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Senior Formulation and Process Development Specialist for Solid Dosage Forms
2 months ago
Job Overview:
We are seeking an experienced Senior Formulation and Process Development Specialist to join our team at Black Swans Exist ApS in Copenhagen.
About the Role:
The successful candidate will be responsible for leading the formulation and process development of solid dosage forms for Live Biotherapeutic Products (LBPs). This role involves close collaboration with cross-functional teams, including Research, Quality Assurance, and Regulatory Affairs, to ensure the successful development and production of high-quality solid dosage forms at partner Contract Development and Manufacturing Organizations (CDMOs).
Main Responsibilities:
- Formulation Development:
- 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.
- Process Development:
- Design and develop scalable manufacturing processes for solid dosage forms at partner CDMOs according to phase of development.
- Technical Support:
- Provide technical expertise during technology transfers.
- Troubleshoot formulation and process-related issues during scale-up.
- Guide and ensure oversight of outsourced development and manufacturing activities.
- Quality and Compliance:
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
- Participate in internal and external audits, providing technical documentation and support.
- Collaboration and Communication:
- Work closely with cross-functional teams, including Research, Quality Assurance, and Regulatory Affairs.
- Communicate effectively with stakeholders to provide updates on formulation and process development activities.
- Prepare and present technical reports, summaries, and presentations.
- Continuous Improvement:
- Stay current with advancements in formulation technologies and industry trends.
- Identify opportunities for innovation and improvement in formulation and process development.
- Participate in professional development activities and training programs.
To be considered for this position, you must have a Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. A Ph.D. is preferred. Additionally, you should have a 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.
What We Offer:
We offer a competitive salary of approximately €80,000 - €100,000 per year, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
As a valued member of our team, you will have the opportunity to work on exciting projects, collaborate with talented professionals, and contribute to the development of innovative pharmaceutical products.
If you are passionate about formulation and process development, enjoy working in a dynamic team environment, and are looking for a new challenge, we encourage you to apply for this exciting opportunity.
