Biologics Drug Product Life Cycle Management Leader

1 month ago

King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Jul

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. Biologics Drug Product Life Cycle Management Leader 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; or
  • Master's degree in Scientific, Engineering, Technical discipline or related field with 8 years of pharmaceutical experience; or
  • Ph.D. in 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.


Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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