Johnson & Johnson Careers :-- Manager- Stability and Investigation Expert Locations: Greater Mumbai, Maharashtra R&D Start a new job search Apply ONLINE

Job Description

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

APPLY:- https://jobs.jnj.com/jobs/1600078639W/Manager-+Stability+and+Investigation+Expert

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.

 

Key Interaction Areas: Extensive interactions with multidisciplinary and multi- site groups which primary include external strategic partners/ material owners, etc.

Quality & Compliance Responsibilities: Ensures quality and compliance following the GMP/ safety requirements and maintain related to assigned activities.

Qualifications

Education & Certifications: MS Degree in Organic Chemistry, Pharmacy, or equivalent life sciences degree. Ph.D. is preferred.

 

Experience: At least 12 years in reputed pharmaceutical company (in Analytical function with proven scientific skills)

 

Functional competencies (Skills, Knowledge and Attributes):

• You hold a PhD degree in Organic chemistry or Pharmaceutical Sciences, or equivalent through experience.
• Good knowledge and experience analytical techniques required for drug substances and drug product characterization (LC, MS, dissolution, DSC, DVS, XRPD…)
• Knowledge of ASAP and DoE would be an asset
• Practical experience in pharmaceutical Industry in one or more of the above listed test parameters and GMP regulation is an asset.
• Ensure high scientific quality standards for experiments and ownership of work
• Efficient, flexible and dynamic
• Innovative solutions/problem solving skills
• You have project management experience 
• You are customer-oriented and results-driven
• You have good knowledge of the English language, both spoken and written
• You have good technical writing skills
• You are able to work independently and are also a team player
• Embrace competencies needed to work in diverse teams and to ensure inclusion
• Knowledge of the quality systems like events, deviation, OOS/OOT, CAPA & change controls etc.

 

Behavioral Competencies (/Leadership Imperatives):

• Good team player having Self-confidence, ethics and values and analytical thinking capability
• Technical and Project management skills, excellent writing and communication skills.
• Ability to foster team productivity and cohesiveness in a complex matrix environment.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.

Primary Location
Asia Pacific-India-Maharashtra-Greater Mumbai
Organization
Johnson & Johnson Private Limited (8080)
Job Function
R&D