Manager- Stability and Investigation Expert @ Johnson & Johnson
Requisition ID: 1600078639W
Johnson & Johnson - Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas.
Job Description:
Job Title (India Specific): Manager- Stability and Investigation Expert
Department: PDMS - Clinical Release & Stability
Job Location: Mumbai
Division: Pharmaceutical
Reporting To: Senior Manager – Analytical Development
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 PDMS CRS AD group at Higi, which is responsible for IND/CTA, NDA stability.
Job Responsibilities:
Design and independently lead stability studies to support product development and investigations (using both ASAP (accelerated) and more traditional ICH approaches)
Use predictive models and apply state-of–the art scientific knowledge to ensure innovative and high quality stability evaluation
Work in a multidisciplinary team of researchers and show willingness to learn/explore innovative techniques and stability approach
Act quickly and provide stability solutions and support projects from early to late development phase as stability expert
Support scientifically projects and act as coach for younger scientists
Apply state-of–the art scientific knowledge to ensure high quality delivery
Follow-up literature in order to create new opportunities and stability approach
Ensure compliance with all relevant regulations, guidance, compendial requirements for stability studies, analytical methods and specifications, GMP and safety
Ability to manage teams and collaborate with excellent understanding of customers’ needs
Responsible to meet 100% on time delivery of assigned project activities.
Align with global stakeholders within PDMS and Janssen supply chain organizations to harmonize best practices and support partners to harmonize the lab processes as per the Janssen requirements.
Technically strong and good understanding of analytical techniques such as chromatography, dissolution, moisture determination, particle size determination, spectroscopy, microbiology etc.
Posts
