Senior Manager/Associate Director - Biologic Services (Conjucation)

Site Name : USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence

Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.

Posted Date : Jun 18 2024

The Senior Manager / Associate Director, Biologic Services, Strategic External Development will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs), provides technical guidance and support to the advancement of cost effective, and safe manufacturing processes for the manufacture of antibody-drug conjugates (ADCs) drug substance.

The incumbent will be responsible for establishing and maintaining a solid understanding of current industry trends with ADC payload linker and conjugation technologies, support due diligence projects for antibody-drug conjugates (ADCs) assets, interacting with internal and / or external research and development groups to support pre-clinical study material generation, and support clinical phase conjugation process development and technology transfer activities as needed.

It extends further to act as a SME to address specific dossier considerations for ADC regulatory submissions and / or patent filings.

This position is integral to the advancement of GSK's growing portfolio of ADC drug candidates and technology programs. She / he will be expected to represent GSK at scientific and regulatory meetings as needed.

The scope of the role encompasses a wide breadth of lifecycle, ranging from preclinical toxicity process, first-time in-patient process development, late-stage development, and process validation and commercialization.

In this role she / he will be expected to work in a cross-functional team environment to act as a conjugation SME, provide technical support and troubleshooting to ADC project teams to address technical challenges and ensure successful delivery with regards to conjugation process development and technology transfer.

She / he will also contribute to the identification and selection of Contract Research Organizations (CROs) and Contract Development Manufacturing Organizations (CDMOs) and building / maintaining strong working relationships with their respective technical staff and management.

This position will require travel, not to exceed 30% (domestic and international).

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :

• Serve as a conjugation SME to support the development and scale up of antibody-drug conjugate development programs along with supporting other Biopharma projects.
• Collaborate and coordinate in cross-functional teams, both internally and externally with in-license partners and CDMOs for developing robust, scalable, cost effective and safe ADC conjugation processes.
• Troubleshoot new and existing product or process issues related to yield, quality, and throughput for ADC projects.
• Support due diligence projects for ADC assets.
• Interact with internal and / or external research and development groups to support pre-clinical study material generation, and support clinical phase conjugation process development and technology transfer activities.
• Prepare CMC documentation for regulatory and / or patent filings and prepare / reconcile responses for responsible topics.
• Establish and maintain a solid understanding of current trends in ADC payload linker and conjugation technologies.
• Provide clear communication to cross functional teams and functional line management regarding progress against technical objectives / milestones.
• Ensure well-organized, clear and complete documentations of all activities across areas of responsibility.

Basic Qualifications :

We are looking for professionals with these required skills to achieve our goals :

• Ph.D. in engineering, chemistry, biology, or closely related fields with 5+ industry experience
• Or, MS with 7+ industry experience.
• Or, BS with 10+ years of industry experience
• Experience with ADC conjugation / bio-conjugation process development and technology transfer.
• Experience building relationships and working with ADC conjugation CDMOs.
• Experience with cGMP regulations.
• Experience in preparing CMC documentation for regulatory submissions.

Preferred Qualifications :

If you have the following characteristics, it would be a plus :

• Proven ability to manage projects and work with cross-functional teams comprised of internal and / or external contacts.
• Excellent written and oral communication skills, including the maintenance of technical data and reports; proactive collaboration in a multi-disciplinary business and science team environment is essential.
• Experience with vaccines.
• Experience working in R&D, understand ADC payload / linker design principles, have good understanding of ADC molecules’ mechanisms of action.
• Experience with design of experiments (DoE) and modeling tools.
• Experience in preparing regulatory CMC sections for ADC molecules.

LI-GSK

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

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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).

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