PHARMA: J&J IM, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time 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, J&J IM India brings innovative products, services and solutions to people throughout the world. J&J IM 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.
Division: Johnson and Johnson, Innovative Medicine
Job Function: Discovery, Product Development and Supply-Analytical Development (Analytics)
Job Sub-function: Pharmaceutical Product R&D
Job Category: Scientific/Technology.
We are searching for Manager-Analytics, DPDS-Synthetics based at our R&D facility in Mumbai, India.
Role Purpose
We are seeking Manager, Analytical Development (Analytics) – DPDS, Synthetics to lead a team of scientists responsible for Analytical Development activities supporting Synthetic drug products throughout the product lifecycle for launch in Global markets.
This position is a critical people leadership role responsible for delivering high-quality analytical solutions that support CMC and new product development teams, regulatory submissions, technology transfers, and lifecycle management initiatives.
The successful candidate will provide scientific leadership, strategic direction, and operational oversight while fostering a culture of innovation, compliance, collaboration, and talent development. The role requires strong expertise in pharmaceutical analytical development, regulatory expectations, and project execution within a Global matrix environment.
Key Responsibilities
Scientific & Technical Leadership
Lead analytical development activities for Synthetic drug products and new modality programs from development through commercialization.
Provide scientific oversight for analytical method development, validation, transfer, method robustness assessments and technical troubleshooting activities.
Actively participate in stability strategy development and support stability studies across development phases.
Ensure generation of high-quality analytical data and technical documentation supporting Global regulatory submissions.
Review and approve analytical protocols, reports, specifications, validation documents, and technical assessments.
Provide scientific leadership during investigations, root cause analysis, risk assessments, and implementation of corrective actions.
Drive implementation of innovative analytical technologies, digital tools, and industry best practices.
Support health authority inspections and responses to regulatory agency queries.
Project Management
Lead planning, prioritization, and execution of project deliverables within internal teams across multiple development programs.
Collaborate with Pharmaceutical Development, Regulatory Affairs, Quality, Manufacturing labs, and external partners to ensure project success.
Monitor project timelines, resource utilization, risks, and mitigation plans to ensure on-time delivery.
Support strategic portfolio planning and capacity management activities.
Drive continuous improvement initiatives that enhance efficiency, quality, and compliance.
People Leadership
Lead, coach, and develop a team of scientists.
Establish a high-performance culture focused on accountability, ownership, scientific excellence, and collaboration.
Conduct talent management activities such as performance and development planning, succession planning, and career development activities.
Identify capability gaps and implement development plans to build future organizational capabilities.
Foster an inclusive work environment that promotes innovation, engagement, and employee well-being.
Ensure effective onboarding, mentoring, and technical training of team members.
Role model company values and leadership expectations.
Quality, Compliance & Operational Excellence
Ensure compliance with GMP, data integrity, safety, and company quality requirements.
Maintain inspection readiness and participate in internal and regulatory audits leading discussions for the given scope of work.
Ensure adherence to EHS policies and procedures.
Manage departmental resources, and laboratory operational excellence initiatives.
Promote continuous improvement through application of digital and process excellence principles.
Scientific Requirements / Technical Skills
The successful candidate should demonstrate
Core Analytical Expertise
Strong knowledge of Pharmaceutical analytical development for synthetic compounds and drug products.
Extensive experience in analytical method development, validation, transfer, verification, and lifecycle management.
Experience supporting stability studies and development programs across clinical and commercial phases.
Strong understanding of analytical techniques such as, but not limited to, chromatography, dissolution, spectroscopy, solid state characterization, impurity profiling techniques, MS expertise (preferred)
CMC & Regulatory Expertise
Strong understanding of CMC development requirements.
Deep knowledge of ICH guidelines, pharmacopoeia requirements, and current Global regulatory expectations.
Experience supporting NDA/MAA/ANDA submissions and health authority interactions.
Knowledge of quality systems, GMP, data integrity, and laboratory compliance requirements.
Business & Project Skills
Project management and resource planning.
Risk assessment and problem-solving.
Cross-functional stakeholder management.
Strategic planning and execution.
Leadership Requirements
The ideal candidate should demonstrate
Proven leadership experience managing scientific teams
Strong coaching, mentoring, and talent development capabilities
Ability to lead through organizational change and ambiguity
High level of emotional intelligence and influencing skills
Strong collaboration and stakeholder management capabilities
Excellent verbal, written, and presentation skills
Ability to drive accountability, engagement, and performance
Strategic mindset with strong execution focus
Demonstrated ability to build inclusive, diverse, and high-performing teams.
Minimum Qualifications
Education
Bachelor’s/Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Pharmacy, or related discipline with significant industry experience
Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
Experience
Minimum 12 to 15+ years of Pharmaceutical Analytical Development experience
Minimum 5 years of leadership experience managing scientific teams.
Experience supporting Global pharmaceutical development programs.
Experience with regulatory inspections and health authority interactions.
Experience leading cross-functional development projects in a Global environment.
Success Profile
The ideal candidate is a scientifically strong leader who combines deep analytical development expertise with a passion for developing people, driving innovation, ensuring compliance, and delivering high-quality outcomes that support patients and product success across the development lifecycle.
Location: India (Mumbai)
Function: DPDS Synthetics / Analytical Development
Reporting Level: People Manager
Direct Reports: Scientists and/or Senior Scientists
Reporting To: Director-Analytics
Required Skills
Preferred Skills
Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Data Governance, Developing Others, Drug Discovery Development, Good Governance, Inclusive Leadership, Industry Analysis, Interdisciplinary Work, Leadership, Market Research, Process Improvements, Product Development, Product Strategies, Scientific Research, Stakeholder Engagement, Team Management
