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Senior Manager/Associate Director - Biologic Services (conjugation)
Location:
King Of Prussia, PA
Description:
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-GSKPlease visit GSK US Benefits Summary to 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 1-877-694-XXXX (US Toll Free) or +1 801 567 XXXX (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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.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.PDN-9c380ebc-0121-4938-8ed1-d219557d166e
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More About this Listing: Senior Manager/Associate Director - Biologic Services (conjugation)
Senior Manager/Associate Director - Biologic Services (conjugation) is a Executive Associate Director Job at GSK located in King Of Prussia PA. Find other listings like Senior Manager/Associate Director - Biologic Services (conjugation) by searching Oodle for Executive Associate Director Jobs.
Senior Manager/Associate Director - Biologic Services (conjugation) is a Executive Associate Director Job at GSK located in King Of Prussia PA. Find other listings like Senior Manager/Associate Director - Biologic Services (conjugation) by searching Oodle for Executive Associate Director Jobs.