Product Operation Associate

12 of the top 15 pharma generic companies in the world trust Leucine to manufacture the drugs that reach millions of patients every day.

Pharma manufacturing is one of the last large industries still running on paper, Excel, and tribal knowledge. A single missed step in a batch record can mean a recall, a regulatory warning, or a drug that should never have left the plant.

Leucine is the AI platform replacing all of it. Series A, backed by top-tier global investors, 60+ pharma enterprises in production, and the team that's going to define this category.

About the Role

We build software for pharmaceutical quality teams - the systems that decide whether a batch ships, whether an auditor walks away satisfied, and whether a deviation gets closed properly. That means every feature we release has to be correct, documented, and defensible to a regulator. Shipping fast and shipping validated are both non-negotiable, and that tension is exactly where this role lives.

You'll work alongside our Associate Product Manager as the operational backbone of the product function: testing what engineering builds, writing the test cases that define "done," producing the validation and CSV documentation our customers depend on, and keeping the paper trail clean while the product moves quickly.

This is not a role where you'll be told what to think about the roadmap on day one. It is a role where you'll see every feature up close, learn a regulated domain most PMs never touch, and build the judgment that makes a strong PM two years from now. If you want to learn product by being in the details of how it actually gets shipped, this is that seat.

What You'll Do

Test what we build

• Run structured functional test passes on new features before they reach customers - happy paths, edge cases, permissions, and the ugly states nobody designed for
• File bugs that engineers can act on immediately: clear repro steps, expected vs. actual, environment, severity
• Verify fixes and run regression sweeps ahead of each release so old bugs stay dead
• Coordinate and support UAT with internal stakeholders and, occasionally, customers

Write the test cases

• Translate PRDs and user stories into test cases with explicit preconditions, steps, and expected results
• Maintain and version the test case library as modules evolve - so the suite reflects the product as it is, not as it was two quarters ago
• Flag gaps in requirements early: if a spec can't be turned into a test case, it isn't finished, and you'll be the one to say so

Own the CSV and validation documentation

• Draft and maintain Computer System Validation deliverables - user and functional requirement specs, traceability matrices, IQ/OQ/PQ protocols, and test scripts
• Execute validation protocols and capture objective evidence (screenshots, logs, timestamps) to a standard that survives audit scrutiny
• Compile executed validation packages, log and route deviations, and keep documentation aligned with 21 CFR Part 11, GxP, and ALCOA+ expectations
• Work with engineering to keep validation artifacts in sync with what actually shipped

Write the documents that surround the product

• Release notes, user guides, in-app help content, and configuration guides
• Internal enablement material so sales, CS, and implementation teams can speak to new functionality accurately
• Meeting notes that become action items with owners, not notes that die in a doc

Support the APM on everything else

• Backlog hygiene - grooming tickets, chasing missing detail, keeping the board honest
• Competitor teardowns, feature research, and quick customer-facing artifacts
• Demo environment setup and test data preparation
• Pulling the data needed to answer "did this actually work?"

Requirements

What We're Looking For (Must-Haves)

• 0-2 years of experience - new graduates welcome. What matters is evidence you can be trusted with detail
• Exceptional written clarity. Most of your output is documents other people act on; ambiguity in your writing becomes rework for someone else
• Genuine rigor and patience for detail. In this domain, an untested edge case or an undocumented step is a real problem, not a nitpick
• Comfort using software deeply - you can learn a complex product quickly and reason about how it should behave, not just how it does
• High agency. You'll often be the person who notices the gap first, and we expect you to raise it rather than route around it
• Bachelor's degree in engineering, life sciences, pharmacy, computer science, or a related field (or equivalent practical experience)

Good to Have

• Exposure to pharma, biotech, medical devices, or any regulated environment - QA, QC, regulatory affairs, or validation experience is a strong plus
• Familiarity with GxP, 21 CFR Part 11, GAMP 5, or CSV/CSA concepts
• Hands-on QA or test-case-writing experience, manual or automated
• Comfort with tools like JIRA/Linear, Notion/Confluence, Figma, Postman, or Playwright
• Familiarity with AI-assisted tools (Claude, Cursor, and similar) to move faster on documentation and testing
• Basic SQL or spreadsheet fluency for answering simple product questions

Benefits

• Be part of a fast-growing SaaS company transforming the future of pharmaceutical manufacturing through cutting-edge technology
• Collaborate with a passionate, high-performing team building innovative AI-powered digital solutions
• Take ownership of impactful client implementations from day one, with ample opportunities for learning, career growth, and professional development
• Enjoy a competitive compensation package designed to reward your contributions
• Comprehensive Health Insurance with industry-leading coverage for your peace of mind
• Complimentary Meals & Refreshments: Stay energized with unlimited breakfast, lunch, snacks, and dinner provided at the office
• Family-Friendly Leave Policies, including Paternity Leave and Compassionate Leave, to support you through life's important moments