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Johnson & Johnson Hiring for Manager – Analytical Development in Mumbai: ARD Analytics
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Johnson & Johnson Innovative Medicine India |
| Designation / Track | Manager – Analytical Development (Analytics) |
| Target Qualifications | M.Pharm Analysis / Pharmaceutics, Ph.D, M.Sc Analytical Chemistry |
| Experience Profile | 7 to 12 Years Industrial Formulation & Analytical R&D Experience |
| Core Focus | Method Validation (ICH Q2), Impurity Characterization, Nitrosamines & Dissolution Sciences |
| Work Location | Mumbai, Maharashtra, India |
| Application Mode | Direct Official Johnson & Johnson Global Workday Requisition |
Verified Vacancy Matrix & Hiring Tracks
Review all active hiring tracks below. Direct official application links for each position are provided at the bottom of this notification:
| # | Designation & Hiring Track | Work Location | Experience & Mode |
|---|---|---|---|
| 1 |
#1Manager – Analytical Development (Analytics)
Analytical Research & Development (ARD) |
Location: Mumbai
|
Experience: 7 – 12 Yrs Online Portal
|
Key Roles & Detailed Responsibilities
- Perform daily analytical testing of raw materials, in-process samples, finished products, and stability batches in compliance with Johnson & Johnson’s validated Standard Testing Procedures (STPs).
- Operate, calibrate, and troubleshoot high-end analytical instrumentation including HPLC (Empower 3), Gas Chromatography (GC), UV-Vis, and dissolution apparatus.
- Maintain complete and contemporaneous laboratory documentation adhering strictly to ALCOA+ data integrity principles and cGMP standards.
- Participate in laboratory investigations for Out of Specification (OOS) and Out of Trend (OOT) results, implementing verified CAPA protocols.
Eligibility Criteria & Candidate Profile
- Academic Qualifications: Candidates must possess M.Pharm Pharmaceutical Analysis / Chemistry, Ph.D, M.Sc Analytical Chemistry from an accredited university or approved technical institution.
- Experience Profile: 7 – 12 Years Experience with demonstrated hands-on technical proficiency in target operational workflows.
- Regulatory & Quality Knowledge: Solid foundational awareness of pharmaceutical compliance (cGMP, ICH-GCP, GLP, 21 CFR Part 11, or CDSCO standards).
- Core Competencies: Excellent analytical problem-solving skills, rigorous documentation hygiene, and strong verbal/written technical communication.
Core Technical Competencies & Instruments Matrix
Candidates possessing hands-on proficiency across the following analytical tools, software systems, and regulatory standards will receive priority evaluation:
HPLC (Waters Alliance / Agilent 1260 / 1290)Gas Chromatography (GC – FID / Headspace)Empower 3 / OpenLab Chromatography Data SystemsUV-Visible Spectrophotometry & Dissolution Testing (USP I/II)Karl Fischer & Potentiometric Auto-TitrationAnalytical Method Validation & Transfer (ICH Q2 R1)Finished Product, In-Process & Stability TestingALCOA+ Data Integrity & 21 CFR Part 11 Audit TrailsOut of Specification (OOS / OOT) Phase I/II InvestigationsLaboratory Information Management Systems (LIMS)
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for Manager – Analytical Development (Analytics):
Duty 1Sample Intake, Allocation & LIMS Log-In
Receiving finished product, in-process, raw material, and stability samples; verifying physical integrity, batch numbers, and generating unique test tracking barcodes in LIMS.
Duty 2Mobile Phase Preparation & System Suitability (SST)
Preparing HPLC/GC mobile phases, buffer filtration, sonication, standard solution preparation, and running mandatory SST injections on Waters Empower 3 / Agilent OpenLab.
Duty 3Chromatographic & Wet Chemistry Analysis
Executing assay, related substances (RS), dissolution profile, residual solvents, or Karl Fischer titrations strictly per approved Standard Testing Procedures (STPs).
Duty 4Chromatographic Data Processing & ALCOA+ Audit Trails
Integrating peaks with validated processing methods, checking baseline separation, and reviewing audit trails to ensure 100% data integrity without manual overrides.
Duty 5OOS / OOT Escalation & Documentation
Contemporaneously recording raw data in analytical workbooks, verifying calculation formulas, and immediately logging Phase I lab investigations if any out-of-specification result occurs.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
USFDA 21 CFR Part 211.160 / 211.194
General Laboratory Controls
Mandates scientifically sound laboratory controls, specifications, testing protocols, standards, and complete raw laboratory records.
ICH Q2 (R1)
Validation of Analytical Procedures
Provides global regulatory definitions and validation criteria for specificity, linearity, range, accuracy, precision, LOD, LOQ, and robustness.
ICH Q1A to Q1E
Stability Testing Guidelines
Regulates stability testing protocols across climatic zones, photo-stability, and mathematical evaluation of shelf-life data.
USFDA 21 CFR Part 11 & ALCOA+
Electronic Records & Data Integrity
Enforces strict user credentialing, automated immutable audit trails, and contemporaneous time-stamping for all chromatographic systems.
Tailored Resume Guidelines for Manager – Analytical Development (Analytics)
- Highlight Core Technical Instrumentation & Software: Explicitly mention hands-on software platforms (Empower 3, SAS, Argus, EDC Rave) or laboratory equipment relevant to Manager – Analytical Development (Analytics) at the top of your resume.
- Quantify Accomplishments & Throughput: Instead of passive duty descriptions, quantify measurable deliverables (e.g., ‘Validated 15+ analytical methods per ICH Q2’, ‘Processed 120+ clinical safety ICSRs per month’, ‘Supervised 50+ commercial batches with zero deviations’).
