Lead Process Development Chemist - Pharmaceuticals

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

Benefits offered by this job

Competitive salary

Bonus program

Medical aid

Retirement planning

Professional development

Cape Town location

Work-life balance

On-site amenities

Job summary

Placements24 is seeking a Lead Process Development Chemist in Cape Town to lead API synthesis development, scale-up and tech transfer in a cutting-edge pharmaceutical setting.

The role requires a PhD in Organic/Pharmaceutical Chemistry, 8+ years in process development with at least 2 years in a leadership role, and strong knowledge of cGMP and ICH guidelines. A data-driven, collaborative leader is essential for success.

Qualifications

• PhD in Organic Chemistry, Pharmaceutical Chemistry, or related field.
• 8+ years of progressive pharmaceutical process development experience; at least 2 years in a lead/supervisory role.
• Proven track record in developing and scaling up complex API synthesis routes.
• Strong knowledge of cGMP, ICH guidelines, and regulatory submission processes.
• Experience with PAT and QbD principles is highly desirable.

Responsibilities

• Lead and mentor a team of process chemists and engineers in API development and optimization.
• Design and execute experiments to optimize reaction conditions, purification strategies, and polymorph control.
• Develop scalable, robust manufacturing processes that meet regulatory requirements (cGMP).
• Oversee technology transfer from R&D to pilot plant and commercial manufacturing.
• Troubleshoot process issues during development, scale-up, and manufacturing.
• Author and review development reports, validation protocols, and regulatory filings.
• Collaborate with analytical development, formulation, and manufacturing teams.
• Stay abreast of scientific advancements and industry trends in process development.
• Manage project timelines and resources to meet milestones.
• Ensure safety and environmental compliance in all operations.

Skills

Process development

Leadership

Regulatory knowledge

cGMP

ICH guidelines

PAT

QbD

Technology transfer

Data analysis

Team management

Education

Ph.D. in Organic/Pharmaceutical Chemistry or related field

Job description

About the Role

Our client, a cutting-edge pharmaceutical company, is looking for an accomplished Lead Process Development Chemist to spearhead their drug substance development initiatives in the beautiful city of Cape Town. This is a critical leadership position responsible for guiding the scale-up and optimization of synthetic routes for novel active pharmaceutical ingredients (APIs). The role demands a deep scientific understanding, excellent leadership qualities, and a commitment to advancing pharmaceutical manufacturing. You will be instrumental in translating laboratory discoveries into robust, scalable, and cost-effective manufacturing processes. This is an exceptional opportunity to contribute to life-saving medicines from a world-renowned location in South Africa.

Key Responsibilities

• Lead and mentor a team of process chemists and engineers in the development and optimization of API synthesis routes.
• Design and execute experiments to evaluate and improve reaction conditions, purification strategies, and polymorph control.
• Develop scalable and robust manufacturing processes that meet regulatory requirements (e.g., cGMP).
• Oversee technology transfer activities from R&D to pilot plant and commercial manufacturing.
• Troubleshoot process issues encountered during development, scale-up, and manufacturing.
• Author and review technical documents, including development reports, validation protocols, and regulatory filings.
• Collaborate closely with analytical development, formulation, and manufacturing departments.
• Stay abreast of the latest scientific advancements and industry trends in pharmaceutical process development.
• Manage project timelines and resources effectively to meet development milestones.
• Ensure a strong focus on safety and environmental compliance in all laboratory and pilot plant operations.

Requirements

• Ph.D. in Organic Chemistry, Pharmaceutical Chemistry, or a related field.
• Minimum of 8 years of progressive experience in pharmaceutical process development, with at least 2 years in a lead or supervisory role.
• Proven track record in developing and scaling up complex synthetic routes for APIs.
• In-depth knowledge of cGMP, ICH guidelines, and regulatory submission processes.
• Expertise in various synthetic techniques, catalysis, and purification methods.
• Experience with process analytical technology (PAT) and Quality by Design (QbD) principles is highly desirable.
• Excellent leadership, team management, and communication skills.
• Strong problem-solving abilities and a data-driven approach to development.
• Ability to work effectively in a fast-paced, multidisciplinary environment.
• Located in or willing to relocate to Cape Town.

Benefits

• This role comes with a highly competitive salary and an attractive bonus structure, alongside comprehensive medical aid and retirement planning benefits.
• Our client invests in its employees' growth, offering significant opportunities for professional development, conference attendance, and advanced training.
• Being based in vibrant Cape Town , the position also supports a healthy work-life balance.
• Additional benefits include subsidised on-site amenities and ample scope for career progression within a globally respected pharmaceutical innovator.