Lead Pharmaceutical Development Scientist

Placements24; Gqeberha; Vor Ort; ZAR 1.200.000 - 2.000.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Medical, dental, vision coverage

Retirement plan with employer matching

Paid time off

Professional development opportunities

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Leadership

Project management

Team collaboration

DoE (Design of Experiments)

Statistical analysis

Analytical thinking

Problem solving

Small molecules & biologics experience

Ausbildung

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

Jobbeschreibung

About the Role

Our client, a dynamic pharmaceutical company, is seeking an accomplished Lead Pharmaceutical Development Scientist to spearhead critical development initiatives at their facility in Port Elizabeth, Eastern Cape. This senior role is central to translating promising drug candidates into safe and effective pharmaceutical products. The successful candidate will lead a team responsible for formulation development, process optimization, and the scale-up of manufacturing processes for both small molecule and biologic drugs. A profound understanding of pharmaceutical sciences, regulatory requirements, and quality assurance is essential. This position offers a unique opportunity to influence product lifecycle management, from early-stage development through to commercialization, within a supportive and innovative environment. If you are passionate about advancing pharmaceutical technology and leading high-impact projects, this role in Port Elizabeth is an excellent fit.

Key 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 compliance with GMP standards.
• Oversee technology transfer activities to internal manufacturing sites or external contract manufacturing organizations (CMOs).
• Provide technical guidance and mentorship to a team of formulation 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 product development and manufacturing.

Requirements

• Master's or Ph.D. degree in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related field.
• Minimum of 8 years of progressive experience in pharmaceutical product development, with a focus on formulation and process development.
• Proven track record of successfully 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.
• Proficiency in statistical analysis and experimental design (DoE).
• Strong analytical and problem-solving abilities.
• Experience with both small molecules and biologics is highly desirable.

Benefits

• We offer a highly competitive salary commensurate with experience, along with an attractive annual bonus structure. Our comprehensive benefits package includes excellent medical, dental, and vision coverage, a generous 401(k) or equivalent retirement plan with employer matching, and substantial paid time off.
• We also provide significant opportunities for professional growth through specialized training, conference participation, and internal advancement programs.
• Employees enjoy access to advanced laboratory facilities and a collaborative culture that encourages innovation.
• This role is based in Port Elizabeth, Eastern Cape, and offers a chance to be part of a company dedicated to improving healthcare worldwide.