GlaxoSmithKline
MSAT Standards and Contamination Control Associate Director
GlaxoSmithKline, King of Prussia, Pennsylvania, United States
Overview
At GSK, we manufacture and supply medicines and vaccines to meet patients’ needs. Our supply chain is vital to bringing innovations to patients quickly, efficiently and effectively. We are leveraging smart manufacturing technologies including robotics, digital solutions and artificial intelligence. We are hiring a
MSAT Standards and Contamination Control Associate Director
to join the Manufacturing Science and Technology (MSAT) organization in Upper Merion. This site-based role provides technical support to ensure Upper Merion Biopharm site goals are achieved. The MSAT team ensures manufacturing processes are capable, compliant and productive while maintaining product quality, and delivers continuous improvements to the supply chains supported by UM Biopharm and global MSAT through technology transfers and process-related improvement programs across the product lifecycle. In this role, you will lead a team to develop technical standards and processes in areas including contamination control, single-use systems, lifecycle management, cleaning validation, leachables and extractables, and cell banking. You will become a subject matter expert to provide technical support, resolve challenges, implement best practices, and support process improvements. You will also lead cell bank management at Upper Merion, supporting inventory management, transfer, and technical oversight of the cell bank portfolio. The MSAT Standards and Contamination Control Associate Director will develop systems and processes to build a technically capable, motivated, and energized MSAT team. You will support technical and leadership capability development with a focus on the future skills the MSAT team will need. You will manage within a matrix team, collaborating with other UM Biopharm departments and global MSAT stakeholders. This role will provide you the opportunity to lead key activities to progress your career, including some of the following responsibilities: Lead a team of technical experts across contamination control, single-use systems, cleaning validation, lifecycle management, leachables and extractables, and cell banking. In alignment with global MSAT, develop and maintain technical standards 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. Define the approach and strategy for the team in alignment with global MSAT, and stay 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 teams (production, engineering, quality) and with global teams, including a strong partnership with the global MSAT technical standards team. Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree with a minimum of 8 years of experience OR a Master’s (MS) degree 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, research & development and/or manufacturing Preferred Qualifications
If you have the following characteristics, it would be a plus: 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 separations and 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; ability to influence cross-functionally and drive improvements Strong verbal and written communication skills in technical and regulatory matters This role is on-site, offering opportunities to engage directly with teams and processes to make a tangible impact. #LI-GSK Please note: GSK provides information about benefits and other company programs for US employees. If you require an accommodation or other assistance to apply, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state, or local law.
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At GSK, we manufacture and supply medicines and vaccines to meet patients’ needs. Our supply chain is vital to bringing innovations to patients quickly, efficiently and effectively. We are leveraging smart manufacturing technologies including robotics, digital solutions and artificial intelligence. We are hiring a
MSAT Standards and Contamination Control Associate Director
to join the Manufacturing Science and Technology (MSAT) organization in Upper Merion. This site-based role provides technical support to ensure Upper Merion Biopharm site goals are achieved. The MSAT team ensures manufacturing processes are capable, compliant and productive while maintaining product quality, and delivers continuous improvements to the supply chains supported by UM Biopharm and global MSAT through technology transfers and process-related improvement programs across the product lifecycle. In this role, you will lead a team to develop technical standards and processes in areas including contamination control, single-use systems, lifecycle management, cleaning validation, leachables and extractables, and cell banking. You will become a subject matter expert to provide technical support, resolve challenges, implement best practices, and support process improvements. You will also lead cell bank management at Upper Merion, supporting inventory management, transfer, and technical oversight of the cell bank portfolio. The MSAT Standards and Contamination Control Associate Director will develop systems and processes to build a technically capable, motivated, and energized MSAT team. You will support technical and leadership capability development with a focus on the future skills the MSAT team will need. You will manage within a matrix team, collaborating with other UM Biopharm departments and global MSAT stakeholders. This role will provide you the opportunity to lead key activities to progress your career, including some of the following responsibilities: Lead a team of technical experts across contamination control, single-use systems, cleaning validation, lifecycle management, leachables and extractables, and cell banking. In alignment with global MSAT, develop and maintain technical standards 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. Define the approach and strategy for the team in alignment with global MSAT, and stay 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 teams (production, engineering, quality) and with global teams, including a strong partnership with the global MSAT technical standards team. Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree with a minimum of 8 years of experience OR a Master’s (MS) degree 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, research & development and/or manufacturing Preferred Qualifications
If you have the following characteristics, it would be a plus: 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 separations and 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; ability to influence cross-functionally and drive improvements Strong verbal and written communication skills in technical and regulatory matters This role is on-site, offering opportunities to engage directly with teams and processes to make a tangible impact. #LI-GSK Please note: GSK provides information about benefits and other company programs for US employees. If you require an accommodation or other assistance to apply, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state, or local law.
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