Job Description

JOB DESCRIPTION:

Purpose:

Formulation and process development using QbD paradigm to deliver products in a defined timeframe to meet product delivery goals for I&D.

Guide and train team members on use of QbD tools for succesful product and process development.

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.

Trouble shooting 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)

Guide and train team members to effectively use QbD tools for product and process development

Technology transfer and manufacturing of Bio/Clinical batch and process validation batches at in house manufacturing sites and TPMs

Critical Success Factors:

Functional / Technical:

Formulation and Product Development

Follow all the steps to deliver the drug as per QbD paradigm

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.

7-9 yrs

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Product Development

DIVISION: EPD Established Pharma

LOCATION: India
Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 20 % of the Time

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott