Lead Formulation Scientist

Placements24; Cape Town; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Conference attendance

Continuous training

Job summary

Placements24 in Cape Town seeks a Lead Formulation Scientist to head the development of oral solids, liquids, injectables and topicals, ensuring stability, bioavailability and manufacturability across the drug pipeline.

You will mentor a team of scientists, design pre-formulation studies, oversee scale-up from lab to production, and prepare regulatory submissions while staying abreast of ICH guidelines and SAHPRA requirements.

Qualifications

• A Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
• A minimum of 7 years of progressive experience in pharmaceutical formulation development.
• Demonstrated expertise in a wide range of dosage forms and drug delivery technologies.
• Strong understanding of material science, physical chemistry, and solid-state properties of drugs and excipients.
• Proven experience in scale-up and technology transfer of pharmaceutical formulations.
• Excellent knowledge of regulatory requirements for drug product development and submission.
• Exceptional leadership, project management, and interpersonal skills.
• Proficiency in laboratory equipment relevant to formulation development (e.g., mixers, tablet presses, dissolution apparatus).

Responsibilities

• Lead formulation development of various dosage forms including oral solids, liquids, injectables, and topicals.
• Design and execute pre-formulation studies to characterize drug substances and excipients.
• Develop and optimize robust formulations with desired physicochemical properties.
• Conduct stability studies per ICH guidelines and interpret results for development.
• Scale-up formulation processes from lab to pilot and production scales.
• Troubleshoot formulation and manufacturing challenges with effective solutions.
• Collaborate with analytical development, process engineering, and manufacturing teams.
• Prepare development reports, regulatory submissions (IND/NDA), and presentations.
• Mentor and guide junior formulation scientists for technical growth.
• Stay updated with trends in drug delivery and formulation science.
• Ensure compliance with regulatory guidelines and SOPs (FDA/EMA/SAHPRA).

Skills

Leadership

Formulation development

Project management

Analytical skills

Problem-solving

Team mentoring

Regulatory understanding

Education

PhD or MSc in Pharmaceutical Sciences/Pharmaceutics/Chemical Engineering

Tools

Tablet presses

Dissolution apparatus

Mixers

Job description

About the Role

Our client, a prominent player in the pharmaceutical sector, is actively seeking a highly skilled and innovative Lead Formulation Scientist to spearhead their formulation development activities in Cape Town, Western Cape . This leadership role involves overseeing the design, development, and optimization of robust pharmaceutical dosage forms for both novel and existing drug products. The successful candidate will play a critical role in advancing candidates through the drug development pipeline, ensuring product stability, bioavailability, and manufacturability. This position demands a deep understanding of pharmaceutical sciences, excipient functionalities, and various drug delivery systems. You will be instrumental in guiding a team of talented scientists, fostering a culture of scientific excellence and innovation.

Key Responsibilities

• Lead the formulation development of various dosage forms, including oral solids, liquids, injectables, and topicals.
• Design and execute pre-formulation studies to characterize drug substances and excipients.
• Develop and optimize robust formulations ensuring desired physicochemical properties and performance.
• Conduct stability studies according to ICH guidelines and interpret the results to support product development.
• Scale-up formulation processes from laboratory to pilot and commercial manufacturing scales.
• Troubleshoot formulation and manufacturing challenges, implementing effective solutions.
• Collaborate closely with analytical development, process engineering, and manufacturing teams to ensure seamless project progression.
• Prepare comprehensive development reports, regulatory submission documents (e.g., IND, NDA), and presentations.
• Mentor and guide junior formulation scientists, fostering their technical growth and professional development.
• Stay updated with emerging trends and technologies in drug delivery and formulation science.
• Ensure compliance with all relevant regulatory guidelines (e.g., FDA, EMA, SAHPRA) and company SOPs.

Requirements

• A Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, or a related discipline.
• A minimum of 7 years of progressive experience in pharmaceutical formulation development.
• Demonstrated expertise in a wide range of dosage forms and drug delivery technologies.
• Strong understanding of material science, physical chemistry, and solid-state properties of drugs and excipients.
• Proven experience in scale-up and technology transfer of pharmaceutical formulations.
• Excellent knowledge of regulatory requirements for drug product development and submission.
• Exceptional leadership, project management, and interpersonal skills.
• Proficiency in laboratory equipment relevant to formulation development (e.g., mixers, tablet presses, dissolution apparatus).
• Strong analytical and problem-solving abilities.
• Must be eligible to work in South Africa .

Benefits

Our client offers a highly competitive remuneration package, including an attractive base salary, performance bonuses, and comprehensive health insurance and retirement benefits. The company provides ample opportunities for professional growth, including attendance at international conferences and continuous training programs. A stimulating work environment that encourages innovation and collaboration is guaranteed. This role offers significant scope for career advancement within a globally recognized organization.