Career Opportunities in Johnson & Johnson as General AD Manager

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Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.

Post : General AD Manager

Position Summary:
- 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.
- Clinical Release & Stability (CRS) is a department of PDMS within the Janssen R&D organization. The department is responsible for clinical release and stability testing of Drug Substance (DS) and Drug Product (DP) for small molecules covering Phase 1 through Phase 3, DS and DP manufacturing process and product characterization support and the stability process for small and large molecules in R&D.
- This position is in CRS group. The CRS Group is responsible for IND/CTA, NDA stability along with clinical release from Pilot Plant.

 

Job Responsibilities:

  • Responsible for ensuring clinical release and stability activities in India, in support of Global, Asia Pacific, and local Portfolio
  • Technical and scientific lead  for CRS department and technical support for Analytical GMP investigations
  • Responsible to meet 100% on time delivery of assigned project activities irrespective of challenges
  • Oversee lab operations and build global synergies as per the Janssen requirements.
  • Responsible for ensuring 100 % lab operational efficiency and capacity utilization  to ensure seamless delivery
  • Understanding of the current GMP requirements and different regulatory requirements related to Lab operations.
  • Prioritize, innovate and manage knowledge to deliver outstanding operational performance as well as scientific excellence.
  • Ability to translate good understanding of Quality systems to ensure zero internal and external audit failures.
  • Prior Hands on experience in handling all general analytical instruments in the labs.
  • Technically strong and good understanding of analytical techniques such as chromatography, dissolution, Moisture determination, particle size determination, spectroscopy etc.
  • Align with vision and develop strategies to further enhance global analytical development organization.
  • Provide regulatory support to IND. NDA/MAA filings and respond to queries.
  • Ensure process excellence in support to clinical supply chain and apply lean methodologies
  • Facilitate deeper understanding , statistical interpretation of data and elevate scientific rigor at bench level
  • Mentor and train employees at levels in the AD organization.

Functional competencies:
General knowledge of the end to end pharmaceutical drug development process.
Knowledge of ICH guidelines and pharmacopeia requirements and current trends
Understanding of stability method development, Method validation and Method transfer requirements.
Highly technical and ability to focus on science
Proficient in statistical analysis

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