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Biopharmaceutical Stability Lead

King of Prussia, Pennsylvania
Closing date
Sep 21, 2021

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Site Name: USA - Pennsylvania - King of Prussia Posted Date: Aug 12 2021 Are you interested in contributing your detailed analytical knowledge of biopharmaceuticals while designing and managing the stability programs for biopharmaceutical projects in various phases of development ranging from Pre-Candidate Selection to Commercialization? If so, this Biopharmaceutical Stability Lead could be an ideal opportunity to explore. As a Biopharmaceutical Stability Lead, you will be proficient in authoring relevant CMC sections of regulatory submissions and have a strong understanding of statistical analysis as it pertains to stability data trending and product shelf-life applications. Key Responsibilities: Lead the design of biopharmaceutical stability strategies and implementation of stability work processes in-line with regulatory and business requirements Oversee external contract organizations with respect to stability testing and reporting Author and review stability protocols and reports Prepare analytical related content for relevant CMC sections of regulatory submissions Participate in agency meetings and inspections as the stability subject matter expert Participate and/or lead cross functional task forces when required to resolve specific technical issues Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS/MS with more than 5 years or a Ph.D. with 1 year of experience in biotechnology or pharmaceutical industry Biopharmaceutical development experience with a focus on formulation development, analytical method development, and release and stability testing Experience managing project matrix teams and cross-functional task forces Theoretical understanding of the analytical techniques currently used to release and characterize proteins and/or oligosaccharides Preferred Qualifications: If you have the following characteristics, it would be a plus: GMP experience Deep understanding of ICH guidelines and compendial requirements Hands-on experience in various protein separation, biological assays, and other characterization techniques such as CGE, cIEF, HPLC/UPLC, mass spectrometry, and functional assays Highly motivated and instinctive team player with excellent communication skills, both written and verbal 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. 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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