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Key statistics

The identity block — every fact is canon, none is generated.

4 of 8

Track

Individual contributor

Family rungs priced

P1 · P2 · P3 · P4 · P5 · P6

19-0000

manufacturing

Coordinates

3 / 4 spaces

pay@2 · 2026-07

What this role is

Senior individual contributor responsible for developing and managing CMC documentation and process controls for pharmaceutical manufacturing. At the Senior Professional (P4) level, the role owns a system or set of related features, devises new approaches, and drives multi-team / function outcomes. Technical lead for focused efforts; mentors several.

What this level does

Lead the CMC strategy for a program end-to-end, selecting process-development and control-strategy methods and defending them in direct interactions with regulatory agencies
Conduct in-depth analysis of complex, interdependent variables — process robustness, analytical variability, stability trends — to shape the control strategy for a new chemical entity
Coordinate CMC deliverables across process chemistry, analytical, QA, manufacturing and regulatory groups, resolving cross-functional conflicts and influencing filing decisions
Author and finalize the high-complexity CMC sections of major submissions (NDA, BLA, MAA) and own the strategy for responding to agency deficiency letters
Lead health-authority interactions and meetings for the program's CMC content, and may supervise or mentor junior CMC scientists on submission work

Knowledge applied: Applies in-depth CMC and regulatory knowledge to complex, program-wide control-strategy and submission problems, selecting the methods used.
Complexity & problem solving: Performs in-depth analysis of complex, interdependent manufacturing, analytical and stability variables to shape a defensible control strategy.
Collaboration & interaction: Coordinates across process, analytical, QA and regulatory groups, influences filing decisions and leads agency interactions; may supervise junior scientists.
Typical experience: 8+ years, often with graduate education in chemistry or a related discipline.

Skills at this level

Synthetic organic / process chemistry: — Develops and optimizes synthetic routes and manufacturing processes for drug substance, taking API process development through to cGMP drug-substance manufacturing for clinical supply.
Statistical and trend analysis: — Applies statistical and trend-analysis methods to CMC datasets to detect and resolve out-of-specification (OOS), out-of-trend (OOT), stability and manufacturing anomalies.
CTD authoring and submission assembly: — Builds and formats Common Technical Document (CTD) modules and assembles the CMC sections of IND, IMPD, NDA, sNDA, BLA and MAA submissions to meet the requirements of one or more health authorities.
cGMP batch and quality documentation review: — Reviews batch records, Certificates of Analysis, validation, stability, deviation and CAPA reports to confirm they support product integrity and regulatory adequacy.
Technology transfer: — Provides technical support to transfer analytical methods and manufacturing processes between sites or scales, ensuring manufacturing readiness for clinical API production.
CMC regulatory strategy: — Plans and defends the CMC control strategy across programs, managing post-approval supplements, annual reports, registration renewals and the sequence of filings for a new chemical entity.
Health authority interaction: — Serves as point of contact for regulatory agencies, drafting responses to health authority questions and negotiating CMC positions in submissions, meetings and pre-approval inspections.
CMC investigation and problem resolution: — Applies chemistry and biotechnology expertise to investigate manufacturing and control problems for API and drug products, driving OOS, OOT, stability and deviation issues to root cause.
Luminata CMC decision support: — Uses Luminata (ACD/Labs) to consolidate process, analytical and impurity data and manage CMC decision-support and control-strategy justification across the drug-development lifecycle.

Model-authored from 15 retrieved sources, then adversarially reviewed by an independent judge panel and held to a minimum-evidence floor before publication. Distinct from corpus-extracted content, which is labelled as such.

Pay across the ladder

Chemistry, Manufacturing & Controls (CMC) — median with , by . Real canon data.

Pay figures are modeled estimates from our market equation — level-differentiated, with honest-wide bands. They refresh as new leveling evidence lands; treat per-role dollars as directional.

Demand — is the field growing, or just turning over?

SOC 19-0000 · national

Employment growth 2019–2024, BLS OEWSobserved

-0.3%Chemists · United States

83,530 → 83,250 jobs

6,300 openings / year, split into:

replacement / exits 5,875

Growth — new jobs (7%)Exits — backfill (93%)

7% of hiring here is genuine expansion; the rest backfills people who move on.

Projected growth 2024–34 expanding: +4.9%
Growth share of hiring: 7%
Exit / retention pressure high: 93%
Openings / year: 6,300

Two quantities, kept apart: observed = employment growth differenced from two BLS OEWS vintages (what already happened); projected = BLS Employment Projections 2024–34, openings decomposed into growth + exits (growth derived from projected employment change). Neither is a pay figure.

Where this role sits — growth vs. pay

level P4 held

Demand axis is projected growth (not raw openings — that just measures churn). A curated, de-duplicated set of recognizable occupations held at this level; this role is highlighted.

Where it pays — by metro

OEWS metro median

San Jose-Sunnyvale-Santa Clara, CA$188k

San Francisco-Oakland-Fremont, CA$169k

Washington-Arlington-Alexandria, DC-VA-MD-WV$156k

Boulder, CO$154k

Seattle-Tacoma-Bellevue, WA$154k

Boston-Cambridge-Newton, MA-NH$147k

Lexington Park, MD$144k

Trenton-Princeton, NJ$143k

Pay only — metro-level demand isn't in public data (it needs job postings). National median $113k; the demand-cube initiative will add growth-by-metro.

