Associate Director, Analytical Chemistry
BIOAGE LABS
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 such as ChemDraw
- Travel: The role may occasionally require travel or in-person engagements. Travel may vary up to 25% based on needs.
Education and Qualifications:
- Masters in Analytical Chemistry or equivalent scientific discipline with at least 10-15 years of industry experience in analytical chemistry for drug substance and drug product from early to late-stage clinical development and preparation for product registration required.
- PhD in Analytical Chemistry or a closely related scientific discipline, with at least 8-10 years of relevant industry experience in analytical chemistry, covering all stages of drug development and product registration preferred.
- Extensive experience in analytical method development, validation, and regulatory submission support, with a strong track record of innovation and technical excellence.
- Deep understanding of cGMPs, ICH guidelines, and FDA/EU regulations, with experience in interacting with regulatory agencies.
Our Company
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The company’s pipeline includes novel, orally available, brain-penetrant small-molecule NLRP3 inhibitors to treat metabolic diseases and conditions driven by neuroinflammation, as well as novel, structurally differentiated APJ agonists for metabolic disorders. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
Our Workplace
BioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits. We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development. This position is remote. The salary for this role is expected to be approximately $165,000 - $200,000 for someone who meets all of the minimum qualifications as listed for the role of Associate Director or Director, and may be adjusted accordingly for someone with more or less experience. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.
At BioAge, we embrace diversity and differences while we learn from each other, and we believe that every team member has an important role to play. We are an equal opportunity employer. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.
Physical Requirements:
Employees must meet certain physical requirements that are compliant with the Americans with Disabilities Act (ADA). It is our policy to provide reasonable accommodations when requested to enable individuals with disabilities to perform the essential functions of the job unless such accommodations would cause undue hardship.
- Visual Requirements: Ability to effectively utilize a computer and other communication tools to access, enter, and interpret data. Adequate vision required to perform job duties effectively (reasonable accommodations available).
- Communication Abilities: Must be capable of communicating effectively with teams and management via various electronic media and in-person when necessary. Ability to express and exchange ideas via spoken word and to perceive detailed information through oral communication.
- Manual Dexterity: Sufficient manual dexterity required for operating a computer and other office devices.
- Mental Acuity: Ability to concentrate on detailed information and tasks for extended periods. Capable of making sound decisions and solving problems based on data analysis.
- Sedentary Nature: This position is primarily sedentary, with occasional walking, standing, and/or stretching required for relief during extended hours at the workstation.
- Work Environment Adaptability: Ability to effectively manage a work environment that is free from significant distractions. Ability to set up and maintain an ergonomic and safe home office environment.
- Stress Management: Capability to manage work-related stress in a fast-paced environment, including handling urgent project deadlines and sensitive information.
- Emergency Response: Ability to respond promptly to emergencies as needed.