory authorities. Track record of authoring and defending Module 3 CTD content through regulatory approval and commercialization.
- Ability to articulate complex issues and ideas with clarity to enable understanding and decision making.
- Pragmatic, solution-oriented thinker who possesses a "can do" and "whatever it takes" attitude, coupled with excellent organizational and communication skills.
- Strong interpersonal and decision-making skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
- 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 $229,978 to $277,846. 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.