What changes across the ladder

Level-distinction canon isn't available for the adjacent levels of this profile yet.

Level differentiators

What separates P4 (P4 — Senior Professional) from the levels around it — this level only. Every word is real canon for this profile.

Scope: A system or set of related features
Autonomy: Self-directed; reviewed at critical decision points
Complexity: Complex, ambiguous problems; devises new approaches
Impact: Multi-team / function outcomes
Decision rights: Owns technical decisions for a system; influences adjacent design
Leadership: Technical lead for focused efforts; mentors several

Full level-by-level matrix (side by side across the ladder) lives on the Ladder drill-down — not here.

Promotion

The next rung from P4 is P5.

Performance criteria for this profile render in the assessment kit →

People also watch

Nearest coordinate neighbors — same , same level. Each row's (confident / review / no match) comes from its — computed, not curated.

Profile	Key	Median	Δ structural
Chief CMC Officer	jf_chemistry_manufacturing_controls_cmc::E4	$401,582	confident0.06
Senior Manager, Chemistry, Manufacturing & Controls	jf_chemistry_manufacturing_controls_cmc::M4	$173,021	confident0.06
Advanced CMC Associate	jf_chemistry_manufacturing_controls_cmc::S4	$58,202	confident0.06
CMC Scientist	jf_chemistry_manufacturing_controls_cmc::P3	$85,090	confident0.06

Capability cluster

O*NET 19-2031

Core to this role. Click any element with an ⓘ for its O*NET definition. A job-specific capability model (SkillFrame) will sharpen this and add worked examples.

The Job Swatch

P4

jf_chemistry_manufacturing_controls_cmc::P4

Senior CMC Specialist

Chemistry, Manufacturing & Controls (CMC)

The swatch is JobFrame's core primitive: a hueset deterministically by the role's superfunction, the profileKey as its color code, the level ladder, and a content fingerprint. Two swatches that look alike are alike.

Because every role carries computable coordinates, similarity, leveling, and pricing become measurable instead of arguable— the whole point of "Pantone for jobs."

Structural

structural@1

Where it sits— position in the work taxonomy + level (weighted Gower, level > function > focus).

Track: P
Superfunction: manufacturing
Function: manufacturing_expansion
Family: chemistry_manufacturing_controls_cmc
Universal level: 4 / 8

Content

content@2

What it's about— a fingerprint over the role's tasks & capabilities.

Two roles can sit far apart structurally yet be close in content — that gap is itself a signal.

3-state matching

How any two swatches compare — a real distance in coordinate space, resolved to a calibrated verdict (never a fake "94% match").

Lean Manufacturing · P4review0.17

Machine Shop · P4review0.17

Maintenance · P4review0.17

Manufacturing Engineering · P4review0.17

Pilot Plant Operations · P4review0.17

Production Test · P4review0.17

Editions — frozen & versioned

structural@1live

Released 2026-06-17

content@2live

Released 2026-07-28

pay@2live

Released 2026-07-02

semantic@1live

Released 2026-07-02

Coordinates belong to a frozen, versioned edition — a coordinate computed today still means the same thing next quarter. Re-fitting issues a new edition, so comparisons are never silently redefined.

How to read this profile

Every number here is traceable — to a named source, a stated method, and an as-of date — and each value is labeled by how we know it: observed from data, computed by a model, projected forward, or governed canon. Nothing is a black box, and nothing is invented to fill a gap.

Where every number comes from

What	Source & method	Edition	State
Median pay + range	JobFrame pay equation (function base × family multiplier × level × focus differential)	pay@2	computed
Pay across the ladder	Same equation applied at each universal level	pay@2	computed
Demand — growth & openings	BLS Employment Projections; openings decomposed into growth + exits	EP 2024–34	projected
Pay by metro	BLS OEWS metropolitan medians	OEWS 2024	observed
Level distinctions	JobFrame universal-level canon (scope · autonomy · complexity · impact · decision rights · leadership)	canon	canon
Capability cluster	O*NET Knowledge / Skills / Abilities	O*NET 19-2031	computed
Coordinates	JobFrame coordinate system — structural (weighted Gower) + content fingerprint	structural@1 · content@2 · pay@2 · semantic@1	computed
Related roles	Nearest neighbors in the structural coordinate space	structural@1	computed

The principles behind the numbers

Ranges, not false precision

Pay is P10 · median · P90, never a single misleading number.

Three honest states, never a fake %

Role matches resolve to confident / review / no-match — a calibrated verdict, not a made-up percentage.

Provenance on every value

Each number carries whether it's observed, computed, projected, or canon — so you always know how much to lean on it.

Gaps shown as gaps

When a figure isn't available at the grain you need, we say so — we don't fabricate a number to fill the cell.

Frozen, versioned editions

Pay and coordinate editions are pinned, so a comparison you make today still means the same thing next quarter.

Privacy by min-N

Any aggregate over people is suppressed below a minimum count, so no individual is identifiable.

Freshness

As of2026-07-30Editioncanon-v2@2.1.0-completeSourcecanon-v2 cell + salary-benchmark (model)