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Johnson & Johnson

Makes prescription drugs and medical devices

Manager – Analytical Development - Analytics

Bioprocess & BiomanufacturingUpdated on Nov 12
Full-timeMumbai, Maharashtra, IndiaNo salary listed

About the Job

Requirements

  • 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 including chromatography, dissolution, spectroscopy, solid state characterization, and impurity profiling; mass spectrometry expertise is preferred.
  • Strong understanding of chemistry, manufacturing, and controls (CMC) development requirements.
  • Deep knowledge of International Council for Harmonisation (ICH) guidelines, pharmacopoeia requirements, and current global regulatory expectations.
  • Experience supporting new drug application (NDA), marketing authorization application (MAA), and abbreviated new drug application (ANDA) submissions and health authority interactions.
  • Knowledge of quality systems, good manufacturing practices (GMP), data integrity, and laboratory compliance requirements.
  • Project management and resource planning skills.
  • Risk assessment and problem-solving skills.
  • Cross-functional stakeholder management capabilities.
  • Strategic planning and execution skills.
  • Proven leadership experience managing scientific teams.
  • Strong coaching, mentoring, and talent development capabilities.
  • Ability to lead through organizational change and ambiguity.
  • Strong collaboration and stakeholder management capabilities.
  • Excellent verbal, written, and presentation skills.
  • Ability to drive accountability, engagement, and performance.
  • Demonstrated ability to build inclusive, diverse, and high-performing teams.
  • Bachelor’s or Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Pharmacy, or a related discipline, with significant industry experience; or a Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
  • At least 12 to 15+ years of pharmaceutical analytical development experience.
  • At least 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.

Responsibilities

  • 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.
  • 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 respond to regulatory agency queries.
  • 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.
  • 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 including 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.
  • 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 assigned scope of work.
  • Ensure adherence to environmental, health, and safety (EHS) policies and procedures.
  • Manage departmental resources and laboratory operational excellence initiatives.
  • Promote continuous improvement through digital and process excellence principles.

Desired Qualifications

  • Mass spectrometry expertise.
  • Preferred capabilities include budget management, 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, and team management.

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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