Solid Dosage Forms Development Expert

2 weeks ago


København Huse, Denmark Black Swans Exist ApS Full time

About the Role
At Black Swans Exist ApS, we are seeking a highly skilled Principal Drug Product Formulation and Process Specialist – Solid Dosage Forms to join our team. This is a unique opportunity to leverage your expertise in formulation and process development to drive the success of our Live Biotherapeutic Products (LBPs).

Key Responsibilities
As a Principal Drug Product Formulation and Process Specialist – Solid Dosage Forms, you will be responsible for the development and optimization of formulations for solid dosage forms containing LBPs. This will involve close collaboration with our Research, Quality, and Regulatory teams to ensure the successful development and production of high-quality solid dosage forms at partner CDMOs.

Key Responsibilities
Specifically, your responsibilities will include:

  • Developing and optimizing formulations for solid dosage forms containing LBPs
  • Supervising pre-formulation studies, including compatibility and stability assessments
  • Evaluating different excipients and delivery systems to enhance the stability and efficacy of LBPs
  • Designing and developing scalable manufacturing processes for solid dosage forms at partner CDMOs according to phase of development
  • Providing technical expertise during technology transfers
  • Troubleshooting formulation and process-related issues during scale-up
  • Guiding and ensuring oversight of outsourced development and manufacturing activities
  • Ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory requirements
  • Participating in internal and external audits, providing technical documentation and support

Requirements
To be successful in this role, you will need:

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. Ph.D. preferred
  • 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 dynamic and innovative company dedicated to the development of Live Biotherapeutic Products (LBPs). We are committed to delivering high-quality products that meet the needs of our customers and stakeholders.



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