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Manager — Biopharmaceutical Manufacturing Sciences

Rockville, MD
Closing date
Jan 27, 2022

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Life Sciences, Biochemistry, Other, Manufacturing/QA/QC
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Site Name: USA - Maryland - Rockville Posted Date: Jan 7 2022 GSK is currently looking for a Manager in our Biopharmaceutical Manufacturing Sciences Department to join our team in Rockville, MD. In this role, you'll manage certain elements (such as upstream/downstream etc.) of the transfer of primary(drug substance) biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organizations to Pharma Supply Chain (PSC) Biopharm to other biopharmaceutical manufacturing sites. Support delivery of new biopharmaceutical applications and technologies as well as on delivering improvements to the existing supply chains supported by Biopharm and technology transfers between Biopharm & R&D. Also, you'll Support efforts to continuously reduce product COGS while improving product quality for products supplied by GMS Biopharm. Key Responsibilities: Support the introduction and possible scale-up of primary (drug substance) processes transferred from R&D or third-party clients for specific products new within GMS Biopharm. Support establishing resource requirements necessary to implement approved projects. Act as technical Biopharm representative on the technology transfer teams and product development project team for specific products. Responsible for managing the relationship between R&D or third-party clients and Biopharm for specific products and if needed influence decision makers within R&D or third-party clients. Provide technical oversight of manufacturing operations or coordinating technical activities for specific products at Third Party sites for GMS Biopharm. Provide manufacturing technical floor support and help make decision/troubleshoot when issues arise Propose strategies and priorities in planning technical transfer/process validation/process improvement activities within area of expertise. Responsible for process trend analysis and assurance that processes remain within control parameters. Responsible for resolving process issues/ problems in a manner and timeframe consistent with production and quality goals for specific products. Provide technical training to production staff for new equipment and process technologies as required. Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and near-term process improvements within area of expertise. Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated in GMS Biopharm and that related regulatory documents to support licensing of specific products are prepared. Contribute to evaluations of potential fit of prospective new products into GMS Biopharm (e.g. SIA's RFI responses) Design lab experiments as needed and interpret complex data/results. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/BA in either biological or chemical science or engineering or equivalent technical discipline. Experience with current GMP's practices for biopharmaceutical processes Preferred Qualifications: If you have the following characteristics, it would be a plus: A minimum of 5 years post-graduate experience in the Biopharmaceutical/pharmaceutical industry or equivalent with significant emphases on technology development and/or process technology transfer. Preferably has at least 2 years of experience in the development of biopharmaceutical drug substance manufacturing processes. Expert knowledge in biopharmaceutical technologies including large scale cell culture/microbial technology, biopseparations technologies, and pharmaceutical manufacturing of proteins. Understanding of analytical technologies related to the above. Strong interpersonal and leadership skills. Strong verbal and written communication skills. Strong Analytical and critical thinking skills. Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. Able to provide leadership to generate options to resolve problems, prioritize, and decide appropriate courses of actions. Effective at implementing decisions. Committed team player prepared to work in and embrace a team-based culture. Leadership potential. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.
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