Lead Pharmaceutical Formulation Scientist

Placements24; Durban; On-site; ZAR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

Competitive compensation

Medical benefits and retirement plans

Relocation assistance

Job summary

Placements24 is seeking a Lead Pharmaceutical Formulation Scientist for its Durban facility. This senior role leads a team to design, develop, and optimize diverse dosage forms and drug delivery systems, from pre-formulation to commercialization.

You will guide cross-functional teams, ensure cGMP compliance, and manage timelines and budgets while advancing innovative formulations and regulatory submissions in the South African context.

Qualifications

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• 8–10 years in pharmaceutical formulation development with at least 3 years in a leadership or supervisory role.
• Extensive knowledge of dosage forms and drug delivery systems.
• Proven experience in pre-formulation, formulation design, process development, and scale-up.
• Proficiency in analytical techniques (HPLC, dissolution testing, particle size analysis) and solid-state characterization.
• Strong understanding of regulatory requirements (FDA, EMA, SAHPRA) for drug product development.

Responsibilities

• Lead and mentor a team of formulation scientists, fostering a collaborative R&D environment.
• Design, develop, and optimize novel pharmaceutical formulations for small molecules and biologics.
• Oversee pre-formulation studies, including solubility, stability, and excipient compatibility.
• Develop and validate analytical methods for product characterization.
• Plan and execute formulation development studies including pilot-scale manufacturing and tech transfer.
• Ensure compliance with cGMP and regulatory guidelines; collaborate across cross-functional teams.
• Prepare and review technical reports and regulatory submission documents (IND, NDA).
• Stay updated on trends in formulation and drug delivery.

Skills

Leadership

Project management

Communication

Interpersonal skills

Regulatory knowledge

Education

Ph.D. in Pharmaceutics or related

Tools

HPLC

Dissolution testing

Particle size analysis

Solid-state characterization

Job description

About the Role

Our client, a renowned pharmaceutical company, is looking for an exceptional Lead Pharmaceutical Formulation Scientist to spearhead formulation development activities in their state-of-the-art facility in Durban, KwaZulu-Natal. This senior role requires a visionary leader with a proven track record in designing and optimizing drug delivery systems for diverse therapeutic areas. The Lead Scientist will be responsible for guiding a team of scientists, driving innovation in formulation science, and ensuring the successful transition of formulations from early development to commercialization. This is a critical position for someone passionate about shaping the future of pharmaceutical products and leading scientific endeavors within the Durban region.

Key Responsibilities

• Lead and mentor a team of formulation scientists, fostering a collaborative and high-performance research environment.
• Design, develop, and optimize novel pharmaceutical formulations (e.g., oral solids, injectables, topical) for small molecules and biologics.
• Oversee pre-formulation studies, including solubility enhancement, stability assessment, and excipient compatibility.
• Develop and validate analytical methods for characterizing drug products and assessing their performance.
• Plan and execute formulation development studies, including pilot-scale manufacturing and technology transfer to manufacturing sites.
• Ensure all formulation development activities comply with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines.
• Collaborate closely with medicinal chemistry, process development, analytical development, and regulatory affairs teams to achieve project milestones.
• Prepare and review technical reports, development summaries, and regulatory submission documents (e.g., IND, NDA).
• Stay updated on emerging trends and technologies in pharmaceutical formulation and drug delivery.
• Manage project timelines, resources, and budgets effectively for assigned formulation development projects within Durban.

Requirements

• Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or a related field.
• A minimum of 8-10 years of progressive experience in pharmaceutical formulation development, with at least 3 years in a leadership or supervisory role.
• Extensive knowledge of various dosage forms and drug delivery systems.
• Proven experience in pre-formulation, formulation design, process development, and scale-up.
• Proficiency in relevant analytical techniques (e.g., HPLC, dissolution testing, particle size analysis) and solid-state characterization.
• Strong understanding of regulatory requirements (FDA, EMA, SAHPRA) pertaining to drug product development and manufacturing.
• Excellent leadership, communication, and interpersonal skills.
• Demonstrated ability to manage complex projects and cross-functional teams.
• Experience with CMC (Chemistry, Manufacturing, and Controls) sections of regulatory filings.
• Proficiency in pharmaceutical R&D software and statistical analysis tools.

Benefits

• This role offers a highly competitive salary, comprehensive medical and retirement benefits, performance-based bonuses, and significant opportunities for career advancement within a leading pharmaceutical organization based in Durban, KwaZulu-Natal. Our client provides access to cutting-edge technology, a supportive team environment, and the chance to contribute to groundbreaking pharmaceutical innovations. Relocation assistance may be provided for exceptional candidates relocating to Durban.