Associate Director, Analytical Development (CMC)

About Treeline:

Treeline Biosciences is an innovative biotechnology company, founded by an experienced team of biopharmaceutical scientists and executives, committed to developing new medicines against difficult to drug targets in cancer and other life-threatening diseases. We are pursuing a uniquely integrated approach that applies modern and emerging tools in genomics, lead discovery, medicinal chemistry, and computation to reduce the time and risks of drug discovery.

Job Summary:

The Associate Director of Analytical Development will lead CMC analytical development in the design, implementation, qualification, and validation of analytical methods and processes for the development of drug substance (DS) and drug product (DP). This role also involves overseeing the analytical characterization and stability of drug substances and drug products, ensuring compliance with regulatory standards, and driving innovation to enhance analytical capabilities.

Key Responsibilities:

• Responsible for all project management aspects of CMC Analytical R&D and Stability for drug substance and drug product.
• Will serve as the subject matter expert and lead the analytical research and development/stability study/QC functions with external CRO/CDMOs
• Will serve as the subject matter expert for analytical research and development/stability study/QC functions with external CRO/CDMOs, overseeing the development, optimization, qualification, and validation of analytical methods for small molecule and biologics drug substances/drug products.
• Provide hands-on analytical support for active pharmaceutical ingredient (API) process R&D and manufacturing, formulation development and drug product manufacturing.
• Foster a culture of collaboration with cross functional teams including process chemists, formulation scientists, quality assurance, regulatory affairs, and other departments to ensure alignment on CMC strategies and ensure timely project execution.
• Develop and execute analytical development strategies to support preclinical and clinical studies, ensuring compliance with regulatory requirements and industry standards.
• Provide strategic support and technical documentation for answering regulatory questions during submission reviews and throughout clinical development
• Ensure all analytical activities comply with FDA, EMA, and other regulatory requirements.
• Author and review CMC sections for all regulatory submissions (INDs, CTAs, IMPDs, NDAs, etc.) ensuring data integrity, scientific rigor, and ensuring analytical data meets regulatory expectations.
• Stay current with industry trends, emerging technologies, and regulatory changes related to analytical development
• Drive innovation in analytical techniques and technologies to improve efficiency and effectiveness.
• Identify and implement best practices and state-of-the-art methodologies in analytical development.
• Strong partnership with analytical colleagues in research.

Qualifications:

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field; Master’s and Bachelor’s degree with significant relevant experience may be considered.
• Minimum of 8 years of experience in analytical development within the pharmaceutical industry.
• Experience in CMC analytical development for small molecule programs required.  Familiarity with method development for Biologics and ADCs is considered a plus. 
• Experience writing regulatory documents, including CMC sections if INDs, technical protocols, reports, and procedures. 
• Proven track record of successfully leading analytical projects from early development through regulatory submission.
• Experience managing outsourced projects with contractors.
• Strong knowledge of analytical techniques and methodologies applicable to pharmaceutical development.
• Extensive knowledge of CMC processes, regulatory requirements, analytical method development/validation, and stability.
• Familiarity with global regulatory requirements, ICH guidelines, GMPs, and quality systems in the pharmaceutical industry.
• Strong problem-solving skills and the ability to work collaboratively in a fast-paced environment.
• Excellent communication and presentation skills, with the ability to convey complex scientific information to diverse audiences.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work in a fast-paced environment and manage multiple projects simultaneously.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in San Diego is $155,000 to $200,000. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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