Critical Reagents Lead
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Sep 9 2021 The Critical Regeants Lead will maintain oversight of Biopharm critical reagents, reference standards to and from various GSK commercial manufacturing organizations or contract manufacturing testing labs. Support and manage as required the method life cycles associated with Control Standards, apply appropriate statistical tools to asses Control Standards capability, and develop method qualification/validation strategies consistent with ICH requirements and current regulatory expectations. The Critical Regeants Lead will support SOP and other quality document review/approval, business initiative/project management. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Administer the critical reagents/reference standard inventory program and support the effective transfer to and from sites. Assume responsibility for writing and reviewing SOPs, protocols, and other laboratory documentation as necessary. Work closely within and across interdepartmental matrix teams to ensure harmonization of work processes. Collaborate with GSK analytical development groups and serve as a liaison on inventory, technical issues with secondary customers. Work with QA, document control and validation groups to ensure quality standards are maintained and/or enhanced. As appropriate, be able to assume delegated duties associated with the Critical Reagents and Emerging Markets Group/ALM. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Biochemistry, Analytical Chemistry or related Science discipline and 2+ years of experience in the Biopharmaceutical industry OR 4+ years of experience in the Biopharmaceutical industry in lieu of Bachelor's Degree. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's Degree. Knowledge of protein Chemistry. Strong working knowledge in a biopharmaceutical quality control or development laboratory environment with experience in associated analytical methods (SDS-PAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay, USP/EP compendial testing). Working experience in method qualification, validation, technology transfer, and stability testing. Cold Chain distribution, inventory management, and other logistical experience are highly. Familiar with statistical trending. Strong Project Management skills. Strong technical writing abilities and in depth knowledge of cGMPs, biopharmaceutical manufacturing processes. Strong familiarity with FDA/EU/ICH and ROW regulations and guidance. Microsoft Windows experience required, with technical proficiency in Word, Excel, Empower, LIMS, and other laboratory IT systems typically used in the industry. Excellent written and verbal communication skills, ability to interact with both internal and external parties. Ability to work both independently and within a team environment. 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, rigour 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. 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. 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. 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