CMC Manager

AI overview

Coordinate and optimize the operational infrastructure to advance autophagy-enhancing compounds into clinical trials, bridging drug development and CMC processes.
Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan. We’re building a mission-driven team of accomplished and kind individuals who embrace our startup culture of rapid iteration, transparency, and versatility.  Our autophagy program is advancing rapidly and leading the charge in translating our science into a first-in-human clinical trial, marking a major step toward delivering transformative therapies rooted in the biology of aging. We’re hiring a new team member to coordinate and optimize the operational infrastructure needed to advance our autophagy-enhancing compounds into the clinic. In this highly cross-functional role, you’ll bridge drug development and Chemistry, Manufacturing, and Controls (CMC) to ensure a seamless transition from discovery to first-in-human studies. You’ll focus on drug substance and product readiness, planning and managing clinical trial material (CTM) supply, and aligning cross-functional timelines to drive development forward. This role reports to the Head of Early Drug Development. About you: You share our sense of urgency and excitement, and thrive in fast-paced, interdisciplinary environments. You work well independently but will also enjoy being part of a highly-collaborative, multi-disciplinary team. You understand how to work on a lean team, both leading strategic aspects of a process while also doing the hands-on work. You are excited to take on tough challenges and contribute to advancing therapies that extend healthy human lifespan! In this role you will:
  • Managing CROs, CDMOs, and managing day-to-day execution and vendor relationships.
  • Lead route scouting, process chemistry, analytical activities, and manufacturing of small-molecule investigational products.
  • Contribute to the development and implementation of CMC strategies, and ensure compliance with regulatory requirements.
  • Manage drug substances and internal chemical libraries with proper documentation and traceability.
  • Working closely with internal teams such as clinical operations, regulatory, Sciops, and others to align on timelines and ensure seamless supply chain operations.
  • Forecast drug supply needs, managing inventory, and supporting clinical supply activities, such as import and export, customs clearance, etc.
  • This role includes at least some hands-on work, and is not a 100% desk job.
  • You might thrive in this role if you have:
  • A bachelor’s degree with 10+ years of industry experience or PhD with 5+ years of industry experience in organic chemistry or related fields.
  • Experience managing external CROs for research and development of small molecule drug substance and drug product.
  • Basic understanding of regulatory documentation (Module 3 of the CTD, IND/IMPD content).
  • Experience in forecasting and inventory management.
  • Excellent communication, interpersonal, and problem-solving skills.
  • It’s a bonus if you have:
  • Experience with clinical trial supply planning, including labeling and packaging, import/export coordination, and depot and site distribution.
  • Knowledge in IND/IMPD/CTN submissions.
  • Exposure to autophagy-related programs or aging biology.
  • We take pride in cultivating an environment that fosters collaboration, open communication, and authenticity. We believe that great results are best delivered by a highly creative team working in concert. We are an equal opportunity employer; we do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are diverse in background and singular in mission.

    Perks & Benefits Extracted with AI

    • Flexible Work Hours: Flexible time off and 10 company holidays per year
    • Free Meals & Snacks: Daily Retro-sponsored lunch and snacks
    • Health Insurance: Medical, dental, and vision insurance for you and your family
    • Learning Budget: Annual learning & development stipend
    • Paid Parental Leave: Paid parental leave

    Retro Biosciences is dedicated to extending healthy human lifespan by focusing on cellular reprogramming, autophagy, and plasma-inspired therapeutics to develop innovative treatments that target the underlying mechanisms of aging and prevent age-relate...

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    Salary
    $145,000 – $190,000 per year
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