Job Title: Scientific Director, AD, TDS-Synthetics
Employer: Johnson & Johnson
Location: Mumbai, India
Date Posted: April 23, 2025
Requisition Number: R-010185
Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Pharmaceutical Product R&D
Job Category: People Leader
Work Pattern: Hybrid Work
Job Description:
At Johnson & Johnson, health is everything. The Scientific Director, AD, TDS-Synthetics will lead a sub-team of the Higi ONE AD organization, responsible for developing and validating chromatographic methods for late-stage synthetic compounds. This role involves method transfers, stability studies, clinical release, and stability testing, supporting NDA/MAA filings. The position requires working in a GMP environment and handling Health Authority inspections.
Key Responsibilities:
Leadership: Lead a sub-team tasked with chromatographic method development and validation for late-stage synthetic compounds.
Project Management: Oversee method validation, transfers, and stability studies. Ensure high-quality outputs, timely results, and regulatory compliance.
Team Development: Identify training needs, coach team members, and support their professional development in method development and stability studies.
Strategic Planning: Develop strategies for the team aligned with organizational goals and ensure compliance with regulatory standards.
Collaboration: Work with other sub-team leaders and external teams to ensure consistency in methodologies and practices for all compounds.
New Modality Programs: Act as the Direct Responsible Individual for new modality programs, including ADCs and peptides.
Stakeholder Interaction: Strengthen interfaces with PQM, IMSC, and other departments, facilitating clear communication and collaboration.
Required Qualifications:
Education: Ph.D. or equivalent by experience with a Master’s degree in a relevant area.
Experience: 10 years of related experience, including at least 5 years of people management experience.
Technical Skills: In-depth knowledge of chromatographic techniques, API and DP development processes, and regulatory guidelines (NDA/MAA filings).
Experience in cGMP: Prior experience in a cGMP environment.
Language: Fluency in English (oral and written).
Preferred Qualifications:
Knowledge of ICH Q2, Q3 (method development and validation), ICH Q1 (stability studies), and strong experience with audits and inspections.
People Management: Experience managing teams of direct and indirect reports.
Supervisory Responsibilities:
Direct Reports: 3-5
Indirect Reports: 22 J&J employees and about 25 non-J&J employees
Benefits:
Competitive salary and benefits.
Hybrid work pattern allowing flexibility.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Digha | Kolkata | Mukundapur |Alabama :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Amsterdam |Netherlands :
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Breda |South Holland :
Leiden |North Yorkshire :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
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Sarajevo |Sofia City :
Sofia |Canada :
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Bucharest |Makkah :
Rabigh | King Abdullah Economic City | Khulais | Riyadh | Jeddah | Najran |Nišava District :
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Taipei |Williamson :
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