CMC Consultant
Job description
About the role
The role advances Chemistry, Manufacturing & Controls strategy for an at-home device-enabled therapeutic. It guides the lead asset through the NDA pathway while coordinating drug product development, analytical strategy, and device integration. The position delivers strategic direction and tactical oversight alongside a lean internal team and external partners.
Software engineers turn product ideas into working code. Engineers work in small teams, review each other's work, and ship in small batches. Most teams follow agile practices such as sprints and daily standups. Engineers also write tests, fix bugs, and improve performance. The field values clear communication as much as technical skill. Engineers spend part of every week on planning, code review, and debugging, not just writing new code. The ability to explain a technical decision in plain words separates strong engineers from the rest.
Key facts
What you'll do
Formulation, stability, and device compatibility align with clinical progression and trial readiness to define critical quality attributes, specifications, and acceptance criteria.
CDMOs, CROs, and suppliers coordinate timelines and technical deliverables, and the candidate reviews deliverables, ensures timelines are met, and mitigates technical risks across CMC activities.
IND submission activities are shaped through organizing and contributing to CMC strategy and regulatory documents such as briefing packages and NDA modules.
Program clearance advances through preparing for and supporting FDA interactions, including IND, EOP2, and Type C meetings.
Requirements
Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field requires advanced knowledge, though a formal degree is not required.
The candidate brings 10+ years of drug development experience with demonstrated leadership of CMC strategy in biotech or pharmaceutical settings.
Formulation development, analytical method development and validation, stability programs, GMP manufacturing, and quality compliance require strong expertise.
INDs and/or NDAs support relies on a strong track record from the candidate.
Independence operates in a fast-paced, dynamic startup environment.
Nice to have
Combination products that include a drug and a delivery device are preferred for the candidate.
FDA interactions on CMC topics prior to application are advantageous.
Program support spans early clinical through late-stage development.
Practical notes
This role operates on a fractional, contract basis with remote work based in the US.
Typical interview steps
Hiring for engineering roles usually starts with a recruiter screen, followed by one or two technical rounds. Candidates often solve a coding problem, discuss past projects, and answer system design questions. Some loops include a take-home task. Final rounds typically cover team fit and give candidates a chance to ask questions. Interviewers look for how you break down an unfamiliar problem, not just whether you reach the answer. Practicing a few problems aloud and reviewing your own past projects are the best preparation.
Good to know
CMC consultants bridge science, regulatory strategy, and manufacturing quality in drug development.
These roles often operate at the intersection of formulation, analytical methods, and compliance for complex therapies.
Combination products that integrate drugs and delivery devices require cross-functional expertise and close coordination.
Regulatory acceptance depends on data integrity, validated methods, and readiness for inspections.
This role typically involves advisory and execution responsibilities in fast-paced, mission-driven environments.
Career growth
Engineering careers usually progress from individual contributor to senior, staff, and principal levels. Some engineers move into management and lead teams of five to twenty people. Others stay on the technical track. Growth follows demonstrated impact, not tenure alone. A typical engineering ladder has clear levels with defined expectations for scope, quality, and mentorship. Moving up usually requires owning outcomes end to end rather than completing assigned tickets.
About the company
Atomic is a venture studio. We don't take pitches. We build companies as co-founders.