Job Title
Site Director / Managing Director (m/f/d)
Drug Substance Manufacturing – Chemical APIs
Location: Munich Area, Germany
Role Overview
We are seeking an experienced Site Director / Managing Director to lead a GMP-regulated drug substance (API) manufacturing site within a growing chemical CDMO organization. The site specialises in small-molecule chemical APIs, supplying both custom development and commercial manufacturing to global pharmaceutical customers.
The role carries full P&L responsibility and end-to-end accountability for site performance, including operations, quality, EHS, engineering, supply chain, and people leadership. You will act as the senior legal and operational representative of the site and play a key role in shaping its long-term strategy and growth.
Key Responsibilities
Site & Business Leadership
* Full responsibility for site performance, including safety, quality, delivery, cost, and people
* P&L ownership, budgeting, forecasting, and cost control
* Translate group strategy into a clear site roadmap, aligned with customer and regulatory requirements
* Act as the senior representative for the site with corporate leadership, customers, auditors, and local authorities
Operations & Manufacturing
* Lead chemical API manufacturing operations across production, technical operations, maintenance, and supply chain
* Ensure robust GMP compliance for drug substance manufacturing in line with EU and FDA expectations
* Drive operational excellence, capacity optimisation, and continuous improvement initiatives
* Oversee technology transfer, scale-up, and commercial manufacturing activities
Quality, EHS & Regulatory
* Foster a strong quality and safety culture across the site
* Ensure inspection readiness for EU, FDA, and customer audits
* Maintain compliance with German regulatory, environmental, and occupational safety requirements
* Partner closely with Quality and EHS leadership to proactively manage risk
People & Organisation
* Lead and develop the site leadership team
* Build a high-performance, accountable, and engaged organisation
* Support succession planning, talent development, and organisational capability building
* Act as a visible and credible leader on the shop floor and across functions
Capital Projects & Growth
* Lead CAPEX planning and execution, including plant upgrades and capacity expansions
* Support customer interactions, site visits, and technical due diligence as part of business development efforts
* Contribute to strategic decisions around new technologies, investments, and product platforms
Required Experience & Qualifications
Education
* Degree in Chemistry, Chemical Engineering, Pharmacy, or related technical discipline
* Advanced degree (PhD, MBA) is a plus but not essential
Experience
* Significant leadership experience in pharmaceutical or chemical manufacturing, ideally within:
* API manufacturing
* CDMO or contract manufacturing environments
* Proven track record in site-level leadership roles (e.g. Site Director, Plant Manager, Operations Director, GM)
* Strong experience with chemical synthesis and drug substance manufacturing
* Demonstrated ownership of P&L and large operational teams
* Experience leading CAPEX projects and operational change
Technical & Regulatory
* Deep understanding of GMP requirements for API manufacturing
* Experience interacting with EU and FDA regulators
* Strong operational and technical credibility in a regulated chemical environment
Language
* Fluent German and English (spoken and written) required
Key Leadership Competencies
* Strong, authentic people leadership style
* Decisive, structured, and commercially minded
* Comfortable operating in complex, regulated environments
* Able to balance customer expectations, compliance, and operational efficiency
* Resilient, hands-on, and visible leader
Why This Role
* Senior leadership position with real autonomy and impact
* Opportunity to lead a strategically important API manufacturing site
* Long-term growth platform within a European CDMO
* High visibility with group leadership and global customers