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Director, Process & Analytical Development

US - Walkersville MD - REMOTE🌐 Remote💼 Full-time💰 $196,700–$196,700🗓 2026-08-17 → 2026-09-26

Core

Provide overall leadership for analytical development, process development, and project-specific manufacturing activities to ensure safe, compliant, and on-time delivery of services and products aligned with business objectives.

Role type

Director, Process & Analytical Development

Builds

Analytical and process development capabilities, manufacturing infrastructure, and operational readiness for future business growth.

Domain

Pharmaceutical manufacturing, biotechnology, CDMO, small molecule and bioconjugate technologies.

Deliverable

production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work

Required skills

Strategic planning, portfolio management, organizational design, performance management, Lean maturity, technology evaluation, stakeholder influence, budget ownership, facility startup/expansion leadership, GMP compliance, technology transfer, operational scale-up, capital program management.

Preferred skills

PhD in relevant field, experience with automation and digital systems, data integrity principles, navigating ambiguity in fast-paced environments.

Technologies

GMP, Lean Manufacturing, Six Sigma, automation, digital systems.

Responsibilities

Lead and develop a high-performing organization; define and execute strategic direction; establish capabilities and infrastructure for future operations; serve as a key contributor to Sales & Operations Planning; provide leadership for development and manufacturing activities; maintain ownership of budgets and operational performance; drive Lean maturity and transformation programs; partner with cross-functional teams for technology transfer and commercialization; establish governance processes; support site startup, facility expansion, and validation initiatives.

Seniority

Director, strategic leadership & organizational building

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