Hikma Pharmaceuticals purpose is to put better health, within reach, every day for millions of patients around the world. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

We are building Generics R&D in Zagreb, Croatia and this position is a unique opportunity to be involved in initiating lifesaving development programs from the beginning. In this role you will be given the freedom to handle a wide variety of tasks in collaboration with a large part of the organization. But also, in more general terms, Hikma offers an exciting opportunity to contribute and grow.

 

Associate Director, Analytical development, Generics R&D (m/f/d)

Location: Zagreb

Key Responsibilities:

Leads the Analytical development department within Generics R&D, responsible for development of analytical methodology for oral generics, including: development and validation of analytical methods analytical method transfers to QC at manufacturing sites or CROs people development budget planning and execution. Participation in definition of facility design, capital investments, equipment selection and project execution to deliver fit for purpose Laboratory for analytical development for oral generics at Zagreb site. Creates comprehensive analytical development strategy that considers both US and worldwide quality and regulatory requirements. Recognizes issues and potential barriers, defines problems, identifies underlying principles, reasons, or facts, determines appropriate solutions, and utilizes resources to drive improvements of medium to high complexity. Assures optimal and efficient analytical development for oral generics within project timelines and budget, with delivery of regulatory documents for submissions in compliance with high quality and regulatory requirements of global markets (US, EU). Evaluates performance, providing coaching and ensuring direct reports are developing appropriate skills to meet the needs of the business. Keeps current in analytical methodologies and regulatory guidance’s best practices and their implementation to support company strategy. Effectively enables strong collaboration within multi-disciplinary teams at a local and global company level.

 

 What We Expect:

Bachelors, Masters, or advanced degree in Pharmacy/Chemistry/Chemical engineering or similar scientific field Minimum of 12 years of R&D experience in pharmaceutical industry; minimum 5 years of experience in leading multi-disciplinary teams Extensive experience in analytical development for oral generics Demonstrated experience of creative problem-solving attitude in development of final dosage forms including leading/motivating a team to meet development deadlines Demonstrated ability in the preparation of ANDA documentation (authoring and compilation of Module 3 documents) Strong presentation skills, meeting facilitation skills, verbal and written communication skills Ability to influence others by presenting alternative options persuasively Effectively processes thoughts quickly and accurately from one project to another Fluency in English language (spoken and written)

What We Offer:

Permanent full-time position A dynamic work environment Opportunities to interact with colleagues at all levels, as well as clients and customers Competitive compensation package Annual health check-up Monthly food and travel allowances