Senior Manager/Associate Director - Biologic Services (conjugation)

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

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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 an 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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