Treeline Biosciences
Director/Sr Director, Chemical Development
Watertown, Massachusetts, United States · Director
Sponsorship not specified$230k-$278kDetected 64 days ago
Data AnalysisComplianceExcelSupply ChainHRGMPFDA RegulatoryLeadershipCommunicationCollaborationMicrosoft Office
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37Unrated
Cap-exempt (no lottery)0
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Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
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About the role
- 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.
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.
- Lead the selection of drug substance CDMOs based upon core capabilities, capacity and track record of regulatory compliance
- 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.
- 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.
Requirements
- 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.
- 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.
- 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.
- Ability to travel (20%) to CDMO domestic and international sites.
- 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.
- Pragmatic, solution-oriented thinker who possesses a "can do" and "whatever it takes" attitude, coupled with excellent organizational and communication skills.
- Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
- 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
Compensation
- The anticipated annual base salary range for candidates who will work in Watertown is $229,978 to $277,846.
Company info
- Keep the following in mind to protect yourself: - Treeline Biosciences will never ask for money from you as part of our recruitment process.
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This listing is sourced directly from Treeline Biosciences's careers page and normalized into a canonical job model.