Job Title - Technical Product Owner
Location - Baddi - #LI-Remote
Job Purpose
To manage and deliver the Solid oral, Liquids, sterile and topical dosage product portfolio, including new product introduction, and complex changes to existing products, input materials, processes, equipment technologies and manufacturing sites to meet business demands.
To ‘own’ and provide technical leadership for a product or product family at a local (site) and/or global level (across all sites where the product is manufactured), and to ensure that the product is delivered to the highest levels of quality and robustness.
To support PLM lead to ensure a successful PLM implementation & sustainability. Support on statistical analysis and statistical capability building in ES India.
Key Responsibilities
- Serve as the 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, ensuring product control strategies and mitigation plans remain current.
- Lead investigations and root-cause analysis for deviations, complaints, CAPAs, audit findings, and complex product-performance issues.
- Prepare and review technical documentation, including risk assessments, specifications, validation reports, qualification documents, and periodic product reviews.
- Collaborate across Quality, Operations, Engineering, R&D, suppliers, and global sites while coaching teams and strengthening technical and statistical capabilities.
Knowledge/ Education / Experience Required
A. Educational Background
Minimum Level of Education
M. Pharm. (Pharmaceutics) with up to 5 years of experience
Area of Specialisation
- Pharmaceutical manufacturing, technical operations, MSAT or product ownership.
- Experience in new product introduction, technology transfer or lifecycle management.
- Proven ability to lead technical investigations, root cause analysis and implement corrective actions.
Why is this Level of Education Required?
- To give the necessary level of knowledge and understanding to be able to lead a technical team in delivering new product introductions and complex changes.
- To demonstrate the appropriate level of scientific and technical understanding.
- Good communication skills in English and ability to work across functions and sites.
B. Job-Related Experience
Minimum Level of Job-Related Experience required
- Demonstrated experience in the pharmaceutical industry in leading the 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 strong understanding of product quality requirements
- Proven capability to lead teams, both line and matrix, in a Technical role.
- Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality requirements
- In depth knowledge and understanding of product dosage forms and their manufacturing processes.
- Familiarity with data analysis, statistical tools or digital product lifecycle tools.
Why is this Level of Experience Required?
- To give the necessary level of knowledge and understanding to be able to lead a technical team to deliver new product introductions and complex changes.
- In order to effectively and independently own and lead all elements of the Product Lifecycle for a specific product or product family.
- Experience working in a matrix organisation across geographies and cultures.
- Strong stakeholder management and supplier collaboration skills.
C. Other Job-Related Skills/Background
- Project management skills and experience on major technical projects, Resource management.
- Ability to use and interpret data to drive decision making at both tactical and strategic level
- Time management skills, ability to manage conflicting priorities
- Detailed knowledge of operational excellence tools e.g. FMEA, MSA, etc.
- Demonstrated problem solving and decision-making skills
- Strong communication, negotiating and influencing skills
- Experience with packaging components, primary containers or device qualification.
- Experience in sterile products, liquids, solids or topical dosage forms.
- Experience with validation protocols, qualification activities and risk assessments (FMEA, TRA).
- Familiarity with data analysis, statistical tools or digital product lifecycle tools.
- Strong numeracy, literacy, analytical skills, including technical report writing
- Knowledge of execution of NPI/technical trials
- Knowledge of process validation requirements
- Experience of process validation, scale-up and technical transfer
- Detailed knowledge of relevant dosage form including: unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallization, isolation, drying and particle size reduction), plant equipment and analytical testing. Awareness of device/packaging processes.
- Level 1 Practitioner for TRAs (‘Proficient’ level as defined by the TRA competency framework)
- The recommendation is for an L1 Capable or Accredited TRA Facilitator to serve as the site level PLM Change Agent or someone that has a good understanding of the PLM toolsets and how they work to bring benefit to the site.
- Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).
- Knowledge of regulatory environment, particularly in markets where product is commercialized.
- Track record of improving products, processes and trouble-shooting, execution of technical activities including trials and validation activities.
- Experienced in technology transfer, with an understanding of the product development process.
- Thorough knowledge of GMP and EHS requirements.
- Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA.
- Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders.
Skills
CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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