Senior Manager, Analytical Chemistry
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Job Description
Senior Manager overseeing outsourced analytical CMC for Enliven’s small-molecule therapeutics. Leading method development, stability, quality investigations, vendors, and regulatory documentation.
Responsibilities:
- Develop and execute phase-appropriate analytical and control strategies for assigned drug substance and drug product programs
- Independently lead analytical programs, vendor relationships, and technical deliverables
- Select, qualify, and manage CROs, CDMOs, CMOs, and contract laboratories
- Oversee analytical method development, optimization, qualification, validation, verification, transfer, and lifecycle management
- Review analytical methods, protocols, raw data summaries, validation and transfer packages, certificates of analysis, stability reports, and technical documents
- Develop, evaluate, and justify specifications and acceptance criteria for drug substance and drug product
- Support impurity and degradant identification, characterization, qualification, and control
- Design and manage non-GMP, GLP, and cGMP stability programs and provide expiry-dating recommendations
- Provide analytical oversight for routine testing, manufacturing, batch disposition, clinical supply, material release, retest dates, and expiry dating
- Lead or critically review deviations, laboratory investigations, atypical results, OOS/OOT events, root-cause assessments, impact assessments, and CAPAs
- Provide risk-based guidance for method failures, unexpected results, sample preparation issues, instrument events, and complex analytical challenges
- Author and review analytical CMC content and source documents for regulatory submissions and health-authority responses
- Represent analytical CMC in program and project-team meetings and collaborate with cross-functional functions
- Develop and improve analytical workflows, procedures, trackers, templates, and governance practices
- Communicate complex technical information, mentor partner scientists, and promote scientific rigor and continuous improvement
- Coordinate analytical samples, reference standards, and associated documentation
Requirements:
- Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or 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
- Substantial experience supporting analytical development and quality control of small-molecule drug substance and drug product across multiple development stages
- Experience preferably including solid oral dosage forms
- Demonstrated ability to manage analytical activities performed by CROs, CDMOs, CMOs, and contract laboratories
- Strong working knowledge of HPLC/UHPLC, dissolution, GC, spectroscopy, moisture analysis, and mass spectrometry
- Strong knowledge of analytical method development, qualification, validation, transfer, and lifecycle management
- Ability to interpret applicable ICH, FDA, and global regulatory expectations
- Working knowledge of GLP, cGMP, laboratory controls, data integrity principles, and current analytical development and quality-control practices
- Experience investigating or reviewing deviations, atypical data, OOS/OOT results, method failures, and stability issues
- Experience authoring or contributing to analytical CMC sections, technical reports, control strategies, specification justifications, and regulatory submissions
- Proven project management skills, sound judgment, and ability to manage multiple priorities independently
- Excellent written and verbal communication skills, strong attention to detail, and ability to collaborate and influence without formal authority
- Preferred: late-stage analytical development, registration, process validation, commercialization readiness, or post-approval analytical lifecycle management
- Preferred: global regulatory submissions and responses to health-authority questions or inspection observations
- Preferred: impurity profiling, forced degradation, LC-MS/HRMS, NMR, spectroscopy, structural elucidation, or complex-matrix characterization
- Preferred: QC laboratory operations, laboratory quality systems, inspection readiness, or technical team leadership
- Preferred: risk-based approaches in lean, virtual, or highly outsourced clinical-stage biotechnology environments
- Occasional evening, weekend, holiday, and on-call work may be required
- Background screen required as a condition of employment
Benefits:
- Benefits are included
- Bonus may be provided
- Equity may be provided
- Remote work arrangement
- 40-hour work week
- Equal opportunity employer
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