- Standardize on ATS-Friendly Clean Formatting: Use standard single-column reverse-chronological format with clean bullet points. Strictly avoid multi-column layouts, graphics, icons, or text boxes that confuse automated enterprise ATS parsers.
- Calibrate Regulatory Terminology: Integrate exact industry compliance acronyms (e.g., cGMP, ICH-GCP, ALCOA+, 21 CFR Part 11, USFDA audit readiness) naturally throughout your project and experience narratives.
Technical Interview Assessment & Guidance
Q: What is the operational distinction between System Suitability Testing (SST) and Method Validation in HPLC analysis?
Authoritative Answer: System Suitability Testing (SST) is a mandatory daily verification conducted prior to sample analysis to confirm that the complete analytical system (instrument, column, mobile phase, and detector) operates with acceptable precision and resolution. Key SST parameters include Theoretical Plates (>2000), Tailing Factor (<1.5 or 2.0), and %RSD of peak areas across replicate injections (typically ≤1.0% or 2.0%). In contrast, Method Validation (per ICH Q2 R1) is a comprehensive, one-time documented validation proving that a test procedure is suitable for its intended regulatory purpose across parameters including Specificity, Linearity, Range, Accuracy, Precision, LOD, LOQ, and Robustness.
Authoritative Answer: System Suitability Testing (SST) is a mandatory daily verification conducted prior to sample analysis to confirm that the complete analytical system (instrument, column, mobile phase, and detector) operates with acceptable precision and resolution. Key SST parameters include Theoretical Plates (>2000), Tailing Factor (<1.5 or 2.0), and %RSD of peak areas across replicate injections (typically ≤1.0% or 2.0%). In contrast, Method Validation (per ICH Q2 R1) is a comprehensive, one-time documented validation proving that a test procedure is suitable for its intended regulatory purpose across parameters including Specificity, Linearity, Range, Accuracy, Precision, LOD, LOQ, and Robustness.
Q: How do you investigate and document an Out of Specification (OOS) result in accordance with USFDA guidance?
Authoritative Answer: An OOS investigation initiates with Phase I Laboratory Investigation prior to discarding any test solutions. The analyst immediately notifies the QC Supervisor and checks: calculation accuracy, instrument calibration, system suitability compliance, sample dilution/weighing errors, column performance, and chromatographic integration. If a clear laboratory assignable cause is identified with documented proof, the initial test is invalidated and re-testing is performed on the original sample. If no laboratory error is found, Phase II Manufacturing Investigation is launched with QA oversight to audit the batch manufacturing record (BMR), equipment cleaning, raw material lots, and environmental conditions.
Authoritative Answer: An OOS investigation initiates with Phase I Laboratory Investigation prior to discarding any test solutions. The analyst immediately notifies the QC Supervisor and checks: calculation accuracy, instrument calibration, system suitability compliance, sample dilution/weighing errors, column performance, and chromatographic integration. If a clear laboratory assignable cause is identified with documented proof, the initial test is invalidated and re-testing is performed on the original sample. If no laboratory error is found, Phase II Manufacturing Investigation is launched with QA oversight to audit the batch manufacturing record (BMR), equipment cleaning, raw material lots, and environmental conditions.
Q: How are ALCOA+ Data Integrity principles enforced across chromatographic workstations?
Authoritative Answer: ALCOA+ mandates that analytical data must be Attributable (unique user credentials with zero shared logins), Legible (permanent, readable electronic records), Contemporaneous (time-stamped at the moment of execution), Original (first raw data file without manual recalculation or suppression), and Accurate (validated integration methods). The ‘+’ criteria enforce that records must be Complete (including metadata, audit trails, and aborted injections), Consistent (chronological sequence), Enduring (secure archiving), and Available for regulatory inspection throughout the document retention period.
Authoritative Answer: ALCOA+ mandates that analytical data must be Attributable (unique user credentials with zero shared logins), Legible (permanent, readable electronic records), Contemporaneous (time-stamped at the moment of execution), Original (first raw data file without manual recalculation or suppression), and Accurate (validated integration methods). The ‘+’ criteria enforce that records must be Complete (including metadata, audit trails, and aborted injections), Consistent (chronological sequence), Enduring (secure archiving), and Available for regulatory inspection throughout the document retention period.
Mandatory Documents Checklist for Interview & Verification
Ensure you organize the following original credentials and self-attested photocopies for technical interviews and HR onboarding verification:
Curriculum Vitae (2 Hard Copies)
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Academic Certificates & Marksheets
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Government Photo Identification
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Past 3 Months Salary Slips & Bank Records
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Relieving & Appointment Letters
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Passport Photographs & Professional Registration
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
Frequently Asked Questions (FAQ)
Q: What is the official application procedure for Manager – Analytical Development (Analytics) at Johnson & Johnson?
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Johnson & Johnson’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Johnson & Johnson’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Q: What academic backgrounds and degrees are eligible for this hiring drive?
Answer: Eligible qualifications include M.Pharm Pharmaceutical Analysis / Chemistry, Ph.D, M.Sc Analytical Chemistry. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Answer: Eligible qualifications include M.Pharm Pharmaceutical Analysis / Chemistry, Ph.D, M.Sc Analytical Chemistry. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Q: What is the typical interview and shortlisting workflow?
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for Manager – Analytical Development (Analytics) at Johnson & Johnson:
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Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for Manager – Analytical Development (Analytics) at Johnson & Johnson above.
- Calibrate your resume to highlight relevant instrumentation, software platforms, or cGMP/GCP regulatory compliance.
- Ensure your contact details, active mobile number, and email address are up to date in your CV.
- Click the official application button below to access the direct employer recruitment portal or HR email channel with zero intermediary charges.
Submit Official Application – Manager – Analytical Development (Analytics) at Johnson & Johnson
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