GL Staffing is currently seeking for a Product Development Scientist II will be responsible for the formulation, process development, and scale-up of FDA-regulated liquid and semi-solid prescription drug products. This role involves the development and documentation of data to support product development, scale-up, site qualification, and manufacturing.

Salary: 70k a year

Requirements Include: Product Development Scientist II

• Demonstrated understanding of semi-solid and liquid formulations, chemistry, manufacturing processes, analytical testing, packaging, and product preservation.
• Knowledge of GMPs, FDA/BOP guidelines, ICH standards, and industry best practices.
• Proficient in the development of pharmaceutical dosage forms for commercial manufacturing.
• Ability to work independently with minimal supervision.
• Strong negotiation skills and the ability to influence and persuade diplomatically.
• Proficiency in Microsoft Office Suite (Excel, Word, Teams, and Outlook).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and document data supporting the scale-up, site qualification, manufacturing, testing, and distribution of prescription drug products in compliance with cGMP requirements.
• Prepare and maintain accurate records in lab notebooks and batch records, collaborating with team members to analyze data, identify trends, and perform statistical analyses.
• Create Protocols, Standard Operating Procedures, Study Designs, and Summary Reports with minimal supervision, leading product research initiatives within the R&D team.
• Participate in Change Control processes to evaluate and implement changes for new and existing products.
• Manage project activities and timelines to meet team objectives, communicating effectively with cross-functional groups.
• Supervise R&D batches, scale-up studies, and lab trial compounding activities.
• Design studies to evaluate and select raw materials (APIs, excipients) and packaging components.
• Execute formulation and manufacturing activities, driving process improvement initiatives.
• Contribute innovative ideas for new equipment and processes, participating in the evaluation and introduction of new technologies.
• Support product costing efforts for new products, provide customer quotes, and evaluate new opportunities.
• Assist with troubleshooting, process improvement, cost reduction, and sourcing of alternate materials/vendors in manufacturing operations.

EDUCATION AND EXPERIENCE REQUIRED: Product Development Scientist II

• An advanced degree (MS or Ph.D.) in Chemistry, Pharmacy, Industrial Pharmacy, Engineering, or a related discipline, with at least two years of relevant product or process development experience in the pharmaceutical industry, preferably in semi-solid and/or liquid dosage forms; or
• A Bachelor’s degree in Chemistry, Pharmacy, Industrial Pharmacy, Engineering, or a related discipline with four or more years of relevant work experience.

APPLY NOW! Product Development Scientist II