Senior Manager, Analytical Chemistry

This is a fully remote position, open to applicants in United States.

📋 Description

• Design and implement phase-appropriate analytical and control strategies for assigned drug substance and drug product programs.

• Independently oversee analytical programs, vendor partnerships, and technical deliverables.

• Identify, qualify, and manage CROs, CDMOs, CMOs, and contract laboratories.

• Supervise 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 documentation.

• Create, assess, and justify specifications and acceptance criteria for drug substance and drug product.

• Assist in impurity and degradant identification, characterization, qualification, and control.

• Design and oversee non-GMP, GLP, and cGMP stability programs while providing expiry-dating recommendations.

• Offer analytical oversight for routine testing, manufacturing, batch disposition, clinical supply, material release, retest dates, and expiry dating.

• Lead or critically evaluate 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.

• Write and review analytical CMC content and source documents for regulatory submissions and health authority responses.

• Represent analytical CMC in program and project-team meetings while collaborating with cross-functional teams.

• Develop and enhance analytical workflows, procedures, trackers, templates, and governance practices.

• Communicate complex technical information, mentor partner scientists, and advocate for scientific rigor and continuous improvement.

• Coordinate analytical samples, reference standards, and related documentation.

⛳️ Requirements

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related field 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 taken into account.

• Significant experience supporting analytical development and quality control of small-molecule drug substances and drug products across various development stages.

• Experience, preferably, includes solid oral dosage forms.

• Proven ability to manage analytical activities conducted by CROs, CDMOs, CMOs, and contract laboratories.

• Strong working knowledge of HPLC/UHPLC, dissolution, GC, spectroscopy, moisture analysis, and mass spectrometry.

• Robust knowledge of analytical method development, qualification, validation, transfer, and lifecycle management.

• Ability to interpret relevant ICH, FDA, and global regulatory expectations.

• Familiarity with 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 writing or contributing to analytical CMC sections, technical reports, control strategies, specification justifications, and regulatory submissions.

• Demonstrated project management skills, sound judgment, and the ability to manage multiple priorities independently.

• Excellent written and verbal communication skills, keen attention to detail, and the ability to collaborate and influence without formal authority.

• Preferred: experience in late-stage analytical development, registration, process validation, commercialization readiness, or post-approval analytical lifecycle management.

• Preferred: global regulatory submissions and responses to health authority inquiries or inspection observations.

• Preferred: experience in impurity profiling, forced degradation, LC-MS/HRMS, NMR, spectroscopy, structural elucidation, or complex-matrix characterization.

• Preferred: familiarity with 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 settings.

• Occasional evening, weekend, holiday, and on-call work may be necessary.

• Background screening is required as a condition of employment.

🏝️ Benefits

• Benefits are included.

• Bonus may be provided.

• Equity may be provided.

• Remote work arrangement available.

• 40-hour work week.

• Equal opportunity employer.