CMC and Clinical Supply Specialist

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.

$110,000 – $140,000 a year

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