Associate Scientist III

ClinLab Solutions Group; Pennsylvania; Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

ClinLab Solutions Group is seeking an Associate Scientist III to support pharmaceutical product development, including preparation, testing, and analysis of products in compliance with regulatory and quality standards.

This role supports R&D and operations during technology transfer, scale-up, and process development, and contributes to the design and improvement of new and existing formulations. It requires collaboration with cross-functional teams and meticulous documentation.

Qualifications

• Master's degree in Pharmaceutical/Medical Sciences/Chemistry or equivalent (0–4 years) or PhD with related focus.
• PhD in pharmaceutical/biomedical sciences with up to 2 years' relevant experience.
• Strong proficiency in cGMP, 21 CFR Part 211, QbD, PAT, ICH, ISO standards.
• Proficient in chemical analytical techniques and data analysis.
• Excellent English communication and collaboration skills.
• Ability to learn quickly and work independently with limited supervision.

Responsabilités

• Assist in preparation, testing, and analysis of pharmaceutical products per regulatory standards.
• Support technology transfer, scale-up, and process development including validation batches.
• Lead and participate in design and development of new products and formulations.
• Manage equipment calibration, chemical inventory, and lab experiments safely.
• Develop and optimize formulations, select raw materials, evaluate processes and specs.
• Address issues related to lab development, scale-up, validation, regulatory and commercial aspects.
• Prepare physical testing, dissolution, and permeation studies; develop evaluation methods.
• Maintain lab records; author and review SOPs; ensure training and safety compliance.

Connaissances

Analytical skills

Data analysis

Lab techniques

Scientific writing

English communication

Independent work

Formation

Master's degree in Pharmaceutical/Medical Sciences/Chemistry

PhD in pharmaceutical/biomedical sciences

Outils

Microsoft Office

Oracle ERP

Description du poste

Summary:

Seeking an Associate Scientist III to support pharmaceutical product development, including preparation, testing, and analysis of products in compliance with regulatory and quality standards. This role involves supporting R&D and operations during technology transfer, scale-up, and process development, as well as contributing to the design and improvement of new and existing products.

Responsibilities:

• Assist in the preparation, testing, and analysis of pharmaceutical products, ensuring compliance with regulatory and quality standards.
• Support technology transfer, scale-up, and process development activities, including manufacturing of validation and clinical batches.
• Lead and participate in the design and development of new products and improvements to existing formulations.
• Manage equipment calibration, chemical inventory, and laboratory experiments, ensuring a safe and organized lab environment.
• Develop and optimize unique formulations, select raw materials, and evaluate manufacturing processes and product specifications.
• Anticipate and address potential issues related to lab development, scale-up, validation, clinical, regulatory, and commercial aspects.
• Prepare and execute physical testing, dissolution, and permeation studies, and develop methodologies for evaluating dosage forms.
• Maintain accurate lab records, author and review SOPs, write project reports, and ensure compliance with all training and safety requirements.

Qualifications:

• Masters degree in Pharmaceutical/Medical Sciences/Chemistry or equivalent with 0-4 years' experience in pharmaceutical product development, OR Ph.D. in pharmaceutical/biomedical sciences with 0-2 years' experience focused on transdermal, topical, oral, or buccal delivery systems.
• Technical understanding of processing equipment for mixing, coating, packaging, and lyophilization preferred.
• Ability to learn quickly and work independently with limited supervision.
• Experience with manufacturing equipment and processes, especially mixing and coating.
• Familiarity with cGMP, 21CFR Part 211, QbD, PAT, ICH, and ISO standards.
• Proficiency in chemical analytical techniques and data analysis.
• Excellent communication skills in English and strong interpersonal abilities.
• Ability to maintain confidentiality and function effectively with standard computer software (Microsoft Office, internet/database searching, email, Oracle ERP systems).