Sr. Manager, Large Molecule Analytical Development
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Sep 15 2021 We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us!Click to know more about GSK Biopharm. #GSKBiopharm_Development Sr. Manager, Large Molecule Analytical Development 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: 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 Approximately 10-15% domestic and international travel is anticipated. Preferred Qualifications: 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. 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. 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. Managing P&L and capital allocation *LI-GSK gskbiopharm_development 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). 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