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Post : General AD Manager
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.
- 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.
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Candidate Profile
Education & Certifications: PhD Degree in Analytical Chemistry, Pharmacy, or equivalent life sciences.
Experience: At least 15 years of experience. Leading clinical release and stability groups with MNC or leading Indian Pharma R&D. Should have managed large teams in his/her current or previous role in a global environment (preferably)
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
Additional Information:
Experience: 15 years
Qualification: Ph.D
Location: Maharashtra
Functional Area: PDMS – Clinical Release & Stability
Industry Type: Pharma/Biotech/Clinical Research
End Date: 20th July, 2017
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