Formulation Scientist

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Sandoz

Lead and Coordinate: Oversee the formulation and process development tasks for generic products (excluding biosimilars) and represent formulation development in project teams.
Manage Activities: Handle all formulation-related activities for the development of oral solid dosage forms, ensuring adherence to Quality by Design principles and current industry standards.
Develop Formulations: Develop small molecule solid-oral dosage formulations, including assessing API properties, evaluating formulation approaches, and designing experiments.
Oversee CDMO Activities: Manage formulation development and GMP manufacturing activities at CDMOs, communicate effectively, and monitor deliverables.
Ensure Quality: Prepare high-quality registration documents for health authority submissions and act as a technical expert during audits and inspections.
Innovate and Solve: Proactively identify scientific and technological challenges, propose creative solutions, and communicate key issues promptly to management.
Collaborate: Work closely with cross-functional teams to identify risks and solutions and ensure GxP activities are conducted in accordance with internal QMS.
Technical Expertise: Provide guidance to troubleshoot development and manufacturing challenges and be present on-site for batch manufacturing activities as needed.
Documentation: Author and review internal technical reports and drug product sections of regulatory filings.

Educational Background: PhD with 3 years relevant experience, MSc with 6 years relevant experience, or BSc/equivalent technical education with 10+ years 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, understanding the importance of relationships, and being a team player.
Leadership: A leader who mentors and supports the careers of others and is willing to roll up their sleeves to get the job done.