Principal Formulation Scientist - Injectables

Placements24; Gqeberha; Hybrid; ZAR 1,000,000 - 1,600,000; Full time

Benefits offered by this job

Private medical aid

Retirement plan

Performance-based bonuses

Relocation assistance

Professional development opportunities

Collaborative culture

Job summary

Placements24 is seeking a Principal Formulation Scientist for its Port Elizabeth R&D team to design, develop, and optimize sterile injectable formulations, including solutions, suspensions, and liposomal systems.

The role requires a PhD or Masters in Pharmaceutical Sciences, 7–10 years in sterile formulation development, expertise in parenteral delivery, aseptic processing, analytical methods, and strong writing and leadership skills.

Qualifications

• PhD or Master's in Pharmaceutical Sciences or related field.
• 7–10 years hands-on formulation development experience, sterile injectables.
• Strong knowledge of parenteral drug delivery systems and aseptic processing.
• Experience with HPLC, GC, particle size analysis, rheology.
• Familiarity with FDA/EMA regulatory requirements for injectables.

Responsibilities

• Lead formulation development of sterile injectable products from concept to development.
• Design pre-formulation studies, solubility, and compatibility assessments.
• Develop scalable formulation processes meeting specs and regulatory standards.
• Perform stability studies per ICH guidelines and interpret results.
• Collaborate with analytical development, manufacturing, and regulatory teams.

Skills

Analytical techniques

Sterile injectables

Project leadership

Pharmaceutical writing

Regulatory knowledge

Problem solving

Experimental design

Education

PhD in Pharmaceutical Sciences

Master's in Pharmaceutical Sciences or related field

Tools

ICH guidelines

Job description

About the Role

Our client, a progressive pharmaceutical company specializing in sterile injectables, is seeking a highly skilled Principal Formulation Scientist to join their Research & Development team in Port Elizabeth. This senior position will play a pivotal role in the design, development, and optimization of complex injectable formulations, including sterile solutions, suspensions, and liposomal drug delivery systems. You will leverage your deep expertise in pharmaceutical sciences to drive projects from concept through to pre-formulation and formulation development, ensuring product quality, stability, and efficacy. This is an exceptional opportunity to contribute to innovative product development within a rapidly growing company. The successful candidate will work in a state-of-the-art facility, collaborating with a multidisciplinary team. The role is based in the vibrant coastal city of Port Elizabeth, Eastern Cape.

Key Responsibilities

• Lead the formulation development of sterile injectable products, including parenteral solutions, suspensions, and complex delivery systems.
• Design and conduct pre-formulation studies, solubility assessments, and compatibility studies.
• Develop robust and scalable formulation processes that meet product specifications and regulatory requirements.
• Perform stability studies according to ICH guidelines to assess product shelf-life and degradation pathways.
• Investigate and resolve formulation-related issues during development and scale-up.
• Collaborate closely with analytical development, manufacturing, and regulatory affairs teams.
• Develop and validate analytical methods for characterization of drug substances and formulated products.
• Prepare comprehensive technical reports, formulation development summaries, and regulatory submission documents.
• Mentor junior scientists and contribute to the scientific advancement of the formulation development group.
• Stay current with the latest advancements in injectable drug delivery technologies and pharmaceutical formulation science.

Requirements

• Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
• A minimum of 7-10 years of hands‑on experience in pharmaceutical formulation development, with a strong focus on sterile injectables.
• Extensive knowledge of parenteral drug delivery systems, including solutions, suspensions, emulsions, and liposomes.
• Experience with aseptic processing techniques and sterile manufacturing principles.
• Proficiency in analytical techniques commonly used for characterization of injectable formulations (e.g., HPLC, GC, particle size analysis, rheology).
• Understanding of ICH stability guidelines and experience in designing and executing stability studies.
• Familiarity with regulatory requirements for injectable products (e.g., FDA, EMA).
• Excellent problem‑solving, critical thinking, and experimental design skills.
• Strong scientific writing and communication abilities.
• Proven ability to work independently and lead projects within a team environment.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including private medical aid, a retirement savings plan, and performance-based bonuses.
• Opportunities for continuous learning and professional development are actively supported, including access to industry conferences and specialized training.
• The company culture is collaborative and innovative, prioritizing employee well‑being and work‑life balance.
• Relocation assistance may be provided for qualified candidates.
• Join a dedicated team making significant contributions to advanced drug delivery solutions in Port Elizabeth.