Abbott MPharma Associate Job – Apply Online Now
About the Company:
Abbott is a leading pharmaceutical company dedicated to improving people’s lives through innovative healthcare products. We are committed to formulating and developing oral solid and liquid products that meet the highest quality standards. At Abbott, we focus on stability, technology transfer, and successful commercialization of our products in domestic as well as regulated markets.
Research Associate
Location: India – Mumbai
Category: Research & Development
Purpose:
- Formulation Development of oral solid & liquid products with successful stability & technology transfer at the commercial site
Qualification & Experience:
M-pharma, pharmaceutics/M-pharma pharmaceutics with PhD, with a minimum experience of 4-7 years for development of oral solid & liquid products for domestic/ROW/Regulated market.
Core Job Responsibilities:
- Responsible for formulation development (internal and co-development) of new products and CMC remediation products.
- Responsible for process development and successful technology transfer (scale-up and process validation) of formulation / process technologies developed at I&D to different manufacturing locations.
- Use of QbD for Product and process optimization.
- Responsible to identify the risks involved in manufacturing process/ formulation and to mitigate the risk in defined timeframe to meet product delivery goals for I&D.
- Troubleshooting of existing or new products developed at I&D or at different manufacturing locations.
Key Deliverables:
- Literature/Patent search to create drug profile
- Development of stable and robust formulation using QbD tools
- Work with co-development partners for end to end product development (prototype formula till launch)
- Preparation of project documents for filing (stability protocols, PDR, BMR, MMD, and Validation batch etc., for the regulatory filing
- Technology transfer and manufacturing of Bio/Clinical batch and process validation batches at in house manufacturing sites and TPMs
- Formulation Development (From prototype formulation to the scale up batch at R&D center)
- Preparation of project documents for filing (stability protocols, PDR, BMR, MMD, and Validation batch etc., for the regulatory filing
- Follow good documentation practices & maintaining the working labs in compliance.
Critical Success Factors:
Functional / Technical:
- Formulation and Product Development
- Select the suitable polymers / excipients based on scientific rationale
- Evaluation of CQA of drug / excipients and estimate its implications for product development
- Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly
- Design of Experiments
- Executes the experiments as per DOE to optimize product and process, as required
- Pharmaceutical Development Report (PDR)
- Prepares PDR as per Common Technical Document (CTD) module 3 requirements
- Complies with regulatory requirements as defined in QTPP
- Project Management
- Is able to plan and prioritize multiple project deadlines to meet product delivery goals
Education & Experience:
- M. Pharm/Ph. D.
- 4-7 yrs
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