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Investigator - Analytical Lifecycle Management (ALM)

King of Prussia, Pennsylvania
Closing date
Jan 21, 2022

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Site Name: USA - Pennsylvania - King of Prussia, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Dec 21 2021 As Investigator, Analytical Lifecycle Management, you will be responsible for building and enhancing biopharmaceutical expertise to be further embedded in the business. This role will provide YOU the opportunity to lead key activities to progress your career. These responsibilities include some of the following... Contribute to the implementation of business processes and best working practices to ensure Analytical Lifecycle Management operates strategically and as efficiently as possible. Independently authors internal reports, protocols, policies/plans or regulatory submissions. Supports department objectives in alignment with project objectives. Anticipates and recognizes potential problems, initiates actions to solve or prevent problems and communicates issues/risks to project lead and manager. Contribute to the successful and timely transfer, validation and oversight of BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer's, testing labs, or GSK commercial manufacturing organizations (Product Supply Chain). Effectively prioritizes activities to meet project or department objectives using demonstrable project management skills. May lead a project, matrix team or small focus groups. Plays a significant part in the project team decision making process. Consistently exhibits professionalism and courtesy and may serve as a representative of GSK to business partners and contract organizations. Presents effectively to internal R&D and PSC forums and may present results at external meetings. Keeps manager and matrix team leaders informed of progress and activities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Biochemistry, Chemistry, Biology, or Science-related field with 5+ years of Analytical Technology Transfer and Validation experience OR a Ph.D./MS degree in Biochemistry, Chemistry, Biology or Science-related field with 3+ years Analytical Technology Transfer and Validation experience. Preferred Qualifications: If you have the following characteristics, it would be a plus: Thorough knowledge of cGMP requirements. Previous experience in Analytical Technology Transfer and Validation for biopharmaceuticals. Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Transfer and Validation, Critical Quality Attributes, and Release and Stability Testing. Independently applies knowledge in area of specialization to assignments that involve multiple decision points. Familiar with GLP regulations. Previous Biopharmaceutical experience Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest 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. 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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