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Senior Scientist - Process Validation Biopharmaceutical Process Development

Rockville, MD
Closing date
Dec 10, 2021
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Site Name: USA - Maryland - Rockville Posted Date: Dec 8 2021 GSK currently has an opening for a Senior Scientist for the Process Validation Biopharmaceutical Process Development in Rockville, MD. In this role, you will be involved in all aspects of the development of purification processes for therapeutic proteins including initial process screening, optimization and characterization, validation, scale-up and tech transfer to clinical manufacturing and/or commercial manufacturing partners Key Responsibilities: Understand scope and timeline of required validation activities for individual projects. Participate in defining the scope, sampling and acceptance criteria for validation protocols. Write process validation protocols. Coordinate sampling for PV needs and submission of samples for analytical testing Compile, analyze, communicate validation results; identify and troubleshoot problems or protocol deviations Describe validation results in the form of written validation reports and presentations Work seamlessly within cross-functional and BPT teams Understand process validation needs is support of regulatory filing Provides SME support for process validation activities Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS degree in Chemical Engineering, Biochemistry, Chemistry or Biology. Over 4 years biopharmaceutical industry experience. Preferred Qualifications: If you have the following characteristics, it would be a plus: M.S. degree in Chemical Engineering, Biochemistry, Chemistry or Biology and over 2 years of biopharmaceutical industry experience. Basic knowledge or some experience in cell culture, protein purification or analytical testing and working knowledge of routine laboratory procedures and/or plant equipment/operations. Ability to compile and analyze data and communicate findings. Proven experience with technical writing, excellent verbal and written communication skills. Desire to coordinate team activities working with the aggressive timelines. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness *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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