* 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.
What You’ll Bring to the Role:
* 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.
What We Offer:
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. For this position the minimum salary is € 64.023,54/year (on a full time basis). We also offer a potential market-oriented excess payment in line with your experience and qualifications.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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