Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Post: Manager – SMMD
Job Description
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 Responsibilities:
• Ability to manage teams and collaborate with excellent understanding of customers’ needs.
• Responsible to meet 100% on time delivery of assigned project activities.
• Proven track record in method development and method validation.
• Technical review of project data generated in Analytical Development organization.
• Technical review of project data generated at partners’ sites by interfacing with key stakeholders.
• Responsible for technical review reports and statistical interpretation of analytical data.
• Understanding of the current GMP requirements and different regulatory requirements related to regulatory guidelines for filing.
• Interact with Project leads and scientific integrators as per the need to resolve analytical issues.
• Good understanding of Quality systems and ability to work in a matrix environment.
• Interact with global document management groups to identify process gaps and implement solutions.
• Align with global stakeholders within PDMS and JSC organizations to harmonize best practices and support partners to harmonize the lab processes as per the Janssen requirements.
• Prior experience in regulatory filing of reports to various regulatory authorities and responding to queries.
• Technically strong and good understanding of analytical techniques such as chromatography, dissolution, moisture determination, particle size determination, spectroscopy, microbiology etc.
Candidate Profile
Qualification, Education & Experience:
• Minimum Master or Ph.D degree in Chemistry, Pharmacy, or equivalent. • At least 10 years of experience in reputed pharmaceutical company.
• Prior experience of leading team of Analysts.
• Prior Quality assurance and regulatory exposure is plus.
• General knowledge of the pharmaceutical drug development process.
• Demonstrated knowledge of analytical or biochemistry in an R&D environment.
• Demonstrated project management and leadership experience.
• Knowledge of ICH guidelines and pharmacopeia requirements.
• Knowledge of method development, Method validation and Method transfer requirements and good understanding of statistical tools applied in analytical chemistry.
• Good communication and writing skills.
• Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures and dynamics.
• Embrace competencies needed to work in diverse teams and to ensure inclusion.
• Flexibility and commitment to target delivery.
Additional Information:
Experience: 10 years
Qualification: Ph.D
Location: Maharashtra-Greater Mumbai
Functional Area: R&D
Industry Type: Pharma/Biotech/Clinical Research
Requisition ID: 1600078651W
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