Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Post: Executive- R&D
Job Description
The Pharmaceutical Development & Manufacturing Sciences Organization (PDMS) of Janssen R&D, constituting of around 1200 people across the globe, aims to develop and bring products to the patients in a timely manner without delays. With a vision of ‘One passionate team transforming molecules to medicines for patients worldwide’ the PDMS Organization covers Active Pharmaceutical Ingredient (API) – Small Molecules, API – Large Molecules, Drug Product Development, Analytical Development, Portfolio Management, Clinical Supply Chain and Strategic Operations.
Small Molecule Method Development (SMMD) is a department of PDMS within the Janssen R&D organization. The department is responsible for the Analytical Method Development/ Validation of assay and related compounds evaluation/ characterization test methods of small molecule drug substance, drug product, intermediates from early development through the lifecycle for commercial products; analytical transfer of these methods to internal and/ or external clinical and commercial testing sites; supporting all regulatory filings (CTA/IND, NDA/MAA, post approval submissions), inspections and investigations. It is also responsible for In-vitro Dissolution Method Development/ Validation and Method Transfer across sites for new as well as marketed products
Responsibility:
- Analytical Method Development and Validation mainly Assay, RS, CU, water content by Karl Fisher, pXRD, DSC, TGA and particle size determination.
- Instrument calibration / qualification activities.
- Performs activities following the GMP/ safety requirements.
- GMP data review, protocol and report preparation for various analytical activities.
For More Information go to Next Page
Subscribe to Pharmatutor Job Alerts by Email
Functional Expertise
· Experience with different types of formulations and API analysis with prior experience in Method Development, Validation and Transfers as per regulatory guidelines.
· Hands on experience in variety of Analytical techniques e.g. HPLC, GC, and UPLC, KFT, pXRD, DSC, TGA and Particle size measurement and their troubleshooting.
· Exposure to empower software for HPLC/UPLC data processing preferred.
· Good analytical data interpretation skills.
· Hands on computer system validation (CSV) system
· Experience of working in a regulated environment is a must.
Candidate Profile
Masters in Science or Pharmaceuticals (in Analytical Chemistry or equivalent from reputed University) At least 8 years of industrial experience in reputed pharmaceutical company
Additional Information:
Experience: 8 years
Qualification: M.Sc. or M.Pharm
Location: Maharashtra-Greater Mumbai
Functional Area: R&D
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th August, 2017
See All Ph.D Alerts M.Pharm Alerts M.Sc Alerts Kolkata Alerts
See All Other Jobs in our Database
.png)
