Senior Scientist 1

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Lead Researcher

Job Summary: Lead Researcher

The Lead Researcher plays a crucial role in the development of pre-formulation, formulation, process, and scale-up efforts for Controlled Release Dosage Forms in Cranbury, NJ. Following cGMP standards and employing a risk-based approach, this position is responsible for planning, executing, and documenting pilot and pivotal batches to ensure scientific integrity and compliance.

Responsibilities:

  • Conduct and manage the development activities for Controlled Release Dosage Forms, ensuring adherence to quality standards, SOPs, and regulations.
  • Prepare technical reports and contribute to regulatory submissions, documenting studies in accordance with Good Documentation Practices.
  • Implement Quality by Design (QbD) principles to identify and control product and process variables.
  • Collaborate with analytical teams to perform physical and chemical characterization, utilizing statistical tools for data analysis.
  • Oversee cGMP manufacturing activities, coordinating with external labs, CROs, and CDMOs.
  • Troubleshoot production issues, update project statuses, and ensure proper maintenance of laboratory and equipment.
  • Assist QA department in CAPA and change controls, authoring regulatory documents for NDA/ANDA submissions.
  • Mentor and provide training to junior scientists, while also updating and creating SOPs as needed.

Requirements:

  • Minimum of 9+ years of experience with a Bachelor’s degree in Pharmaceutical Science or a related field, 7 years of experience with a Master’s degree, or 4 years of experience with a PhD in pharmaceutical formulation and product development.

This role demands a combination of pharmaceutical sciences expertise, strong analytical skills, and effective collaboration across departments to drive efficient advancement of product development projects.

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