Senior Manager, Analytical Chemistry

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.
• 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 observations.
• Expertise in impurity profiling, forced degradation, LC-MS/HRMS, NMR, spectroscopy, structural, elucidation, or characterization of complex matrices.
• Prior responsibility for QC laboratory operations, laboratory quality systems , inspection readiness, or technical team leadership.
• Experience applying risk-based approaches while operating in a lean, virtual, or highly outsourced clinical-stage biotechnology environment.
• This is a full-time remote position (40 hours/week). Occasional evening, weekend, holiday, and on-call work may be required as job duties demand.
• The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $115k - $135k. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying.
• Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
• Notice to agencies: Our in-house Talent Acquisition Team manages all employment opportunities at Enliven. Agencies and independent recruiters must be approved as a vendor by our HR team. To protect the interests of all parties, Enliven will not accept unsolicited resumes, profiles, or biographies. Any unsolicited submissions will be considered referrals and become the property of Enliven. Contacting hiring managers, executives, or any member of the HR team will not influence vendor approval and is strongly discouraged. Repeated outreach may impact future consideration.