Senior Analytical Development Scientist

Placements24; Noord-Kaap; In loco; ZAR 900.000 - 1.400.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

Retirement plan

Paid time off

Descrizione del lavoro

Placements24 is partnering with a renowned biopharmaceutical company in Kimberley, Northern Cape to hire a Senior Analytical Development Scientist. You will lead method development, validation, and solid‑state characterization, advancing quality across drug substances and products.

The role requires 5+ years in pharma, strong troubleshooting, and experience mentoring junior scientists in a fast-paced R&D setting. GMP compliance and collaboration with multiple teams are essential.

Competenze

• Ph.D. or Master’s in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or related field.
• 5+ years in analytical method development/validation in pharma.
• Hands-on with HPLC, LC-MS, and solid-state characterization.
• Deep knowledge of ICH guidelines and regulatory expectations.
• Strong problem-solving, technical writing, and communication skills.
• Experience leading analytical projects is desirable.

Mansioni

• Develop and validate novel analytical methods for small molecules and biologics (HPLC/LC-MS).
• Characterize drug substances/products, including impurity profiling and stability studies.
• Apply solid‑state techniques (XRPD, DSC, TGA, microscopy) to analytical development.
• Troubleshoot methods/instrumentation to ensure reliable results.
• Transfer methods to QC and CMOs; write development/validation reports.
• Contribute to analytical sections of regulatory submissions (ICH, IND/NDA/MAA).
• Mentor junior scientists and stay updated with guidelines and best practices.

Conoscenze

HPLC

LC-MS

Solid-state characterization

Troubleshooting

Regulatory compliance

Data analysis software

Formazione

Ph.D. or Master's in Analytical Chemistry / Pharmaceutical Sciences / Organic Chemistry

Strumenti

XRPD

DSC

TGA

Microscopy

Descrizione del lavoro

About the Role

Our client, a renowned biopharmaceutical company, is seeking a highly skilled Senior Analytical Development Scientist to join their advanced research and development center in **Kimberley, Northern Cape**. This role is essential for developing, validating, and implementing robust analytical methods for the characterization and quality control of novel drug substances and drug products. You will be instrumental in ensuring the quality, safety, and efficacy of our client's pipeline by applying your expertise in analytical chemistry and solid-state characterization. This is an exciting opportunity to contribute to groundbreaking pharmaceutical research in **Kimberley**, working with cutting‑edge instrumentation and collaborating with a team of dedicated scientists. We are looking for a candidate with a strong scientific foundation, excellent problem‑solving skills, and a passion for analytical sciences within the pharmaceutical industry. The successful applicant will lead key analytical projects and mentor junior team members, driving innovation in analytical methodology.

Key Responsibilities

• Develop and validate novel analytical methods for small molecules and biologics (e.g., HPLC, GC, LC-MS, KF, dissolution).
• Characterize drug substances and drug products, including impurity profiling and stability studies.
• Utilize advanced analytical techniques for solid‑state characterization (e.g., XRPD, DSC, TGA, microscopy).
• Troubleshoot analytical methods and instrumentation, ensuring reliable results.
• Transfer analytical methods to Quality Control (QC) departments and contract manufacturing organizations (CMOs).
• Write method development reports, validation protocols, and validation reports.
• Contribute to the preparation of analytical sections for regulatory submissions (e.g., IND, NDA, MAA).
• Stay current with scientific literature, regulatory guidelines (ICH), and industry best practices in analytical development.
• Collaborate with formulation development, process development, and CMC teams.
• Mentor and guide junior scientists in method development and execution.
• Ensure compliance with GMP and relevant safety regulations in the laboratory.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field.
• Minimum of 5 years of experience in analytical method development and validation within the pharmaceutical industry.
• Strong hands‑on experience with a variety of analytical techniques, particularly HPLC, LC-MS, and solid‑state characterization methods.
• In‑depth knowledge of ICH guidelines and regulatory expectations for analytical development.
• Proven ability to troubleshoot complex analytical problems.
• Excellent written and verbal communication skills, with strong technical writing capabilities.
• Experience with data analysis software and statistical methods.
• Ability to work independently and collaboratively in a fast‑paced R&D environment.
• Experience in leading analytical projects is highly desirable.
• Familiarity with different drug modalities (small molecules, peptides, oligonucleotides) is a plus.

Benefits

Our client offers a competitive salary, comprehensive health, dental, and vision insurance, and an excellent retirement savings plan. Employees benefit from generous paid time off and numerous opportunities for professional growth, training, and attendance at scientific conferences. Our client fosters a stimulating and collaborative research environment in **Kimberley**, prioritizing work‑life balance and employee well‑being. This role provides a unique opportunity to shape the analytical strategies for innovative therapeutics. Further details regarding compensation and specific benefits will be discussed during the interview process.