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Solid Dosage Formulation Expert
3 weeks ago
Job Summary
We are seeking an experienced Solid Dosage Formulation Expert to join our team at Black Swans Exist ApS. The successful candidate will focus on the formulation and process development for solid dosage forms of Live Biotherapeutic Products (LBPs).
About the Role
- This role involves close collaboration with Research, Quality, and Regulatory teams to ensure the successful development and production of high-quality solid dosage forms.
- The candidate will be responsible for developing and optimizing formulations for solid dosage forms containing LBPs, supervising pre-formulation studies, and evaluating different excipients and delivery systems.
- Additionally, the expert will design and develop scalable manufacturing processes for solid dosage forms at partner CDMOs according to phase of development.
Responsibilities
- Develop and optimize formulations for solid dosage forms containing LBPs.
- Supervise pre-formulation studies, including compatibility and stability assessments.
- Evaluate different excipients and delivery systems to enhance the stability and efficacy of LBPs.
- Design and develop scalable manufacturing processes for solid dosage forms at partner CDMOs according to phase of development.
- Provide technical expertise during technology transfers and troubleshoot formulation and process-related issues during scale-up.
- Guide and ensure oversight of outsourced development and manufacturing activities.
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
- Participate in internal and external audits, providing technical documentation and support.
Requirements
- Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field.
- Minimum of 8 years of experience in pharmaceutical formulation and process development, with a focus on solid dosage forms.
- Experience with Live Biotherapeutic Products (LBPs) or other biologics is highly desirable.
About Us
Black Swans Exist ApS is a leading company in the field of pharmaceutical formulation and process development. We offer a dynamic and collaborative work environment, competitive compensation, and opportunities for professional growth and development.
