Formulation Development Leader
5 giorni fa
About Suedheide Geniessen
">At Suedheide Geniessen, we're pushing the boundaries of pharmaceutical innovation. We're a community of passionate experts driven by a shared purpose: to improve patients' lives through groundbreaking science.
">Job Title: Formulation Development Leader - Sterile Dosage Forms Expert
">Job Description:
">We're seeking an exceptional Formulation Development Leader - Sterile Dosage Forms Expert to lead our formulation development team in creating cutting-edge sterile dosage forms. This role requires expertise in liquid sterile dosage forms, with a strong understanding of drug product production and control technologies. The ideal candidate will have a PhD in Pharmaceutics or related sciences, with at least 3 years of experience in the pharmaceutical industry. A Master's degree with 5 years of experience is also considered. Fluency in English (oral and written) is essential, with desirable knowledge of site language.
">Responsibilities:
">- ">
- Lead the development of formulations and manufacturing processes for sterile dosage forms.">
- Support the qualification of analytical methods together with the AS&T team leader, adhering to ICH guidelines and internal SOPs.">
- Participate as a formulation expert in cross-functional project teams.">
- Be accountable for all formulation and manufacturing process deliverables, including scientific documentation.">
- Ensure timely start of development trials, process transfers, and supply activities through accurate and comprehensible documentation.">
- Draft CMC documents required for regulatory submissions (IND/IMPD, Module3/NDA).">
- Provide technical guidance to team members and work according to appropriate SOPs, GLP, GMP, HSE, and AdAcAp guidelines.">
- Proactively communicate key issues and critical topics to management levels and relevant project team members.">
Requirements:
">The successful candidate will have:
">A PhD in Pharmaceutics or related sciences with at least 3 years of experience in the pharmaceutical industry or a Master's degree with 5 years of experience.
">Fluency in English (oral and written) is essential, with 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.
">Experience in writing CMC documents for regulatory submissions and responding to health authority questions.
">Good basis of Quality Assurance (overall knowledge of GxPs).
">Estimated Salary: €90,000 - €120,000 per annum, depending on qualifications and experience.
">Why Work with Us?
">We offer a dynamic and inclusive work environment, where you can grow professionally and make a meaningful impact on patients' lives. Our competitive salary package includes benefits such as health insurance, retirement plans, and paid time off.
">Join Our Network
">If this role isn't the right fit for you, consider joining our talent community to stay connected and learn about suitable career opportunities as they arise.
">Suedheide Geniessen is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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