Formulation Development Expert
2 giorni fa
About Suedheide Geniessen
Suedheide Geniessen is a dynamic company that offers a unique opportunity to work with innovative science and make a meaningful impact on patients' lives.
We are seeking an experienced Formulation Development Expert to join our team in [location].
Job Description:
- Lead the development of formulations and manufacturing processes for Drug Products, focusing on liquid sterile dosage forms.
- Collaborate closely with operations, analytics, engineering, and relevant SMEs, QA, and project DPPL teams.
- Develop and drive scientific documentation, including formulation and process design, control strategy, quality risk management, and manufacturing instructions.
- Support the qualification of analytical methods with the AS&T team leader, adhering to ICH guidelines and internal SOPs.
- Participate as a formulation expert in cross-functional project teams and guarantee technical support throughout the project life cycle.
- Author accurate, comprehensible, structured, complete, and legible documents for timely start of development trials, process transfers, and supply activities.
- Draft CMC documents required for regulatory submissions (IND/IMPD, Module3/NDA).
Required Skills and Qualifications:
- PhD in Pharmaceutics or related sciences with a minimum of 3 years of experience in the pharmaceutical/biotech industry or a Master's degree with a minimum of 5 years of experience.
- Fluent knowledge of English (oral and written) and desirable knowledge of site language.
- Demonstrated success in developing formulations with an emphasis on liquid sterile dosage forms.
- Technical expertise and detailed understanding of drug product production and control technologies.
- Experience with outsourcing and supervising work done by CRO/CMOs, including technical overview of agreement setup.
- Good basis of Quality Assurance (overall knowledge of GxPs).
Benefits:
- A competitive salary of approximately €80,000 - €110,000 per year, depending on location and experience.
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
- The opportunity to work with a dynamic company that values innovation and collaboration.
Others:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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