Position Summary: The Drug Product Formulation and Process Specialist will focus on the formulation and process development for solid dosage forms of Live Biotherapeutic Products (LBPs). This role involves close collaboration with Research, Quality, and Regulatory teams to ensure the successful development and production of high-quality solid dosage forms at partner CDMOs.

Key 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.

Qualifications:

Education:

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. Ph.D. preferred.

Experience:

• 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.