Manager Formulation & Development Tech Transfer

Position Title:

Location:

Job Overview:

The Manager – Formulation & Development will oversee the successful transition of products from development (R&D or other manufacturing sites) to commercial manufacturing. This role requires in-depth expertise in technology transfer, quality control, scale-up processes, and regulatory compliance, ensuring seamless manufacturing operations and product quality.

Key Responsibilities:

1. Review of Technology Transfer Dossier (TTD):

• Conduct detailed reviews of TTDs to ensure accuracy, completeness, and alignment with manufacturing capabilities.
• Assess process flow, raw material specifications, equipment needs, and facility requirements.
• Evaluate scalability and identify bottlenecks or challenges in transitioning from lab scale to full-scale production.

2. Assessment of Manufacturing Feasibility:

• Analyse the feasibility of transferring technologies to manufacturing, including processes, equipment, and facilities.
• Mitigate potential issues related to scale-up and manufacturing variability.
• Ensure reproducibility of the process in a commercial manufacturing environment while maintaining product quality.

3. Collaboration with Cross-functional Teams:

• Partner with R&D, Regulatory Affairs, Quality Assurance, and Production teams to streamline the technology transfer process.
• Act as a bridge between development and manufacturing teams, addressing concerns and optimizing processes.
• Participate in and facilitate meetings to review progress and provide actionable feedback.

4. Evaluation of Process Validation Plans:

• Review process validation strategies, protocols, and acceptance criteria.
• Ensure validations align with manufacturing capacity and regulatory requirements.
• Assess results of process qualification and validation batches to guarantee robustness.

5. Risk Assessment and Mitigation:

• Conduct risk assessments to identify critical control points, potential failure modes, and quality risks.
• Develop and implement quality control measures in collaboration with the quality team.
• Propose process, equipment, or material modifications to enhance manufacturability and reduce costs or risks.

6. Compliance and Documentation:

• Ensure adherence to local and international regulatory requirements (e.g., FDA, EMA, ICH).
• Review TTD documentation for regulatory alignment and maintain accurate records for inspections.

7. Troubleshooting and Problem Solving:

• Provide technical support during initial manufacturing runs and address product or process issues.
• Identify gaps or inconsistencies in the process and implement corrective actions.

8. Continuous Improvement:

• Recommend improvements based on TTD reviews and manufacturing performance.
• Identify opportunities to enhance efficiency, cost-effectiveness, and product quality.

Key Skills:

Technical Skills:

• Expertise in manufacturing processes, equipment, and scale-up principles.
• Knowledge of analytical techniques and quality control measures.
• Ability to interpret complex technical documents and implement actionable manufacturing strategies.

Soft Skills:

• Strong communication and interpersonal skills for effective cross-functional collaboration.
• Problem-solving skills to address complex manufacturing challenges.
• Analytical thinking and attention to detail.

Qualifications & Experience:

• Education:

  Master's degree in Pharmaceuticals (M. Pharm) or equivalent.

• Experience:

• 10-15 years of experience in manufacturing, product development, and technology transfer.
• Proven ability to lead and manage a team of approximately 10 members.

• Skills:

• Deep knowledge of GMP, process validation, and regulatory standards.
• Strong leadership abilities and a proactive approach to process optimization.