GSK
MSAT Standards and Contamination Control Associate Director
GSK, King Of Prussia, Pennsylvania, United States, 19406
Overview
MSAT Standards and Contamination Control Associate Director role at GSK in King of Prussia, PA. The MSAT organization provides technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team delivers continuous improvements to the existing supply chains and collaborates with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle. Responsibilities
Lead a team of technical experts across key disciplines including contamination control, single-use systems, cleaning validation, lifecycle management, leachables and extractables, and cell banking. In alignment with global MSAT, develop and maintain the technical standards in these areas for Upper Merion. Serve as a technical enterprise leader across the Upper Merion site to support investigations, global initiatives, risk assessments, technology transfers, and regulatory/audit activities in these areas of responsibility. Define the approach and strategy for the team in alignment with global MSAT, staying current on industry trends and best practices. Manage the Upper Merion cell bank portfolio and key cell bank activities and documentation. Manage relationships with internal stakeholders (production, engineering, quality) and global teams, including a strong partnership with the global MSAT technical standards team. Qualifications
Basic Qualifications: Bachelors with a minimum of 8 years OR a Masters (MS) with a minimum of 5 years OR PhD with a minimum of 3 years of post-graduate experience in the biopharmaceutical or pharmaceutical industry. Experience in biopharmaceutical or vaccines technologies, R&D and/or manufacturing. Preferred Qualifications: Experience in biopharmaceutical technologies and/or manufacturing with a strong technical understanding of bioprocesses for drug substance (upstream and downstream, including large-scale cell culture bioprocessing and bioprocess purification technologies). Deep understanding of current industry trends, ICH guidelines, and GMP principles, particularly in contamination control, single-use systems, and process validation. Understanding of process validation, process development, technology transfer, and product lifecycle management. Strong interpersonal and leadership skills to manage cross-functional teams and influence improvements. Strong verbal and written communication skills in technical and regulatory matters. On-site / Benefits
This role is on-site, offering opportunities to engage directly with teams and processes to make a tangible impact. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We are committed to equal opportunity employment. GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). Important notice to Employment businesses/ Agencies: GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. Prior written authorization is required before referring any candidates to GSK. This is to ensure compliance with company policy. Note: If you are a US Licensed Healthcare Professional, GSK may capture and report expenses in relation to interviews in accordance with federal and state US transparency requirements. For more information, please visit the CMS Open Payments website.
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MSAT Standards and Contamination Control Associate Director role at GSK in King of Prussia, PA. The MSAT organization provides technical support to ensure Upper Merion Biopharm site goals and objectives are achieved. The primary objective of MSAT is to ensure manufacturing processes are capable, compliant and productive while ensuring product quality. The site MSAT team delivers continuous improvements to the existing supply chains and collaborates with global MSAT to execute technology transfers and implement process-related improvement programs across the product lifecycle. Responsibilities
Lead a team of technical experts across key disciplines including contamination control, single-use systems, cleaning validation, lifecycle management, leachables and extractables, and cell banking. In alignment with global MSAT, develop and maintain the technical standards in these areas for Upper Merion. Serve as a technical enterprise leader across the Upper Merion site to support investigations, global initiatives, risk assessments, technology transfers, and regulatory/audit activities in these areas of responsibility. Define the approach and strategy for the team in alignment with global MSAT, staying current on industry trends and best practices. Manage the Upper Merion cell bank portfolio and key cell bank activities and documentation. Manage relationships with internal stakeholders (production, engineering, quality) and global teams, including a strong partnership with the global MSAT technical standards team. Qualifications
Basic Qualifications: Bachelors with a minimum of 8 years OR a Masters (MS) with a minimum of 5 years OR PhD with a minimum of 3 years of post-graduate experience in the biopharmaceutical or pharmaceutical industry. Experience in biopharmaceutical or vaccines technologies, R&D and/or manufacturing. Preferred Qualifications: Experience in biopharmaceutical technologies and/or manufacturing with a strong technical understanding of bioprocesses for drug substance (upstream and downstream, including large-scale cell culture bioprocessing and bioprocess purification technologies). Deep understanding of current industry trends, ICH guidelines, and GMP principles, particularly in contamination control, single-use systems, and process validation. Understanding of process validation, process development, technology transfer, and product lifecycle management. Strong interpersonal and leadership skills to manage cross-functional teams and influence improvements. Strong verbal and written communication skills in technical and regulatory matters. On-site / Benefits
This role is on-site, offering opportunities to engage directly with teams and processes to make a tangible impact. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We are committed to equal opportunity employment. GSK is an Equal Opportunity Employer. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). Important notice to Employment businesses/ Agencies: GSK does not accept referrals from employment businesses and/or employment agencies for vacancies posted on this site. Prior written authorization is required before referring any candidates to GSK. This is to ensure compliance with company policy. Note: If you are a US Licensed Healthcare Professional, GSK may capture and report expenses in relation to interviews in accordance with federal and state US transparency requirements. For more information, please visit the CMS Open Payments website.
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