Formulation and Process Development Expert

1 week ago


København Huse, Denmark Black Swans Exist ApS Full time
Job Summary

We are seeking an experienced Formulation and Process Development Expert to join our team at Black Swans Exist ApS. The successful candidate will be responsible for the development and optimization of formulations for solid dosage forms containing Live Biotherapeutic Products (LBPs).

Main Responsibilities
  • Formulation Development:
    • Design, develop, and optimize formulations for solid dosage forms, taking into account excipient selection, drug-excipient interactions, and stability.
    • 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 Contract Development and Manufacturing Organizations (CDMOs) according to phase of development.
  • Technical Support:
    • Provide technical expertise during technology transfers, ensuring seamless integration of new processes.
    • Troubleshoot formulation and process-related issues during scale-up, utilizing problem-solving skills to resolve complex challenges.
    • Guide and ensure oversight of outsourced development and manufacturing activities, maintaining high-quality standards.
  • Quality and Compliance:
    • Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements, staying up-to-date with industry developments and guidelines.
    • Participate in internal and external audits, providing technical documentation and support as required.
  • Collaboration and Communication:
    • Work closely with cross-functional teams, including Research, Quality Assurance, and Regulatory Affairs, fostering a collaborative environment.
    • Communicate effectively with stakeholders to provide updates on formulation and process development activities, ensuring transparency and open dialogue.
    • Prepare and present technical reports, summaries, and presentations, effectively conveying complex information to various audiences.
  • Continuous Improvement:
    • Stay current with advancements in formulation technologies and industry trends, applying knowledge to drive innovation and improvement.
    • Identify opportunities for innovation and improvement in formulation and process development, proposing solutions to enhance efficiency and effectiveness.
    • Participate in professional development activities and training programs, maintaining a high level of expertise in relevant areas.
    Requirements
    • 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.
    Technical Skills:
    • Strong understanding of formulation principles, including excipient selection, drug-excipient interactions, and stability.
    • Proficiency in using pharmaceutical processing equipment and analytical instruments.
    • Experience with process simulation and modeling software is a plus.
    Soft Skills:
    • Excellent problem-solving and analytical skills.
    • Strong communication and interpersonal skills.
    • Ability to work effectively in a team-oriented, collaborative environment.
    Regulatory Knowledge:
    • Familiarity with GMP, FDA, EMA, and other relevant regulatory guidelines.
    • Experience with regulatory submissions and inspections is highly desirable.


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