GlaxoSmithKline
Biologics Drug Product Life Cycle Management Leader
GlaxoSmithKline, King of Prussia, Pennsylvania, United States,
Job Description
The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, through a focused strategy execution.The
Biologics Drug Product Life Cycle Management Leader
is responsible for technical leadership of a given process stage (Drug Product). This role will provide leadership across multiple manufacturing sites as appropriate to ensure the implementation of the Product Control Strategy is standardized. The Biologics Drug Product Life Cycle Management Leader will support the Molecule Steward who has technical accountability for the product. This role is responsible for process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Responsibilities:
Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product: Technical Risk Assessment, Product Control Strategy, Stage 2 and Stage 3 (PPQ and CPV) Process Validation, Process Robustness Assessment, Leads cross functional improvement projects, and change implementation impact assessments on CQAs/CPPs. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards.Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites (primarily external to GSK), particularly MSAT, Production, Engineering and Quality.Leads the technology transfer between manufacturing sites, primarily externally while ensuring QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer to other sites.Leads cross functional improvement projects with a clear demonstration of value created.Provides leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations.Provides technical input to post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.Responds to technical questions during regulatory submission and inspections.Recommends Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved.Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.Basic Qualifications and Skills:
B.S. in Scientific, Engineering, Technical discipline or related field with 10 years of pharmaceutical experience; orMaster's degree in Scientific, Engineering, Technical discipline or related field with 8 years of pharmaceutical experience; orPh.D. in Scientific, Engineering, Technical discipline or related field with 4 years of pharmaceutical experience.Preferred Qualifications and Skills:
Demonstrated knowledge of late stage process development or MSAT roles supporting industrialization & commercialization.Demonstrated knowledge of technology transfer, with an understanding of the product development process, regulatory requirements for biopharmaceutical production.Excellent problem solver and ability to think and work creatively.Must have excellent verbal and written communication skills, and ability to influence, lead and drive change demonstrated through relevant work experiences.Broad and integrated knowledge and experience that can impact project and workgroup direction.Demonstrated knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.Track record of improving products, processes and trouble-shooting, execution of technical activities including validation activities.Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management.Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.Working knowledge of regulatory requirements in the industry and drug development.Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management), and knowledge management.
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The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, through a focused strategy execution.The
Biologics Drug Product Life Cycle Management Leader
is responsible for technical leadership of a given process stage (Drug Product). This role will provide leadership across multiple manufacturing sites as appropriate to ensure the implementation of the Product Control Strategy is standardized. The Biologics Drug Product Life Cycle Management Leader will support the Molecule Steward who has technical accountability for the product. This role is responsible for process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Responsibilities:
Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product: Technical Risk Assessment, Product Control Strategy, Stage 2 and Stage 3 (PPQ and CPV) Process Validation, Process Robustness Assessment, Leads cross functional improvement projects, and change implementation impact assessments on CQAs/CPPs. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards.Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites (primarily external to GSK), particularly MSAT, Production, Engineering and Quality.Leads the technology transfer between manufacturing sites, primarily externally while ensuring QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer to other sites.Leads cross functional improvement projects with a clear demonstration of value created.Provides leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations.Provides technical input to post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.Responds to technical questions during regulatory submission and inspections.Recommends Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved.Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.Basic Qualifications and Skills:
B.S. in Scientific, Engineering, Technical discipline or related field with 10 years of pharmaceutical experience; orMaster's degree in Scientific, Engineering, Technical discipline or related field with 8 years of pharmaceutical experience; orPh.D. in Scientific, Engineering, Technical discipline or related field with 4 years of pharmaceutical experience.Preferred Qualifications and Skills:
Demonstrated knowledge of late stage process development or MSAT roles supporting industrialization & commercialization.Demonstrated knowledge of technology transfer, with an understanding of the product development process, regulatory requirements for biopharmaceutical production.Excellent problem solver and ability to think and work creatively.Must have excellent verbal and written communication skills, and ability to influence, lead and drive change demonstrated through relevant work experiences.Broad and integrated knowledge and experience that can impact project and workgroup direction.Demonstrated knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management.Track record of improving products, processes and trouble-shooting, execution of technical activities including validation activities.Demonstrated experience in the Pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management.Demonstrated record of achievement and broad integrated knowledge of all aspects of biopharmaceutical production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.Working knowledge of regulatory requirements in the industry and drug development.Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e. CPV, PPR, Change and Deviation Management), and knowledge management.
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