
Senior Formulations Specialist
1 day ago
Product Development Manager Position
The Product Development Manager is accountable for developing novel products and refining existing formulations, including Solid and Liquid Dosage forms. The scope includes regulated markets such as the US, Europe, and Rest of the World.
Main Responsibilities:
- Define project parameters, establish activity timelines, and ensure timely completion.
- Lead on formulating new products by investigating API attributes, viability, safety, and compatibility with other ingredients.
- Determine resource requirements for projects, assimilate literature data, and guarantee appropriate usage throughout development.
- Create R&D plans and experimental designs applying QBD principles for new product development projects and processes.
- Plan and coordinate lab scale-up/optimization and pilot BE batches ensuring adherence to laboratory GMP practices.
- Review lab experiment notebooks, prepare technology transfer documents, and collaborate with production teams.
- Optimize existing product performance by researching API characteristics and finished products.
- Evaluate stability protocols, monitor stability studies, and interpret results to advance product development activities.
- Collaborate with various departments, develop SOPs, manuals, and guidelines, and oversee IQ/OQ/PQ activities.
- Ensure proper storage and disposal of raw materials and finished goods, and participate in departmental audits.
Required Skills & Qualifications:
- Masters degree in pharmacy (Pharmaceutics)
- Formulation development experience of Solid & Liquid Oral; preferred Pellets project experience.
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