Head of Analytical Development Pharmaceutical

Overview

As the Head of Analytical Development Pharmaceuticals, you will lead the newly created department Analytical Development Pharmaceuticals aligning its direction with the global Development strategy. You will be responsible for all aspects of Drug Substance and Drug Product characterization, including method development, validation, and stability studies. Your leadership will ensure the department effectively supports global drug development and the seamless transfer to Operations.

Responsibilities

• Define and implement the global strategy for analytical development, supporting BI’s pipeline from early research through candidate characterization and selection to drug product development and launch.
• Lead core functional areas including preformulation, in vitro dissolution, method development, and quality control.
• Drive the Analytical Development leadership circle to ensure strategic goals are met across all NCE projects worldwide.
• Develop analytical methods for characterizing drug substances and drug products, focusing on content, dissolution, stability, and physicochemical properties.
• Validate and transfer analytical methods to support formulation and process development, enabling successful CMC submissions and product launches.
• Ensure analytical methods meet global regulatory standards, delivering robust, sensitive, and efficient solutions for quality control at commercial manufacturing sites.
• Maintain state-of-the-art laboratories, ensure personnel are trained and qualified, and implement efficient workflows to meet timelines and quality expectations.
• Foster innovation within the department, including the implementation of accelerated stability models and predictive stability testing.
• As a member of the Pharmaceutical Development leadership team, lead and develop the AD department, promote best practice sharing, and ensure proactive communication with internal and external stakeholders.

Requirements

• PhD or equivalent in Analytical Chemistry, Chemistry, Pharmaceutical Sciences or related field
• Proven experience in preformulation and NCE drug product development across multiple dosage forms, including late-stage development, manufacturing, pharmaceutical analysis, and regulatory affairs.
• Deep expertise in analytical techniques and instrumentation (e.g., HPLC, in vitro dissolution, GC, MS, KF, FTIR).
• Strong knowledge of regulatory environments (GMP, FDA, EU approval processes).
• Advanced understanding of statistical methods and process analytics.
• Several years of leadership experience managing global, cross-functional teams.
• Fluency in both German and English, with extensive experience in authoring analytical documentation in English.
• Willingness to travel internationally.

Contact

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) or via mail:

Recruitment process

1. Online application - The job posting is online until November 27th, 2025
2. Virtual meeting in the period from November 20th until December 2nd
3. On-site interviews mid of December (KW 51)

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