Head of Formulation & Process Development

Placements24; Gqeberha; On-site; ZAR 1,200,000 - 2,000,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision coverage

Retirement plan with employer matching

Paid time off

Professional development opportunities

Job summary

Placements24 is seeking a Lead Pharmaceutical Development Scientist for a Port Elizabeth facility to lead formulation development, process optimization, and scale-up for both small molecules and biologics. You will mentor a team, ensure GMP compliance, and drive technology transfer to internal sites or CMOs.

You will collaborate with analytical development, QA, regulatory affairs, and manufacturing teams to ensure project success and regulatory readiness, supporting IND/NDA activities as needed.

Qualifications

• Masters or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry or related field.
• Minimum 8 years of progressive experience in pharmaceutical product development, focusing on formulation and process development.
• Proven track record of developing and launching pharmaceutical products.
• In-depth knowledge of drug delivery systems, dosage form design, and manufacturing technologies.
• Strong understanding of cGMP, ICH guidelines, and regulatory submission requirements.
• Excellent leadership, project management, and team collaboration skills.

Responsibilities

• Lead and manage all aspects of pharmaceutical formulation and process development for assigned projects.
• Design and execute studies for drug product characterization, stability, and performance evaluation.
• Develop and optimize manufacturing processes, ensuring scalability, robustness, and GMP compliance.
• Oversee technology transfer activities to internal manufacturing sites or CMOs.
• Provide technical guidance and mentorship to a team of scientists and technicians.
• Collaborate with analytical development, quality control, regulatory affairs, and manufacturing teams to ensure project success.
• Prepare and review technical reports, development summaries, and sections of regulatory submissions (e.g., IND, NDA).
• Troubleshoot and resolve technical challenges encountered during development and manufacturing.

Skills

Leadership

Project management

Team collaboration

DoE (Design of Experiments)

Statistical analysis

Analytical thinking

Problem solving

Small molecules & biologics experience

Education

Master's or PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry or related field

Job description

Placements24 is seeking a Lead Pharmaceutical Development Scientist for a Port Elizabeth facility to lead formulation development, process optimization, and scale-up for both small molecules and biologics. You will mentor a team, ensure GMP compliance, and drive technology transfer to internal sites or CMOs.

You will collaborate with analytical development, QA, regulatory affairs, and manufacturing teams to ensure project success and regulatory readiness, supporting IND/NDA activities as needed.