Apotex Formulation Development Scientist Position – Pharma Apply Online
Job Title: Formulation Development – Research Scientist
Location: Bangalore, KA, IN, 560100
Date Posted: November 26, 2024
Company: Apotex
About Apotex
Apotex Inc. is a Canadian-based global health company delivering high-quality, affordable medicines across over 75 countries. With nearly 7,200 employees worldwide, Apotex specializes in the development and sale of generic, biosimilar, and specialty products, supporting its vision of accessible healthcare solutions.
For more information, visit: www.apotex.com
Job Summary
The Scientist-Formulation Development leads the development of solid oral dosage forms for Apotex’s product pipeline. This role involves experimental design, analysis of scientific data, and collaboration with cross-functional teams to resolve complex product development issues. The position requires adherence to cGMP standards, regulatory compliance, and effective problem-solving skills.
Key Responsibilities
Formulation Development
- Design and develop formulations for products under development.
- Conduct patent searches and review scientific literature for strategic insights.
- Apply Quality-by-Design (QbD) principles to product development, optimizing control strategies for Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs).
- Evaluate data on trials (e.g., dissolution, assay, content uniformity) to make informed decisions on bio/stability study batches.
Operational Coordination
- Ensure availability of APIs, excipients, tooling, and other materials.
- Collaborate with plant operation supervisors to execute experimental trials and registration batches.
- Coordinate with labs for sample testing and provide timelines for analysis.
- Oversee documentation preparation for early development, scale-up, and regulatory submissions.
Regulatory and Compliance
- Respond to regulatory agency queries in a timely manner.
- Prepare Pharmaceutical Development Reports and documents for submissions and technology transfers.
- Adhere to GMP, GLP, GDP, FDA, and other regulatory guidelines.
Technical Expertise
- Investigate formulation and process issues using advanced techniques to identify root causes and corrective actions.
- Maintain knowledge of solid oral dosage forms (immediate release, controlled release, delayed release) and excipient properties.
- Provide technical consultation within the Formulation Development department and across the company.
Requirements
Education
- Master’s degree or Ph.D. in Pharmacy, Pharmaceutical Technology, or related sciences.
Experience
- 3-6 years of experience in formulation development of solid oral dosage forms for regulated markets.
- Hands-on experience with scale-up and technology transfer.
Skills
- Proficient in theoretical and practical knowledge of pharmaceutical manufacturing processes and equipment.
- Strong understanding of excipient properties and their role in formulation.
- Advanced Microsoft Office skills (Word, Excel, PowerPoint, Outlook).
- Excellent communication, organizational, and report-writing skills.
- Knowledge of FDA, TPD guidelines, and compliance standards.
- Ability to multi-task and manage projects effectively.
