Remote Associate Director of Analytical Sciences | WFH

Job Overview

We are in search of an accomplished and driven Associate Director of Analytical Sciences to become an integral member of our dynamic team. In this pivotal role within our analytical research and development division, you will significantly contribute to the progression of innovative therapeutics aimed at combating cancer resistance. This position provides flexibility with options for onsite, hybrid, or remote engagement, ideal for those who are committed to making a substantial impact and excel in a collaborative atmosphere.

Key Responsibilities
• Lead and oversee both outsourced and in-house analytical research activities, ensuring efficient execution of projects.
• Act as a subject matter expert on tech transfer and process development, collaborating with external vendors and contract manufacturing organizations (CMOs).
• Formulate and implement strategies for external projects, providing technical expertise and strategic direction to guarantee the prompt and accurate fulfillment of product requirements through all drug development stages, from discovery to clinical and commercial phases.
• Direct analytical method development, solid-state characterization, validation, release, and stability testing, managing efforts internally and with CDMOs.
• Partner with external collaborators on GMP manufacturing and product characterization, including preparation and review of analytical methods, validation protocols, stability reports, and certificates of analysis (CoAs).
• Support investigations and quality events at CDMOs/CROs, in close partnership with the quality assurance team.
• Author and review technical documentation and regulatory submissions including INDs, NDAs, and annual reports.
• Deliver presentations to internal and external stakeholders, effectively articulating research findings and progression.
• Collaborate cross-functionally with teams in Regulatory, Quality, Pre-clinical, and Process/Formulation Development for successful project execution.
• Maintain comprehensive oversight of batch genealogy, stability, and test outcomes, ensuring data is systematically archived and translated into actionable insights.
• Facilitate selection and enablement of CMOs in collaboration with formulation and process teams, ensuring seamless operations and uninterrupted supply.
• Manage project deliverables and budgets, oversee progress documentation, and coordinate contracts and invoicing with finance.

Required Skills
• Ph.D. in analytical chemistry or a related discipline, coupled with a minimum of 10 years of practical experience in the pharmaceutical or biotech sectors, focusing on new drug discovery and development.
• Strong problem-solving skills, scientific curiosity, and critical thinking capabilities.
• Proven leadership skills, with a history of initiating projects and addressing complex challenges strategically.
• Extensive familiarity with analytical techniques such as UHPLC, GC, LC-MS, GC-MS, SFC, dissolution, DSC, TGA, PSD, XRPD, and spectroscopic methodologies.
• Awareness of cross-functional activities within toxicology and clinical development.
• Proficiency in working autonomously and effectively within a fast-paced, collaborative team environment, both internally and with external partners (e.g., CROs, CMOs, CDMOs).
• Experience in authoring and evaluating product specifications, method validation protocols, analytical methodologies, and stability reports.
• Preferred background in late-stage pharmaceutical drug development, including dissolution method development and control strategy formulation.
• A solid understanding of process chemistry in drug development, including specification establishment and justification, is advantageous.
• In-depth knowledge of ICH and regulatory standards, with meticulous attention to detail and prior experience in GLP and cGMP settings.
• Demonstrated scientific excellence through publications, presentations, or recognized leadership within the scientific community.

Career Growth Opportunities

This role offers substantial opportunities for professional advancement, allowing you to lead initiatives and strategically contribute to project success. Collaborating with a team of experts and external partners will further enrich your skills and career trajectory within the industry.

Employment Type: Full-Time

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