Job Description
As a Formulation Development Lead, you will be responsible for overseeing the development of generic products (excluding biosimilars) and representing formulation development in project teams.
Key Responsibilities:
* Lead and Coordinate: Oversee formulation and process development tasks, ensuring adherence to Quality by Design principles and current industry standards.
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* Oversee CDMO Activities: Manage formulation development and GMP manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs).
* Ensure Quality: Prepare high-quality registration documents for health authority submissions.
* Innovate and Solve: Proactively identify scientific and technological challenges and propose creative solutions.
* Collaborate: Work closely with cross-functional teams to ensure GxP activities are conducted in accordance with internal QMS.
* Technical Expertise: Provide guidance to troubleshoot development and manufacturing challenges.
Requirements
To be successful in this role, you will need:
* Educational Background: A PhD with 3 years of relevant experience, an MSc with 6 years of relevant experience, or a BSc/equivalent technical education with 10+ years of relevant experience in generic product development.
* Experience: Previous experience in oral solid dosage form generic product development.
* Agility: Proven experience in managing multiple tasks in parallel.
* Communication Skills: Demonstrated excellent communication and presentation skills.
* Regulatory Knowledge: Excellent understanding of regulatory expectations and requirements (US FDA, EMA, ANVISA).
* Teamwork: Experience working in cross-functional teams.
* Problem Solving: Proven track record of creativity, problem solving, and productivity.
* Writing Skills: Proficient scientific/technical writing skills.
* Languages: Fluent in English (oral and written); skills in German are welcome.
* Interpersonal Skills: Strong interpersonal skills and ability to work effectively in a team environment.