Senior Manager, Analytical Chemistry in Abbeyville, Colorado at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Analytical Chemistry based in United States.

The Senior Manager, Analytical Chemistry will play a key role within a lean, highly collaborative CMC organization supporting small-molecule drug substance and drug product programs.
This position offers substantial ownership of analytical CMC workstreams from preclinical development through registration.
You will translate program strategy into executable analytical plans while providing technical oversight across outsourced development and testing activities.
The role combines scientific leadership, external partner management, data and document review, investigations, regulatory support, and operational execution.
You will collaborate closely with Process Chemistry, Quality, Regulatory, Clinical Supply, and Project Management teams to advance critical development milestones.
Success requires strong scientific judgment, attention to detail, and the ability to influence decisions in a fast-paced, highly outsourced environment.
This is an opportunity to make a meaningful impact on analytical strategy, product quality, regulatory readiness, and the advancement of innovative therapies.

• Develop and execute phase-appropriate analytical development and control strategies for assigned small-molecule drug substance and drug product programs.
• Independently own designated analytical workstreams, technical deliverables, vendor relationships, timelines, and project priorities while escalating significant risks and resource needs appropriately.
• Select, qualify, and manage CROs, CDMOs, CMOs, and contract testing laboratories, including scopes of work, budgets, timelines, responsibilities, meeting cadence, and deliverables.
• Oversee the development, optimization, qualification, validation, verification, transfer, and lifecycle management of analytical methods.
• Provide analytical oversight across drug substance, drug product, starting materials, intermediates, in-process samples, release testing, and stability programs.
• Critically review analytical methods, protocols, raw-data summaries, validation and transfer packages, certificates of analysis, stability reports, and other technical documentation for scientific accuracy, completeness, data integrity, and regulatory suitability.
• Develop, evaluate, and justify phase-appropriate specifications and acceptance criteria for release, stability, in-process, and raw-material controls.
• Support impurity and degradant identification, characterization, qualification, and control, including forced degradation studies and reference-standard qualification.
• Design and manage non-GMP, GLP, and cGMP stability programs, review trends and excursions, and provide recommendations related to retest periods, shelf life, use periods, and expiry dating.
• Provide analytical support for manufacturing, clinical supply, material release, batch disposition, retest dates, expiry dating, and other product-quality decisions.
• Lead or critically review deviations, laboratory investigations, atypical results, OOS/OOT events, root-cause assessments, impact assessments, and CAPAs in partnership with Quality and external vendors.
• Provide practical, risk-based solutions to method failures, unexpected analytical results, sample preparation challenges, instrument issues, and other complex technical problems.
• Author and review analytical CMC content and source documents for INDs, IMPDs, NDAs, amendments, briefing packages, and responses to health-authority questions.
• Represent Analytical CMC in cross-functional program and project meetings and collaborate with Process Chemistry, Quality, Regulatory, Clinical Supply, Project Management, and other stakeholders.
• Improve analytical workflows, procedures, trackers, templates, and governance practices to increase efficiency, compliance, transparency, and timely decision-making.
• Communicate complex scientific and technical information clearly to internal and external stakeholders and provide technical guidance and mentorship to partner scientists.
• Coordinate analytical samples, reference standards, and associated documentation as required by development programs.
• Contribute to a culture of scientific rigor, accountability, operational excellence, and continuous improvement within a lean CMC organization.

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related discipline with 6+ years of relevant pharmaceutical or biotechnology experience; alternatively, an M.S. with 9+ years or a B.S. with 12+ years of relevant experience. Equivalent combinations of education and directly relevant experience may be considered.
• Substantial experience supporting analytical development and quality control for small-molecule drug substance and drug product across multiple stages of pharmaceutical development.
• Experience with small-molecule products, preferably including solid oral dosage forms.
• Demonstrated experience managing analytical activities performed by CROs, CDMOs, CMOs, and contract laboratories within an outsourced operating model.
• Strong knowledge of analytical techniques including HPLC/UHPLC, dissolution, GC, spectroscopy, moisture analysis, and mass spectrometry, with the ability to critically assess analytical data and method performance.
• Strong understanding of analytical method development, qualification, validation, transfer, and lifecycle management.
• Working knowledge of applicable ICH, FDA, and global regulatory expectations for analytical development and quality control.
• Practical knowledge of GLP and cGMP requirements, laboratory controls, data integrity principles, and current industry practices.
• Experience investigating or reviewing deviations, atypical data, OOS/OOT results, method failures, and stability issues and developing scientifically justified conclusions and corrective actions.
• Experience authoring or contributing to analytical CMC sections, technical reports, control strategies, specification justifications, and regulatory submissions.
• Proven project management skills, sound scientific judgment, and the ability to manage multiple priorities while independently advancing deliverables.
• Excellent written and verbal communication skills, strong attention to detail, and the ability to collaborate effectively across technical and functional teams.
• Ability to lead through influence, make risk-based decisions, and operate effectively without relying on formal authority.
• Experience working in dynamic, fast-paced pharmaceutical or biotechnology environments.

Preferred experience:

• Experience with 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 in lean, virtual, highly outsourced, or clinical-stage biotechnology environments.

• Full-time, remote position based in the United States.
• 40-hour work week with flexibility appropriate to program and business needs.
• Annual salary range of $115,000–$135,000, with actual compensation determined by experience, qualifications, skills, expertise, geographic location, and other job-related factors.
• Benefits included as part of the overall compensation package.
• Potential eligibility for additional incentives, including bonus and equity.
• Opportunity to work on innovative small-molecule therapeutic programs within a clinical-stage biotechnology environment.
• Significant ownership of analytical CMC workstreams and exposure to development activities spanning preclinical stages through registration.
• Collaboration with multidisciplinary teams across CMC, Quality, Regulatory, Clinical Supply, Process Chemistry, and Project Management.
• Opportunity to lead external scientific partners and influence analytical strategy in a highly outsourced operating model.
• Professional growth through technical leadership, regulatory involvement, cross-functional collaboration, and complex analytical problem-solving.
• Occasional evening, weekend, holiday, or on-call work may be required based on program and business needs.