What are the responsibilities and job description for the Product Development Scientist position at GL Staffing?
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.
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