Lead Pharmaceutical Process Development Scientist

Placements24; Polokwane; On-site; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Relocation assistance

Professional development support

State-of-the-art facilities exposure

Job summary

Placements24, a leader in the pharmaceutical sector, seeks a visionary Lead Pharmaceutical Process Development Scientist for its Polokwane facility. You will drive design, optimization, and scale-up of manufacturing processes, guiding teams through lab to commercial production, ensuring compliance and quality.

You will lead cross-functional collaborations across engineering, QA, regulatory, and operations, mentor scientists, and contribute to IND/NDA submissions while staying at the forefront of

Qualifications

• Ph.D. or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Minimum of 8 years of hands-on experience in pharmaceutical process development, scale-up, and manufacturing.
• Demonstrated expertise in various pharmaceutical dosage forms (e.g., solid dosage, sterile injectables, biologics).
• In-depth knowledge of cGMP, regulatory requirements (FDA, EMA), and QbD principles.
• Experience with process modeling, simulation, and data analysis tools.
• Strong leadership, project management, and communication skills.
• Ability to work effectively in a fast-paced, team-oriented environment in Polokwane.
• Experience managing direct reports and leading technical projects is essential.

Responsibilities

• Lead the design, development, and optimization of pharmaceutical manufacturing processes for both small molecule and biologic drug products.
• Oversee process scale-up activities from laboratory to pilot and commercial manufacturing scales.
• Develop and implement robust process control strategies and perform process validation studies.
• Utilize process analytical technology (PAT) and statistical process control (SPC) to enhance process understanding and control.
• Troubleshoot complex manufacturing issues and implement effective solutions to maintain product quality and yield.
• Collaborate with cross-functional teams, including engineering, quality assurance, regulatory affairs, and manufacturing operations, to ensure seamless technology transfer and project execution.
• Manage and mentor a team of scientists and engineers, providing technical leadership and fostering a high-performance culture.
• Author and review technical reports, protocols, and regulatory submission documents (e.g., IND, NDA, BLA).
• Stay abreast of emerging technologies and scientific advancements in pharmaceutical process development.

Skills

Process development

Leadership

Regulatory knowledge

Data analysis

Scale-up

Education

PhD or MSc in relevant field

Tools

Process modeling software

Job description

About the Role Our client, a distinguished leader in the pharmaceutical industry, is seeking an experienced and visionary Lead Pharmaceutical Process Development Scientist to spearhead critical initiatives from their **Polokwane** facility. This role is central to optimizing and innovating our client's manufacturing processes, ensuring efficiency, scalability, and compliance with the strictest global standards. The ideal candidate will possess a deep understanding of pharmaceutical manufacturing principles and a proven track record in process development and scale-up. Joining our client means becoming part of a forward-thinking organization committed to advancing healthcare solutions. You will play a key role in shaping the future of pharmaceutical production within the **Limpopo** province, contributing to the development of life-changing medicines. This position is office-based, offering a fully immersive experience in a state-of-the-art research and development environment, fostering intense collaboration and rapid progress.

Key Responsibilities

• Lead the design, development, and optimization of pharmaceutical manufacturing processes for both small molecule and biologic drug products.
• Oversee process scale-up activities from laboratory to pilot and commercial manufacturing scales.
• Develop and implement robust process control strategies and perform process validation studies.
• Utilize process analytical technology (PAT) and statistical process control (SPC) to enhance process understanding and control.
• Troubleshoot complex manufacturing issues and implement effective solutions to maintain product quality and yield.
• Collaborate with cross-functional teams, including engineering, quality assurance, regulatory affairs, and manufacturing operations, to ensure seamless technology transfer and project execution.
• Manage and mentor a team of scientists and engineers, providing technical leadership and fostering a high-performance culture.
• Author and review technical reports, protocols, and regulatory submission documents (e.g., IND, NDA, BLA).
• Stay abreast of emerging technologies and scientific advancements in pharmaceutical process development.

Requirements

• Ph.D. or Master's degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Minimum of 8 years of hands‑on experience in pharmaceutical process development, scale‑up, and manufacturing.
• Demonstrated expertise in various pharmaceutical dosage forms (e.g., solid dosage, sterile injectables, biologics).
• In‑depth knowledge of cGMP, regulatory requirements (FDA, EMA), and QbD principles.
• Experience with process modeling, simulation, and data analysis tools.
• Strong leadership, project management, and communication skills.
• Ability to work effectively in a fast‑paced, team‑oriented environment in **Polokwane**.
• Experience managing direct reports and leading technical projects is essential.

Benefits

• Highly competitive salary and performance-based bonus structure.
• Comprehensive benefits package including medical, dental, and vision insurance.
• Retirement savings plan with company matching.
• Generous allowance for professional development and conference attendance.
• Significant opportunities for career advancement within a growing organization.
• Exposure to innovative drug development programs and state-of-the‑art facilities.
• Relocation assistance may be provided for exceptional candidates.