Posted:
7/3/2024, 2:20:43 PM
Location(s):
Maryland, United States ⋅ Rockville, Maryland, United States
Experience Level(s):
Senior
Field(s):
Product
Are you energized by a highly visible role that allows you to bring cutting edge science and engineering to drive business performance? Are you passionate about being a brilliant leader and facilitating a culture where people can thrive and do their best work? If so, our Head of Site MSAT (Manufacturing, Science and Technology) role at our Rockville, MD biopharmaceutical manufacturing site could be an excellent opportunity to explore!
As Head of Site MSAT for Rockville you have overall accountability development of capable processes and driving continuous improvement across the life cycle of critical products for GSK interfacing with sites across the globe to share, learn and grow.
This role, as part of the site leadership team, is accountable for developing both a high performing MSAT organization and being active in building the overall culture to create a best-in-class manufacturing facility for GSK.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Enterprise leadership driving enterprise initiatives, shaping the site’s strategic direction, and creating a strong shadow of the leader across 600+ team members.
Direct the transfer of drug substance biopharmaceutical production processes and technologies from R&D, third party clients, or MSAT labs to/from Rockville Biopharm.
Accountable for product technical lifecycle management driving process/yield improvements, robust process knowledge management and ensuring accuracy of regulatory CMC registered detail.
Champion business cases for changes and improvements related to manufacturing technology implementation or other strategic projects.
Accountable for facilitating Continued Process Verification (CPV) for products manufactured at the Rockville site.
Provide technical leadership to ensure rapid resolution of technical issues impacting supply through robust investigations, leveraging root cause analysis (RCA) tools and developing appropriate Corrective and Preventative Actions (CAPA).
Proactive Strategic Workforce Planning, including building MSAT succession plans and continuous capability build within the MSAT organization.
We are looking for professionals with these required skills to achieve our goals:
Bachelor of science in a scientific discipline.
At least 7 years’ experience in technology/biopharmaceutical process development.
At least 4 years prior experience leading groups involved in technology development and process transfer in a biopharmaceutical/ biotechnology manufacturing environment.
If you have the following characteristics, it would be a plus:
Strong working knowledge of GMP
Strong interpersonal and leadership skills. Committed team player prepared to work in and embrace a team-based culture.
Excellent judgment. Able to prioritize and decide appropriate courses of actions. Effective at implementing decisions. Proven track record of accomplishment.
Masters or PhD in appropriate scientific or technical discipline.
In-depth experience in biopharmaceutical technologies including large scale Cell Culture technologies, bioseparation technologies, and pharmaceutical manufacturing of proteins.
Strong technical understanding of industry and engineering/manufacturing practices related to the business.
Prior experience with biopharmaceutical product registration preferably with FDA and/or EMEA.
ICH Guidelines and FDA/EU validation practices for biopharmaceutical processes.
Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering, and operational disciplines.
Strong verbal and written communication skills which emphasize teamwork with a strong quality orientation.
#LI-GSK
Please 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 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.
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Website: https://gsk.com/
Headquarter Location: London, England, United Kingdom
Employee Count: 10001+
Year Founded: 1929
IPO Status: Public
Last Funding Type: Grant
Industries: Biotechnology ⋅ Health Care ⋅ Pharmaceutical