Manager/Sr. Manager of Analytical Chemistry

BioAge is a platform-driven, clinical-stage biotechnology company that is mapping human aging to develop a pipeline of therapies that treat disease and extend healthy lifespan. Our proprietary human-first platform encompasses >65M molecular measurements spanning 45+ years of human aging, and unlocks a universe of novel biological insights and druggable mechanisms for age-related disease. We currently have three clinical programs in our growing portfolio–two first in class and two first in indication–for immune aging and muscle aging. Ultimately, our mission is to develop therapies that change the nature of aging and provide patients with years more healthy time. To date, BioAge has raised $127M from Andreessen Horowitz, Kaiser Foundation Hospitals, and others.

For additional information about BioAge, visit the company’s website at www.bioagelabs.com.

Position Summary:The Manager/Senior Manager of Analytical Chemistry will play a key role in the CMC team through management of drug substance and drug product analytical testing, characterization, method development, validation and stability studies using an outsourced (CDMO) model.  This position brings the unique opportunity of solving challenges from early development through late-stage clinical development under the expanding pipeline at BioAge Labs.
Responsibilities

• Manage analytical chemistry efforts at CDMOs for API and DP and represent Bioage analytical chemistry on all CMC projects
• Coordinate, provide input and review QC data generated at CDMOs and report internally at project meetings
• Review and ensure CDMO methods, protocols and data collection procedures are in compliance with regulatory expectations 
• Guide and support CDMOs with API and DP characterization and comparability studies
• Identify technical gaps in existing work packages and ensure all methods are phase appropriate and ensure readiness for full approval over time
• Provide input for aberrant results, OOT and OOS data and lead technical investigations as needed
• Support analytical method transfers to secondary labs or central analytical labs as appropriate
• Collate incoming stability data from CDMOs and generate internal reports for stability studies (API and DP)
• Establish shelf-life projections for API and DP based on existing data
• Propose phase appropriate specifications for API and DP
• Manage inventory for analytical reference standards, impurity markers, radiolabeled compounds being stored at contract labs and plan/request for appropriate qualification work or synthesis (as applicable) based on depletion
• Provide input for establishing control strategies for API and DP processes
• Author appropriate CMC sections to support global regulatory (IND, IMPD, NDA, MAA) submissions

Qualifications

• Masters or PhD in Analytical Chemistry or equivalent scientific discipline
• At least 8 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
• Ability to identify degradation pathways and offer solutions for mitigation
• Must have analytical skills to support analytical method development for drug substance, impurity characterization and reference standard qualification as well as analytical methods for small molecule drug products including oral and parenteral formulations
• Must have experience with method comparability studies when dealing with changes
• Knowledge of cGMPs, ICH, and FDA regulations/guidance
• Experience authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, briefing books, NDA/MAA, etc.)
• Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects
• Ability to adapt to changing priorities and accelerated timelines that are typical of “small biotech”
• Ability to travel domestically and internationally up to 30% of the time. 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.

BioAge offers a comprehensive compensation package, as well as generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance), childcare and fertility benefits, along with a 401(k) retirement savings plan which includes matching employer contributions. We also pride ourselves in giving employees many opportunities for career development including a generous annual budget for continued learning, a direct and open-door environment, and a dedication to training and skill development.

At BioAge, everyone matters and we embrace diversity and differences while we learn from each other. 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.