Senior Manager, Analytical Chemistry

Description

Position: Senior Manager, Analytical Chemistry

Department: CMC

Location: Remote USA

Status: Full-time Exempt

About Us

Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies.

Role Summary

The Senior Manager, Analytical Chemistry will be a key member of Enliven Therapeuticss lean CMC organization and will independently drive assigned analytical CMC workstreams for small-molecule drug substance and drug product. Working closely with the Senior Director and Associate Director of CMC Analytical Chemistry, this individual will translate program strategy into executable plans and oversee outsourced analytical development and testing from preclinical development through registration. The role combines technical oversight, external partner management, data and document review, investigation leadership, regulatory writing, and operational follow-through. The successful candidate will lead through influence and take ownership of designated programs, vendors, and deliverables in a fast-paced, highly collaborative environment.

Responsibilities:

• •Analytical strategy and execution: Partner with CMC analytical leadership to develop and execute phase-appropriate analytical and control strategies for assigned drug substance and drug product programs
• •Workstream ownership: Independently lead designated analytical programs, vendor relationships, and technical deliverables while escalating key risks, decisions, and resource needs to CMC leadership.
• •External partner management: Select, qualify, and manage contract research, development, manufacturing, and testing organizations; align scopes of work, budgets, timelines, responsibilities, meeting cadence, and deliverables.
• •Analytical methods: Oversee development, optimization, qualification, validation, verification, transfer, and lifecycle management of analytical methods for drug substance, drug product, starting materials, intermediates, and in-process samples.
• •Technical and data review: Review analytical methods, protocols, raw data summaries, validation and transfer packages, certificates of analysis, stability reports, and other technical documents for scientific accuracy, completeness, data integrity, and regulatory suitability.
• •Specifications and control strategy: Develop, evaluate, and justify phase appropriate specifications and acceptance criteria for drug substance and drug product, including release, stability, in-process, and raw-material controls.
• •Impurities and reference standards: Support impurity and degradant identification, characterization, qualification, and control; oversee forced degradation studies, reference- standard qualification, and related material characterization activities.
• •Stability and expiry dating: Design and manage non-GMP, GLP, and cGMP stability programs; review trends and excursions; and provide recommendations for retest periods, shelf life, use periods, and expiry dating.
• •Routine testing and manufacturing support: Provide analytical oversight for starting material, in-process, release, microbial, and stability testing, and support manufacturing, batch disposition, clinical supply, material release, retest date, expiry dating, and disposition decisions.
• •Investigations and quality records: Lead or critically review deviations, laboratory investigations, atypical results, OOS/OOT events, root-cause assessments, impact assessments, and CAPAs in collaboration with Quality and external partners. Ensure records are scientifically sound, clear, timely, and inspection defendable.
• •Technical problem solving: Provide practical, risk-based guidance for method failures, unexpected results, sample preparation issues, instrument or laboratory events, and other complex analytical challenges.
• •Regulatory support: Author and review analytical CMC content and source documents for INDs, IMPDs, NDAs, amendments, briefing packages, and responses to health authority questions; ensure consistency across regulatory and technical documentation.
• •Cross-functional collaboration: Represent analytical CMC in program and project-team meetings and collaborate closely with Process Chemistry, Quality, Regulatory, Clinical Supply, Project Management, and other functions to meet program objectives.
• •Operational excellence: Develop and improve analytical workflows, procedures, trackers, templates, and governance practices that increase clarity, efficiency, compliance, and timely decision-making in an outsourced operating model.
• •Communication and technical leadership: Communicate complex technical information clearly to internal and external audiences, mentor partner scientists, and promote a culture of scientific rigor, accountability, and continuous improvement.
• •Additional responsibilities: Coordinate analytical samples, reference standards, and associated documentation as needed, and perform other duties consistent with the needs of a growing CMC organization.

Requirements

• •Education and experience: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline with 6+ years of relevant pharmaceutical or biotechnology experience; M.S. with 9+ years; or B.S. with 12+ years. Equivalent combinations of education and directly relevant experience will be considered.
• •Small-molecule development: Substantial experience supporting analytical development and quality control of small-molecule drug substance and drug product, preferably including solid oral dosage forms, across multiple stages of development.
• •Outsourced development model: Demonstrated ability to manage analytical activities performed by CROs, CDMOs, CMOs, and contract laboratories, including technical oversight, prioritization, timelines, and document quality.
• •Analytical expertise: Strong working knowledge of chromatographic and compendial techniques such as HPLC/UHPLC, dissolution, GC, spectroscopy, moisture analysis, and mass spectrometry, with the ability to critically evaluate analytical data and method performance.
• •Method lifecycle and regulations: Strong knowledge of analytical method development, qualification, validation, transfer, and lifecycle management and the ability to interpret applicable ICH, FDA, and global regulatory expectations.
• •GxP and data integrity: Working knowledge of GLP and cGMP requirements, laboratory controls, data integrity principles, and current industry practices for analytical development and quality control.
• •Quality-event expertise: Experience investigating or reviewing deviations, atypical data, OOS/OOT results, method failures, and stability issues and developing scientifically justified conclusions and effective corrective actions.
• •Regulatory documentation: Experience authoring or contributing to analytical CMC sections, technical reports, control strategies, specification justifications, and regulatory submissions.
• •Project leadership: Proven project management skills, sound judgment, and the ability to manage multiple priorities and independently advance deliverables in a dynamic environment.
• •Communication: Excellent written and verbal communication skills, strong attention to detail, and demonstrated ability to collaborate effectively and influence without relying on formal authority.

Preferred Experience:

• •Late-stage analytical development, registration, process validation, commercialization readiness, or post-approval analytical lifecycle management.
• •Experience supporting global regulatory submissions and responding to health-authority questions or inspection ob