GSK · 5 hours ago
Technical Product Owner
Field Worker - IND Rx
Full-time
Onsite
Senior Level
5+ years expGSK is a global biopharma company dedicated to improving health through innovative medicines and vaccines. The Technical Product Owner will oversee product performance across manufacturing sites in India, collaborating with cross-functional teams to ensure product safety and quality while driving technical improvements and lifecycle management.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead the technical aspects of new product introduction, ensuring a smooth handover to production and supporting product transfers within the India Supply Chain network
Provide technical leadership for complex product performance investigations and support the introduction and improvement of process technologies and capabilities
Maintain product and process knowledge throughout the product lifecycle, promoting technical standards and ensuring robust systems to track, trend, and analyze product performance
Apply and maintain product performance targets, influencing manufacturing, analytical processes, packaging, devices, and specifications, including input into lifecycle validation approaches
Ensure all aspects of Product Lifecycle Management are in place and actively maintained, including Technical Risk Assessment, Product Control Strategy, Continued Process Verification, and Process Robustness Assessment
Participate in PLM forums and communities of practice, deploy standard PPA tools for Continuous Process Verification, and lead reviews for product performance analysis
Assess the impact of technical changes on product quality, especially those affecting critical quality attributes and process parameters, through thorough risk assessment and review processes; and identify, escalate, and mitigate risks within quality systems
Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 APl/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc
Build and maintain key relationships across Operations, Technical, Quality, and Engineering, and provide leadership and technical input for investigations, audits, and compliance activities
Identify, develop, and train successors, coach others in technical expertise, and ensure that all relevant functions have the necessary product knowledge to execute their roles effectively
Qualification
Required
MS (Pharmaceutics) or M. Pharm. (Pharmaceutics) with 5 to 10 years of experience
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 dose forms and their manufacturing processes
Demonstrated experience in the Pharmaceutical or FMCG 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
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
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 2 Mentor 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
Preferred
Ph. D. with minimum 3 to 5 years of experience in the field of pharmaceutical industry
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase