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Key statistics

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

5 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

An expert individual contributor who designs and oversees chemistry, manufacturing, and controls strategies for complex pharmaceutical or biotech products. At the Expert Professional (P5) level, the role owns multiple systems or a technical domain, establishes the approach, and drives org / multi-team outcomes. Leads cross-team technical initiatives.

What this level does

Own CMC strategy across multiple programs rather than executing within a single program, setting the manufacturing-science and regulatory approach for a portfolio
Serve as the responsible subject-matter expert in Regulatory CMC with demonstrated experience filing a successful NDA/MAA for a new chemical entity, holding direct influence on decision-making within CMC-related activities
Act independently on broad or unprecedented control-strategy problems — novel modality, contested stability specification, first-in-class process — where standard answers do not exist
Represent the organization as CMC spokesperson in high-stakes agency negotiations and pre-approval inspections, building influential networks across regulators and partners
Establish CMC positions and precedents that other programs adopt, and mentor P3/P4 scientists on strategy for special or difficult assignments

Knowledge applied: Applies expert, cross-program CMC mastery to strategic and unprecedented control problems, contributing directly to company development objectives.
Complexity & problem solving: Resolves intangible, ambiguous problems where standard answers are absent — novel modalities, contested specifications — with high independence.
Collaboration & interaction: Builds influential regulator and partner networks and acts as the CMC spokesperson in high-stakes negotiations and inspections.
Typical experience: 12+ years with extensive CMC and regulatory expertise, including a successful NDA/MAA filing for a new chemical entity.

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 P5 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$238k

San Francisco-Oakland-Fremont, CA$213k

Washington-Arlington-Alexandria, DC-VA-MD-WV$197k

Boulder, CO$195k

Seattle-Tacoma-Bellevue, WA$195k

Boston-Cambridge-Newton, MA-NH$186k

Lexington Park, MD$182k

Trenton-Princeton, NJ$181k

Pay only — metro-level demand isn't in public data (it needs job postings). National median $143k; 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 P5 (P5 — Expert Professional) from the levels around it — this level only. Every word is real canon for this profile.

Scope: Multiple systems or a technical domain
Autonomy: Sets direction within the domain
Complexity: Novel, high-ambiguity problems; establishes the approach
Impact: Org / multi-team outcomes
Decision rights: Authority over a technical domain
Leadership: Leads cross-team technical initiatives

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

Promotion

The next rung from P5 is P6.

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::E5	$351,571	confident0.06
Director, Chemistry, Manufacturing & Controls	jf_chemistry_manufacturing_controls_cmc::M5	$194,360	confident0.06
Lead CMC Specialist	jf_chemistry_manufacturing_controls_cmc::S5	$62,559	confident0.06
Senior CMC Specialist	jf_chemistry_manufacturing_controls_cmc::P4	$112,946	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

P5

jf_chemistry_manufacturing_controls_cmc::P5

Staff CMC Scientist

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: 5 / 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 · P5review0.17

Machine Shop · P5review0.17

Maintenance · P5review0.17

Manufacturing Engineering · P5review0.17

Pilot Plant Operations · P5review0.17

Production Test · P5review0.17

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 of2026-07-31Editioncanon-v2@2.1.0-completeSourcecanon-v2 cell + salary-benchmark (model)