Associate Director, Analytical Chemistry

Job Type Full-time Description

 

BioAge Labs (BIOA) is a publicly held biopharmaceutical company that is harnessing the biology of human aging to develop new therapies for metabolic diseases. 

We are seeking a highly motivated professional to join our Chemistry, Manufacturing, and Controls (CMC) team.

The Role: In this position, you will leverage your analytical chemistry expertise to drive the development of robust analytical methodologies, oversee method development and validation, manage stability studies, and lead the characterization of drug substances and products. You will collaborate extensively with Contract Development and Manufacturing Organizations (CDMOs), ensuring our analytical strategies align with clinical development phases and regulatory requirements. This is a full-time, remote position. 

You: You have deep technical knowledge in analytical chemistry with a proven track record of supporting drug development programs. Your strategic mindset enables you to anticipate analytical challenges and develop comprehensive solutions. You thrive in collaborative environments, effectively partnering with internal teams and external organizations to advance high-quality drug candidates. You are passionate about developing innovative therapies that target age-related and metabolic diseases.

Essential job duties:

• Strategically Oversee Analytical Chemistry Initiatives: Lead analytical and bio-analytical chemistry strategies at CDMOs for active pharmaceutical ingredients (API) and drug product (DP), ensuring alignment with organizational objectives and innovation in analytical methodologies.
• Lead Quality Control Data Oversight: Spearhead coordination, analysis, and reporting of QC data from CDMOs, emphasizing data integrity and strategic decision-making.
• Ensure Regulatory Compliance of CDMO Practices: Conduct reviews to guarantee CDMO compliance with regulatory standards and act as a liaison with regulatory bodies.
• Direct API and DP Characterization Studies: Guide CDMOs in API and DP characterization and comparability studies, adopting innovative approaches to analytical challenges.
• Lead Technical Gap Analysis and Method Optimization: Identify technical gaps in analytical methods, ensuring readiness for regulatory approval and leading improvements.
• Orchestrate Technical Investigations and Problem Resolution: Resolve aberrant results, including out of trend (OOT) and out of specification (OOS) data, through detailed investigations and corrective actions.
• Manage Analytical Method Transfers: Oversee method transfers to secondary and central labs, ensuring integration and continuity of analytical capabilities.
• Compile and Analyze Stability Data: Aggregate stability data from CDMOs, generating reports that inform stability studies and shelf-life determinations.
• Develop Shelf-life Projections and Product Specifications: Establish shelf-life projections and product specifications for API and DP based on analytical data.
• Oversee Analytical Reference Standards Management: Lead management of analytical reference standards and plan for qualification work or synthesis based on inventory levels.
• Craft Control Strategies for API and DP: Develop control strategies for API and DP processes, enhancing product quality and consistency.
• Author and Review Regulatory Submission Documents: Lead the creation and review of CMC sections for global regulatory submissions, ensuring accuracy and persuasiveness of documentation.

Required skills and abilities:

• Ability to drive analytical method development for drug substance, impurity characterization and reference standard qualification and for small molecule drug products including oral and parenteral formulations
• Expert knowledge in a wide range of analytical techniques and methodologies, with the ability to innovate and improve analytical practices including the ability to identify degradation pathways and drive solutions for mitigation.
• Strong analytical and problem-solving skills, capable of addressing complex scientific questions and technical challenges.
• Excellent communication skills, with the ability to effectively convey technical concepts and strategies to a broad audience, including CDMOs and regulatory bodies.
• Demonstrated ability to work independently as a high-level individual contributor, while effectively collaborating with cross-functional teams.
• Excellent verbal and written communication and skills coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision.
• Familiar with a wide range of analytical techniques like HPLC, LCMS, NMR, FTIR, KF, TGA, DSC, GC, GCMS, etc.
• MS Excel, Powerpoint
• Familiarity with drawing structures in software su