Perrigo is a leading global healthcare supplier that develops, manufactures, markets and distributes over-the- counter (OTC) products, prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer healthcare products.
Post: Prototype Scientist - Formulation and Development
Job Description
- Knowledge of the principals and practices of pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category.
- Knowledge of current guidelines required
- Sound problem solving skills and good scientific judgment are required.
- Excellent organizational skills, independence, enthusiasm & ability to work in a highly collaborative environment.
- Shall work as a part of multidisciplinary team to ensure product development in a timely & cost effective manner
- Good communication skills and the ability to work on interdisciplinary teams are required. Familiarity with project management methodology is necessary.
Major Duties / Responsibilities
- Provides support to (or may lead)product/process development and scale up activities for new or re-formulation solid oral dosage, liquid oral dosage forms and semisolid topical dosage forms to facilitate “First-to-File” and “First-to-Market” corporate goals with guidance
- Generate and summarise the literature, patent summary using available database, prepare development strategy document with guidance
- Hands-on formulation design including Preformulation studies, development and optimization with Quality by Design concept with guidance as appropriate.
- Design and perform quality scientific experimentation. Contribute to the development of new experimental approaches.
- Design and perform stability studies.
- Generate accurate, reliable data by following established procedures and practices.
- Record, tabulate, summarize, interpret, report and publish study results with guidance
- Prepare Master Batch Records for Experimental, Pilot, scale-up batches with guidance
- Analyze and defend scientific results.
- With guidance, interpret in-vitro and in-vivo data to derive clear conclusions. Prepare or co-author Product Development documents.
- Lead the manufacture of Pilot, Pivotal/Registration lots for new or re-formulation products in the Product/Process Development Pilot Plant and Manufacturing facilities with guidance
- Perform effective problem solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects.
- May lead and/or Collaborates with multidisciplinary teams or stakeholdrs to resolve complex product development issues and respond to internal and external audits with guidance
- Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provides technical support to Technical Operations, Quality and to third party with guiance
- Ensure compliance with current Good Manufacturing Practices (cGMP), Perrigo policies and Quality Systems, and all applicable regulatory agencies.
Additional Information:
Experience: 6-8 years of experience in Formulation and development.
Qualification: Master in Pharmacy
Location: Mumbai, Thane, Ambernath, India
Tracking Code: 2012153
Functional Area: F&D
Last Date: 31st December, 2014
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