Associate Director/Sr Manager, Large Molecule Analytical Development

Waltham, Massachusetts
Aug 30, 2021
Sep 26, 2021
Jobseeker Type
Organization Type
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 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 wxperienced 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… Leading analytical workstream to develop analytical plans to support clinical product development, product life-cycle management and regulatory submissions, including developing and implementing justifiable strategies and release/stability criteria for various scenarios including accelerated product development. Support all CMC filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs and track analytical development /QC commitments. Participate in BLA-enabling activities including product and process characterization, comparability studies, CQA assessment activities; assist in review of regulatory filings in INDs/IMPDs, CTAs and BLAs and ensure that CMC-related changes are reported in accordance with regulatory requirements. Collabrate efficiently with cross functional MPD team members to ensure on-time delivery of major milestones. Facilitate tech transfer of methods to QC testing facility, commercial QC groups and to CMO's. Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. Participate in CRO/CDMO selection, management and auditing, as needed. Establish and 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: Master's or Bachelor's degree with extensive relevant industry experience. Minimum of 10 years 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 and process characterization for therapeutic proteins/mAbs. Significant experience with methods used for biopharmaceutical characterization is expected, as well as a thorough knowledge of structure-function relationship of therapeutic proteins. Demonstrated experience and knowledge in tech transfer of methods and life cycle management. Preferred Qualifications: If you have the following characteristics, it would be a plus: Ph.D. in analytical chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical. Bioassay experience In-depth understanding of bioassay development Experience leading cross-functional teams Experience working with external vendors 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 Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *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). 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. 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