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Scientific Director, Ad, Tds-Synthetics Apply Now Save Share Job

10+ years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: Master’s Degree/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.