Product platform ASTL Lead
GlaxoSmithKline, King Of Prussia, PA, United States
Position Summary
This role is responsible for the delivery of business‑critical projects by supporting all the analytical aspects related to the late phase and lifecycle (PPQ/Commercial) for key GSK products. It defines the strategy and leads the implementation of the E2E Analytical control strategies, technology transfers and provides technical and analytical support across the product lifecycle, while ensuring New product introductions and product‑related strategic programs within the GSK GSC.
Responsibilities
Leading, developing and coaching a team of Analytical Science & technology leaders accountable for GSK products analytical life‑cycle management.
Being accountable for the E2E life‑cycle Analytical control strategy, providing expertise for product critical quality attribute assessment, specification, comparability criteria setting.
Leading cross‑functional, cross‑site teams, covering all analytical aspects in the frame of GSK strategic products and projects and bringing the Products specific analytical and stability expertise to multi‑disciplinary technical teams and Governance bodies.
Coordinating complex analytical investigations making use of scientific principles and professional practices to solve problems in creative and practical ways and driving implementation of appropriate corrective and preventative actions.
Independently reviewing existing process, analytical development and production data; supporting design of experiments; recommending changes and improvements to the control strategy.
Providing scientific support and mentorship in the development, scale‑up, optimization and operation of methods for the production, purification and testing of new process formulas, technologies, and products.
Being accountable for the analytical part of regulatory submissions and RTQ process.
Authoring, reviewing and/or approving experimental protocols/reports in the frame of comparability studies.
Supporting sites on analytical control strategy matters during regulatory inspections.
Maintaining and demonstrating significant knowledge of state‑of‑the‑art principles and theories in area of responsibility.
Basic Qualifications
BSc in Biochemistry, Biology, Chemistry, Pharmacy or another related scientific field.
Ph.D. 10+ years’ experience, MS 12+ years’, BS 15+ years’ in (Bio)Pharma industry.
Experience in Analytical Technologies.
Experience in development, qualification and validation of analytical methods.
Experience of New Product Introduction and Manufacturing Operations.
Experience of working with regulatory agencies in the frame of IND/BLA for (Bio)Therapeutics or vaccines and to GMP standards.
Experience in matrix leadership and project management.
Preferred Qualifications
Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements.
Experienced in technology transfer, with an understanding of the product development process and manufacturing.
Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
Project management and prioritization skills gained within a complex matrix.
Track record of improving products, processes and troubleshooting, execution of technical activities including experimentation and analytical methods validation activities.
Excellent problem solver and ability to think and work creatively. Demonstrated experience leading technical aspects of root cause analysis investigations.
Demonstrated experience in the (Bio)Pharmaceutical industry in leading the technical aspects of Product Lifecycle Management.
Demonstrated knowledge of Quality by Design and risk management approaches.
People management.
Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and CMO/CRO.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr
This role is responsible for the delivery of business‑critical projects by supporting all the analytical aspects related to the late phase and lifecycle (PPQ/Commercial) for key GSK products. It defines the strategy and leads the implementation of the E2E Analytical control strategies, technology transfers and provides technical and analytical support across the product lifecycle, while ensuring New product introductions and product‑related strategic programs within the GSK GSC.
Responsibilities
Leading, developing and coaching a team of Analytical Science & technology leaders accountable for GSK products analytical life‑cycle management.
Being accountable for the E2E life‑cycle Analytical control strategy, providing expertise for product critical quality attribute assessment, specification, comparability criteria setting.
Leading cross‑functional, cross‑site teams, covering all analytical aspects in the frame of GSK strategic products and projects and bringing the Products specific analytical and stability expertise to multi‑disciplinary technical teams and Governance bodies.
Coordinating complex analytical investigations making use of scientific principles and professional practices to solve problems in creative and practical ways and driving implementation of appropriate corrective and preventative actions.
Independently reviewing existing process, analytical development and production data; supporting design of experiments; recommending changes and improvements to the control strategy.
Providing scientific support and mentorship in the development, scale‑up, optimization and operation of methods for the production, purification and testing of new process formulas, technologies, and products.
Being accountable for the analytical part of regulatory submissions and RTQ process.
Authoring, reviewing and/or approving experimental protocols/reports in the frame of comparability studies.
Supporting sites on analytical control strategy matters during regulatory inspections.
Maintaining and demonstrating significant knowledge of state‑of‑the‑art principles and theories in area of responsibility.
Basic Qualifications
BSc in Biochemistry, Biology, Chemistry, Pharmacy or another related scientific field.
Ph.D. 10+ years’ experience, MS 12+ years’, BS 15+ years’ in (Bio)Pharma industry.
Experience in Analytical Technologies.
Experience in development, qualification and validation of analytical methods.
Experience of New Product Introduction and Manufacturing Operations.
Experience of working with regulatory agencies in the frame of IND/BLA for (Bio)Therapeutics or vaccines and to GMP standards.
Experience in matrix leadership and project management.
Preferred Qualifications
Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements.
Experienced in technology transfer, with an understanding of the product development process and manufacturing.
Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.
Project management and prioritization skills gained within a complex matrix.
Track record of improving products, processes and troubleshooting, execution of technical activities including experimentation and analytical methods validation activities.
Excellent problem solver and ability to think and work creatively. Demonstrated experience leading technical aspects of root cause analysis investigations.
Demonstrated experience in the (Bio)Pharmaceutical industry in leading the technical aspects of Product Lifecycle Management.
Demonstrated knowledge of Quality by Design and risk management approaches.
People management.
Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and CMO/CRO.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr