Formulation Scientist of Technical Manufacturing Operations
2 days ago
This role supports our Technical Operations team by providing product development, reformulation, and process improvement support for various growth, quality, and cost savings projects. The ideal candidate will have experience with production equipment and a strong understanding of cGMP principles.
Key Responsibilities- Support and lead moderately complex formula development, reformulation, and process improvement for various dosage forms.
- Collaborate with PD staff to prepare and execute pilot batches and product scale-up batches, gathering data to support in-process parameters and finished product specifications.
- Perform bench trials, physical evaluations, and collect data to support alternate materials approval processes.
- Direct product development technicians in data collection and processing.
- Provide training to manufacturing associates on new processes and process modifications/improvements.
- Assist in developing new formulations for new active raw materials.
- Work with new equipment to develop studies that improve soft chew manufacturing processes and/or formulations.
- Prepare and approve Master Batch Records and Change Control Requests for all scale-up or production batches.
- Follow applicable cGMP processes.
- Compile and provide summaries of stability data.
- Provide technical support to Manufacturing and Operations teams, monitoring initial production batches for new and reformulated products.
- Stay up-to-date with industry developments by attending expos and conferences and applying knowledge gained.
- Communicate effectively with other departments within the organization and function within a team environment.
- Experience working with soft chew (or similar) dosage forms.
- Excellent interpersonal, communication, and organizational skills.
- Basic ability to define problems, collect data, establish facts, draw valid conclusions, and offer solutions.
- BS/BA in chemistry, food science, life sciences, engineering, or a related discipline, or equivalent experience.
- Must have >5 years of hands-on experience in product development of food, dietary supplements, or related products, including dough, confectionery, or pet treats (animal feed/animal health a plus).
- Experience in a cGMP environment with understanding of cGMP principles and requirements.
- Experience working as part of a cross-functional team.
- Knowledge of animal feed regulations a plus.
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