Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products. J&J Consumer Business is the sixth-largest consumer health care business in the world, containing a broad portfolio of iconic Consumer and OTC brands that are based on sound science and technology.As per J&J Global Consumer Strategy, our energy and resources need to get focused towards “Winning in 5 Chosen Need States” in the Asia-Pacific markets. One of these 5 strongholds is to “Accelerate OTC growth”. India is a strategic “Invest to Grow” market for J&J, among Top 5 growth priorities for Consumer sector, and a key contributor to AP Region’s Growth.
Post: Executive R&D
Overview
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
Responsibilities :
- Analytical Method Development and Validation mainly Assay, RS, CU, water content by Karl Fisher, pXRD 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
Qualifications
Masters in Science or Pharmaceuticals (in Analytical Chemistry or equivalent from reputed University)
At least 8 years of industrial experience in reputed pharmaceutical company
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Functional competencies (Skills, Knowledge and Attributes):
- 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 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.
Behavioral Competencies (/Leadership Imperatives):
Analytical thinking
Good team player
Result Orientation
Ethics and values
Communication skills (able to write and speak English fluently)
Additional Information:
Experience: 8Years
Qualification: M.Sc/M.Pharm
Location: Mumbai
Industry Type: PDMS-SMMD-AD
Functional Area: R&D
Last date:10th Sept, 2016
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