Senior Manager, Chemical Development

Click to know more about GSK Biopharm #GSKBiopharm_Development Are you looking to expand your expertise with scientific technology in a global environment that allows you to keep pace with the speed of change? At GSK, we are transforming how new scientific technologies are used to improve patient's lives. The Senior Manager, Chemical Development will be responsible for the development, optimization, implementation, and management of robust, cost effective, and safe processes for the manufacture of small molecules including Oligonucleotide Active Pharmaceutical Ingredients (APIs). The incumbent will be responsible for the technical development, support, validation and commercialization of drug substances using an external and internal network of providers. This position is integral to the advancement of GSK's growing portfolio of drug candidates and technology programs. The scope of the role encompasses a wide breadth of lifecycle, ranging from early stage development, late stage development, process validation to commercial manufacturing. S/he will be expected to manage these activities using an outsourcing model and to work within a cross-functional team environment of external service providers and internal team members to help define project scope and plan, and ensure successful delivery with regards to process development, technical troubleshooting, quality, compliance, milestone timelines and project budget. The successful candidate will report directly to the Director, Chemical Development. Job Responsibilities Provide support of Active Pharmaceutical Ingredients (API) development programs. The candidate will identify opportunities and activities that can enable the scale up of drug candidates for pre-clinical and clinical studies as well as supporting validation activities when progressing to late stage. Collaborate and coordinates in cross-functional teams, both internally and at CROs (contract research organizations) to develop robust, scalable, cost effective and safe chemical processes. Responsible for timely deliveries of drug substance to support IND/IMPD enabling toxicology studies as well as manufacture of phase-appropriate cGMP API to support clinical studies. To develop and optimize safe and scalable chemical processes for the manufacturing of drug substance. Recommends the development of economical, state-of-the-art techniques to synthesize, purify, isolate and characterize drug substance by keeping up to date with the scientific literature, regulatory guidelines and industry advances Troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate. Construct and manage experiments to screen, optimize, and scale chromatographic and synthetic chemistry processes. Ensure the work conducted by external partners and the group is performed in accordance with GSK and external regulatory and quality standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards Preparation of technology transfer packages to support technical transfer activities between GSK and supplier, or between suppliers and support of technical audits. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD in synthetic organic chemistry with 5+ years of experience in pharmaceutical research and development in the biotech or pharma industry, with experience in the areas of process development, process characterization, process validation and product life cycle management OR BS/MS with 8+ years' industry experience. Experience working in a virtual CMC development with External Vendors, CMOs/CROs Ability to travel ~ 30% both domestically and internationally. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong collaboration and communication skills; ability to build and maintain good working relationships with internal and external stakeholders.Ability to apply organic chemistry to designing and developing new synthetic routes In depth knowledge of oligonucleotide chemistry including potential routes of impurity formation and the ability to develop processes to oligonucleotide drug targets Practical experience of laboratory and /or plant scale oligonucleotide synthesis, purification and isolation Fundamental understanding of the role of ADCs (Antibody Drug Conjugates) in the biopharmaceutical industry, with knowledge of the technical challenges of development and manufacture Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions. Desire to acquire new knowledge in chemistry and biopharmaceutical science Experience with control strategy development by either process characterization or design space studies using DoE or modelling tools. Experience in collaborations with medicinal chemistry, analytical, biology, toxicology, clinical pharmacology, Quality Assurance, Regulatory CMC and CMC development departments. Experience in preparation of CMC documents in support of global regulatory filings across development stages (e.g. IND to NDA and IMPD to MMA). Why GSK? Uniting science, talent, and technology to get ahead of disease together At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *This is a job description to aide in the job posting, but does not include all job evaluation details. *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. At GSK, the health and safety of our employees are of paramount importance. 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