Manager, Analytical Development - Oligonucleotide

Nombre del sítio: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Fecha de publicación: Aug 11 2022 Are you looking for an impactful role that leverages your technical expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Manager, Analytical Development role in a rapidly growing, empowered, innovative and agile Strategic External Development organization developing transformative medicines within a vibrant GSK hub could be an ideal opportunity to explore. As a Manager, Analytical Development, you will contribute to internal and external development of the company's specialty drug products and/or development of SED’s internal processes. We are seeking an experienced manager/SME 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 new product commercialization. Will be a part of a team 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, NDA, 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: M.S. in chemistry, biology, biochemistry, or related technical discipline 5 years experience in biopharmaceutical analytical development with small molecule, oligonucleotide, mRNA, monoclonal antibody and/or antibody-drug conjugate modalities and exposure to all stages of drug development Experience with analytical method development, validation and transfer Experience in the biopharmaceutical industry with relevant experience in late stage product, CQA assessment Approximately 10-15% domestic and international travel is anticipated Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD in chemistry, biology, biochemistry, or related technical discipline 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” Theoretical and hands-on knowledge and experience with characterization methodologies for drug substance and drug product Demonstrated experience and knowledge in tech transfer of methods and life cycle management Experience with antibody-drug conjugates (ADCs), bispecifics Why GSK? Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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