Senior Manager, Analytical Development – Small Molecules

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

📋 Description

• Formulate strategies and deliver technical guidance while supervising analytical operations at external laboratories.

• Manage the development, validation, qualification, stability testing, and investigational testing of methods.

• Offer regulatory support throughout the phases of drug development, from initial stages to commercial realization.

• Create analytical tools to assess crucial quality attributes in products and processes involving synthetic small molecules, synthetic peptides, and various modalities.

• Collaborate with departments such as analytical, drug substance and product process development, regulatory affairs, and quality assurance.

• Spearhead the development, optimization, and transfer of methods for testing and characterizing synthetic small molecules at contract manufacturing organizations (CMOs) or testing labs.

• Deliver actionable insights and recommendations derived from the analysis of analytical projects, encompassing logistics, budgeting, method development, release testing, and reporting.

• Track progress, recognize risks, execute mitigation strategies, and ensure alignment with strategic goals.

• Direct the formulation and execution of scientific strategies that comply with regulatory standards and adhere to industry best practices.

• Supply analytical data that supports the development of drug substances and drug products, including purity analysis, chiral purity, and structural elucidation utilizing mass spectrometry.

• Oversee pharmaceutical stability studies, protocols, and timelines related to IND and NDA activities.

• Draft technical reports and CMC sections for regulatory submissions.

• Guide and train team members.

⛳️ Requirements

• A bachelor's or master's degree in analytical science, chemistry, or a related field along with 10 years of relevant experience, or a Ph.D. in the same fields with 5 years of experience.

• A minimum of 10 years of experience with a bachelor's or master's degree, or 5 years with a Ph.D.

• Experience in a GxP setting with a focus on analytical laboratory testing of pharmaceuticals and similar materials.

• Exceptional leadership, communication, and interpersonal abilities.

• Familiarity with the drug development lifecycle, including preclinical and clinical phases, regulatory mandates, and quality benchmarks.

• Proficient in MS Office applications, particularly MS Excel.

• Background in data analysis.

• Strong oral and written communication abilities.

• Capability to prioritize and manage several projects simultaneously, adhering to deadlines, and adjusting to shifting priorities.

• Proficient project management capabilities.

• Sound judgment, decision-making, negotiation, and organizational skills.

• Experience in the pharmaceutical or biotech sector, particularly in process and product development and analytical method creation for drug substances and products.

• Comprehensive understanding of small molecule analysis and structure elucidation informed by organic chemistry.

• Practical experience in method development, characterization, and analytical control strategies, especially with mass spectrometry.

• Expertise in structure elucidation and physicochemical techniques including MS, UV, NMR, and FTIR.

• Familiarity with USP monographs and chapters, as well as ICH/FDA guidance documents.

• Ability to collaborate effectively within cross-functional teams across various geographic locations and time zones.

• Excellent technical writing proficiency.

• A bachelor’s or master’s degree with 10 years of experience, or a Ph.D. with 5 years of experience in a GxP environment.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death & dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement options.

• Assistance with student loans.

• Generous 401(k) matching program.

• Flexible time off policy.

• Paid holiday leave.

• Paid leave programs available.

• Opportunities for incentives.