Manager - Analytical Development (Analytics)

8080-Johnson & Johnson Private Limited Legal Entity; Mumbai; On-site; INR 4,000,000 - 9,000,000; Full time

Job summary

Johnson & Johnson in Mumbai is seeking a Manager-Analytics (DPDS, Synthetics) to lead analytical development for synthetic drug products, spanning from development through launch in global markets.

The role requires strong scientific leadership, oversight of method development and validation, and collaboration across Regulatory, QA, and Manufacturing to deliver high-quality analytical solutions while maintaining GMP compliance.

Qualifications

• Bachelor’s/Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry or Pharmacy.
• Ph.D. in Analytical Chemistry or related field is preferred.
• Experience in pharmaceutical analytical development and regulatory expectations is desirable.

Responsibilities

• Lead analytical development activities for synthetic drug products from development through commercialization.
• Provide oversight for method development, validation, transfer and lifecycle management.
• Drive quality data generation and documentation supporting global regulatory submissions.
• Review and approve analytical protocols, reports, specifications and validation documents.
• Provide leadership during investigations, root-cause analysis and corrective actions.
• Drive adoption of innovative analytical technologies and digital tools; ensure compliance with GMP and data integrity.

Education

Bachelor’s/Master’s in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Pharmacy, or related discipline

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline

Tools

Mass spectrometry

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Discovery & Pre-Clinical/Clinical Development

Job Sub Function: Pharmaceutical Product R&D

Job Category: People Leader

All Job Posting Locations: Mumbai, Maharashtra, India

Job Description

Company Overview:

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products, and services to life to advance the health and well‑being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments. 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 wellbeing. 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 approaches 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 This strategic planning and execution.

Leadership Requirements:

The ideal candidate should demonstrate: Proven leadership experience managing scientific teams Strong coaching, mentoring and development skills Ability to lead through organization change. Subtle emotional intelligence High collaborative Excellence verbal 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

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com/.

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