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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing the product lifecycle for solid, liquid, sterile, and topical dosage forms, with a strong focus on technical leadership, risk management, and compliance with Good Manufacturing Practices (GMP). Proven ability to lead cross-functional teams and drive product improvements through data analysis and validation activities.
Highest-signal resume keywords
Technical Product OwnershipNew Product IntroductionRoot Cause AnalysisGood Manufacturing Practices (GMP)Statistical Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Pharmaceutical ManufacturingTechnology TransferProcess ValidationRisk AssessmentsProduct Control StrategiesStatistical ToolsValidation ProtocolsDosage Forms KnowledgeOperational Excellence ToolsProject Management
Soft Skills
Strong Communication SkillsTeam LeadershipCoaching
Tools & Technologies
Digital Product Lifecycle ToolsFMEAMSA
Certifications & Qualifications
M. Pharm. (Pharmaceutics)Level 1 Practitioner for TRAs
Industry Keywords
Regulatory RequirementsMHRAFDAEHS RequirementsProduct Quality Requirements
About the role
Key responsibilities & impact- Manage and deliver the solid oral, liquid, sterile and topical dosage product portfolio
- Own and provide technical leadership for products or product families at local and/or global level
- Serve as Technical Product Owner throughout the product lifecycle
- Lead new product introductions, technology transfers, scale-up, validation and handover to manufacturing sites and contract partners
- Own product technical knowledge, performance monitoring, process capability, robustness and continuous process verification
- Assess and approve technical changes using risk management tools
- Maintain current product control strategies and mitigation plans
- Lead investigations and root-cause analysis for deviations, complaints, CAPAs, audit findings and complex product-performance issues
- Prepare and review risk assessments, specifications, validation reports, qualification documents and periodic product reviews
- Support PLM lead with implementation and sustainability
- Support statistical analysis and statistical capability building in ES India
- Collaborate with Quality, Operations, Engineering, R&D, suppliers and global sites
- Coach teams and strengthen technical and statistical capabilities
Requirements
What you’ll need- M. Pharm. (Pharmaceutics) with up to 5 years of experience
- Specialisation in pharmaceutical manufacturing, technical operations, MSAT or product ownership
- Experience in new product introduction, technology transfer or lifecycle management
- Experience leading technical investigations, root cause analysis and corrective actions
- Experience leading technical aspects of the product lifecycle, including technology transfers, technical risk assessments, product control strategies, process capability/robustness, QbD, validation and change control
- Knowledge of Good Manufacturing Practices (GMP) and product quality requirements
- Capability to lead line and matrix teams in a technical role
- Knowledge of external regulatory requirements, including MHRA and FDA
- Knowledge of product dosage forms and manufacturing processes
- Familiarity with data analysis, statistical tools or digital product lifecycle tools
- Experience working in a matrix organisation across geographies and cultures
- Project management and resource management skills
- Ability to use and interpret data for tactical and strategic decision-making
- Knowledge of operational excellence tools such as FMEA and MSA
- Experience with packaging components, primary containers or device qualification
- Experience in sterile, liquid, solid or topical dosage forms
- Experience with validation protocols, qualification activities and risk assessments
- Experience with process validation, scale-up and technical transfer
- Knowledge of dosage-form unit operations, formulation-material functionality and criticality, plant equipment and analytical testing
- Level 1 Practitioner for TRAs, or understanding of PLM toolsets and their site benefits
- Knowledge of regulatory environments in product markets
- Track record of product/process improvement and technical trials and validation activities
- Thorough knowledge of GMP and EHS requirements
- Ability to assess and interpret statistical data, including process capability, control charts, DoE and MSA
- Strong English communication skills and technical report writing ability
Benefits
Comp & perks- Inclusion and recruitment-process adjustments available upon request
- Opportunity to work for a global biopharma company focused on specialty medicines and vaccines
- Environment intended to support employee growth and wellbeing