People Analytics Toolbox

Ask about this role

grounded in this role's JobFrame record + structure

Download this job's description (markdown) → derived live from this record.

Key statistics

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

5 of 8

Track

Management

Family rungs priced

M1 · M2 · M3 · M4 · M5 · M6

11-0000

manufacturing

Coordinates

3 / 4 spaces

pay@2 · 2026-07

What this role is

Directs CMC strategy and leads teams responsible for manufacturing processes, analytical controls, and regulatory compliance across a product portfolio. At the Senior Director (M5) level, the role owns multiple functions or a large department, org-level trade-offs and investment, and drives multi-function results. Leads directors and managers.

What this level does

Directs the CMC organization through department managers, impacting division-wide development and commercial manufacturing operations
Defines the methods and standards for CMC regulatory strategy across the full development lifecycle, including post-approval lifecycle management
Influences executives and major regulatory-agency counterparts on complex, org-wide CMC issues and precedent-setting negotiations
Builds and partners with a network of subject matter experts across diverse CMC product development areas to strengthen organizational capability

Knowledge applied: Defines org-wide CMC methods and regulatory-strategy standards across the full development lifecycle and post-approval management.
Complexity & problem solving: Tackles complex, division-wide CMC problems, defining approaches with business-wide implications.
Collaboration & interaction: Influences executives and major regulatory-agency counterparts on key strategic issues and builds SME networks.
Typical experience: 10–12+ years including second-level management and CMC strategy work.

Skills at this level

Core laboratory chemistry: — Directs synthesis and purification of drug substances and applies organic chemistry and chemical-safety knowledge to govern bench execution and troubleshooting.
CMC regulatory strategy: — Develops and manages content strategy for CMC submissions — INDs/CTAs and amendments, marketing applications, and supplements/variations — to enable first-pass health-authority approvals.
Technology transfer and manufacturing scale-up: — Leads transfer of drug substance and drug product processes from development into scaled manufacturing, ensuring readiness across upstream and downstream operations.
Statistical and trend analysis: — Uses statistical and trend analysis of process, stability, and analytical data to resolve OOS, OOT, stability, and manufacturing issues.
Health authority interaction: — Plans and manages regulatory agency interactions — responding to health authority questions and negotiating CMC positions during submission review.
Global regulatory strategy: — Manages global CMC regulatory strategy, agency negotiations, and corporate policy at senior and executive levels.
Cross-functional collaboration: — Works across regulatory affairs, quality assurance, and manufacturing to align CMC deliverables and ensure product integrity.
Full development lifecycle CMC input: — Provides strategic CMC guidance from early development through Phase 2b–3 pivotal studies, BLA/NDA submissions, and post-approval lifecycle management.
CMC practice development and business growth: — Builds the CMC service offering through business development, team building, and market-visibility activities at industry and client events.
Budget and resource ownership: — Owns CMC departmental budgets and vendor/resource allocation, shifting toward strategic vendor selection as scope grows.

Model-authored from 13 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 11-0000 · national

Employment growth 2019–2024, BLS OEWSobserved

+8.3%Architectural and Engineering Managers · United States

194,250 → 210,340 jobs

14,500 openings / year, split into:

replacement / exits 13,693

Growth — new jobs (6%)Exits — backfill (94%)

6% of hiring here is genuine expansion; the rest backfills people who move on.

Projected growth 2024–34 expanding: +3.8%
Growth share of hiring: 6%
Exit / retention pressure high: 94%
Openings / year: 14,500

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 M5 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$324k

San Francisco-Oakland-Fremont, CA$290k

Washington-Arlington-Alexandria, DC-VA-MD-WV$269k

Boulder, CO$265k

Seattle-Tacoma-Bellevue, WA$265k

Boston-Cambridge-Newton, MA-NH$254k

Lexington Park, MD$247k

Trenton-Princeton, NJ$246k

Pay only — metro-level demand isn't in public data (it needs job postings). National median $194k; 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 M5 (M5 — Senior Director) from the levels around it — this level only. Every word is real canon for this profile.

Scope: Multiple functions or a large department
Autonomy: Owns multi-year strategy for the area
Complexity: Org-level trade-offs and investment
Impact: Multi-function results
Decision rights: Owns investment and org design across functions
Leadership: Leads directors and managers

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

Promotion

The next rung from M5 is M6.

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
Staff CMC Scientist	jf_chemistry_manufacturing_controls_cmc::P5	$142,824	confident0.06
Lead CMC Specialist	jf_chemistry_manufacturing_controls_cmc::S5	$62,559	confident0.06
Senior Manager, Chemistry, Manufacturing & Controls	jf_chemistry_manufacturing_controls_cmc::M4	$173,021	confident0.06

Capability cluster

O*NET 11-9041

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

M5

jf_chemistry_manufacturing_controls_cmc::M5

Director, Chemistry, Manufacturing & Controls

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: M
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 · M5review0.17

Machine Shop · M5review0.17

Maintenance · M5review0.17

Manufacturing Engineering · M5review0.17

Pilot Plant Operations · M5review0.17

Production Test · M5review0.17

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 11-9041	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)