CMC Subject Matter Expert

Job Title:

Location:

Experience:

Domain:

Role type:

Replicant AI

hands-on CMC Subject Matter Expert

Roles & responsibilities

• Act as the

  CMC domain expert

  for our AI product, covering

  Module 3 (3.2.S / 3.2.P)

  end-to-end
• Provide deep insight into

  documentation types, data dependencies, and authoring workflows

  , including:

Drug Substance & Drug Product sections

Manufacturing processes & controls

Specifications, analytical methods, validation

Stability, comparability, lifecycle management

• Translate real-world CMC workflows into

  AI-ready product requirements

• Partner closely with

  product managers, AI engineers, and prompt designers

• Review and validate AI-generated outputs for

  regulatory accuracy, completeness, and intent

• Help define

  use cases, edge cases, and future roadmap

  for CMC automation
• Bring a reviewer / regulator mindset to improve robustness and defensibility of outputs

Qualifications:

• Strong experience owning or contributing to

  Module 3 regulatory submissions

  (US FDA, EMA, MHRA, WHO, etc.)
• Background in

  innovator, generics, biologics, or CRDMO environments

• Deep familiarity with

  CMC authoring, review, and lifecycle updates

• Ability to

  think structurally about documents

  , not just write them
• Curiosity and comfort working with

  AI tools, automation, or digital platforms

• Clear communicator who can bridge

  science, regulation, and product design

• Prior collaboration with

  IT, SaaS, or digital transformation teams

Why work with Replicant AI?

• You won’t just use software — you’ll

  help define how AI understands CMC

• Direct influence on a

  core life-sciences AI product

  , not a side project
• Opportunity to apply decades of CMC knowledge at

  platform scale

• Work with a founding team deeply focused on

  real pharma problems

  , not generic AI demos

multiply your impact through AI