Lead Bioanalytical Scientist - Pharmaceutical

Placements24; Cape Town; Ibrido; ZAR 1.200.000 - 2.000.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

Retirement fund contributions

Paid conferences

Remote-friendly culture

Descrizione del lavoro

Placements24 in the global pharmaceutical arena seeks a Lead Bioanalytical Scientist to design, develop, and validate bioanalytical assays (LC-MS/MS, ELISA, cell-based) for preclinical and clinical programs in a fully remote role based from Cape Town or anywhere.

You will lead a team of scientists, ensure regulatory compliance with FDA/EMA standards, interpret data, manage CROs, and contribute to regulatory submissions. A PhD or Master's and 7+ years of experience are required.

Competenze

• Ph.D. or Master's degree in Biochemistry, Analytical Chemistry, Pharmacology or related field.
• Minimum 7 years of progressive bioanalytical method development and validation experience.
• Expertise in LC-MS/MS and other bioanalytical techniques; ability to mentor teams.

Mansioni

• Lead development, validation, and transfer of complex bioanalytical assays (LC-MS/MS, ELISA, cell-based).
• Provide scientific and technical leadership to a team of bioanalytical scientists.
• Oversee studies supporting drug discovery and development with timely, high-quality data.
• Interpret data, troubleshoot assays, and implement effective solutions.
• Ensure regulatory compliance with FDA/EMA and internal SOPs.
• Collaborate with cross-functional teams to define bioanalytical strategies.
• Manage external CROs for outsourced bioanalytical activities.
• Contribute to regulatory submissions (IND, NDA).
• Stay abreast of scientific advancements and innovations in bioanalysis.
• Present findings at meetings and conferences.

Conoscenze

Bioanalytical method development

Team leadership

PK/PD knowledge

Regulatory compliance

LC-MS/MS expertise

Project management

Formazione

Ph.D. or Master's degree in Biochemistry, Analytical Chemistry, Pharmacology, or a related field

Descrizione del lavoro

About the Role

Our client, a globally recognized pharmaceutical powerhouse, is seeking an exceptional Lead Bioanalytical Scientist to spearhead critical research initiatives. This is a fully remote position, offering unparalleled flexibility to work from anywhere in Cape Town, Western Cape, ZA , or beyond. You will be responsible for designing, developing, and validating innovative bioanalytical methods to support preclinical and clinical drug development programs. This senior role requires a deep understanding of assay development, pharmacokinetic/pharmacodynamic (PK/PD) principles, and regulatory compliance within the pharmaceutical industry. As a leader, you will guide a team of talented scientists, foster a collaborative research environment, and contribute significantly to the company's pipeline of life‑saving therapies. Your expertise will be vital in advancing compounds from discovery through to market approval, ensuring scientific rigor and data integrity at every step. This is an opportunity to make a profound impact on global health.

Key Responsibilities

• Lead the development, validation, and transfer of complex bioanalytical assays (e.g., LC‑MS/MS, ELISA, cell‑based assays) for small molecules and biologics.
• Provide scientific and technical leadership to a team of bioanalytical scientists, fostering their growth and development.
• Oversee the execution of bioanalytical studies in support of drug discovery and development programs, ensuring timely and high-quality data generation.
• Interpret complex bioanalytical data, troubleshoot assay issues, and implement solutions effectively.
• Ensure all bioanalytical activities comply with relevant regulatory guidelines (e.g., FDA, EMA) and internal SOPs.
• Collaborate closely with cross‑functional teams, including DMPK, clinical pharmacology, and regulatory affairs, to define bioanalytical strategies.
• Manage external CROs for outsourced bioanalytical activities, providing oversight and ensuring data quality.
• Contribute to the preparation of regulatory submission documents (e.g., IND, NDA).
• Stay abreast of the latest scientific advancements and technological innovations in bioanalysis.
• Present research findings at internal meetings and external scientific conferences.

Requirements

• Ph.D. or Master's degree in Biochemistry, Analytical Chemistry, Pharmacology, or a related field.
• Minimum of 7 years of progressive experience in bioanalytical method development and validation within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in multiple bioanalytical techniques, particularly LC‑MS/MS.
• Proven experience in leading and mentoring scientific teams.
• Strong understanding of PK/PD principles and their application in drug development.
• In‑depth knowledge of regulatory requirements for bioanalysis in drug development.
• Excellent analytical, problem‑solving, and organizational skills.
• Superior communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
• Ability to thrive in a fast‑paced, remote work environment.
• This role is fully remote and requires the candidate to be based in or able to work from Cape Town, Western Cape, ZA .

Benefits

• Highly competitive salary package up to R per annum.
• Comprehensive medical, dental, and optical coverage.
• Generous retirement fund contributions.
• Paid annual leave and holidays.
• Support for professional conferences and continuing education.
• Access to state‑of‑the‑art virtual laboratory resources.
• A flexible and empowering remote work culture.
• Performance‑based bonuses and recognition programs.