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Retro

CMC and Clinical Supply Specialist

On site Operations
Added
4 days ago
Location
Type
Full time
Salary
$110K - $140K

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Related skills

cmc gmp drug substance drug product clinical supply planning

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, Chemistry, Manufacturing, and Controls (CMC), supply chain, and clinical operations 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 are excited to take on tough challenges and contribute to advancing therapies that extend healthy human lifespan!

In this role you will:

  • Forecast drug supply needs, managing inventory, and coordinating shipments to clinical sites.
  • Contribute to the development and implementation of CMC strategies, ensure compliance with regulatory requirements, and manage drug product manufacturing logistics.
  • Manage drug substance and internal chemical library.
  • Working closely with internal teams such as clinical operations, regulatory, CMC, and others to align on timelines and ensure seamless supply chain operations.
  • Collaborate with CDMOs, CROs, and clinical sites, managing day-to-day execution and vendor relationships.
  • Develop and manage budgets for clinical supply activities.
  • Ensure that all clinical supply activities adhere to quality standards and regulatory requirements.

    • You might thrive in this role if you have:

  • A bachelor’s degree in chemistry / Biochemistry or related field with >3 years in biotech/pharma.
  • An understanding of drug substance and drug product development (small molecules).
  • Familiarity with GMP requirements for clinical and commercial production.
  • Knowledge of analytical method development, stability studies, specification setting.
  • Basic understanding of regulatory documentation (Module 3 of the CTD, IND/IMPD content).
  • Experience with clinical trial supply planning, including labeling and packaging, import/export coordination, and depot and site distribution.
  • Experience working with CDMOs, CROs, and clinical sites.
  • Experience in forecasting and inventory management.
  • Excellent communication, interpersonal, and problem-solving skills.

    • It’s a bonus if you have:

  • Experience with IND/IMPD/CTN submissions.
  • Exposure to autophagy-related programs or aging biology.
  • Experience in early-phase trial logistics (e.g., CTN in Australia, global depot management).
  • Familiarity with eTMF or QMS systems.

    • Additional Information

    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.

    Compensation

    At Retro, we don’t use titles. New hires join as a “Member of X Team.” Depending on experience, this role could flex from a Specialist/Senior Specialist level to an Associate Manager/Manager level.

    Total compensation includes competitive base salary, generous equity, and benefits including:

    - Medical, dental, and vision insurance for you and your family

    - 401(k) plan with 4% matching

    - Flexible time off and 10 company holidays per year

    - Paid parental leave

    - Annual learning & development stipend

    - Daily Retro-sponsored lunch and snacks

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