Senior Manager, Large Molecule Analytical Development
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, USA - Pennsylvania - King of Prussia Posted Date: Jul 30 2021 Are you looking for an opportunity where you will discover and develop chemical compounds or technologies? If so, this Analytical Chemistry Manager could be an ideal opportunity to explore. As part of the Medicinal Science and Technology (MST) response to the new R&D strategy and the acquisition of TESARO, an new enterprise has been created - Strategic External Development. This enterprise is a stand-alone development organization with the primary focus of developing GSK assets through an external network or providers. We are seeking an experienced manager/leader supporting development and registration of GSK's pipeline of preclinical and development-stage candidates. Develop analytical strategies for integrated early and late stage development activities in support of biologics commercialization. Will be a part of a team the person will lead is responsible for the generation of high-quality, on-time, and right-the-first-time data that comprise a critical component of regulatory submissions required to enable the clinical and/or commercial use of GSK products. The analytical data generated by these methods ultimately ensure the safe and effective use of our drug products in healthy volunteers and/or patients and ensure the continuity of supply of these drugs to patients. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Manage and oversee analytical activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. Execute the strategies for product characterization with a focus on CQA assessment, and lead characterization activities at CROs/CDMOs. Collaborate with process and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization. Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.). Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. Implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results. Partner with GMP/GDP Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high quality standards. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. or M.S. in chemistry, biology, biochemistry, or related technical discipline Minimum of 7 years (for Ph.D.) or 11 years (for M.S.) of biopharmaceutical analytical experience with recombinant biologic modalities and exposure to all stages of biologics drug development Significant experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment and process characterization for therapeutic proteins/mAbs is highly desirable Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization is expected, as well as a thorough knowledge of structure-function relationship of therapeutic proteins Approximately 10-15% domestic and international travel is anticipated Preferred Qualifications: If you have the following characteristics, it would be a plus: Ability to work in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities; must be able to work well in “gray space” Demonstrated experience and knowledge in tech transfer of methods and life cycle management Experience with oligonucleotides, antibody-drug conjugates (ADCs), bispecifics 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. 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