Senior Director Drug Substance & Product Analysis UK

Site Name: UK - Hertfordshire - Ware RD, Stevenage Posted Date: Feb 10 2023 Are you interested in a highly visible leadership role, leading a UK based Analytical Chemistry function to provide analytical project delivery across drug substance and drug product of key new assets from our innovative portfolio? If so, the Senior Director position is an exciting opportunity to explore. The role will lead a group of approximately 130 employees comprised of Directors, Team Leaders and Scientists accountable for the development, use and validation of robust analytical methodology and associated specifications for API and DP across our Stevenage and Ware R&D Sites. The role will be accountable for the provision high quality scientific contribution to enable portfolio progression from early to late phase project development including regulatory documentation (Phase 1 to NDA/MAA/JNDA etc.), technical transfer of commercial methodology to GSC and establishment of appropriate clinical and commercial specifications for our small molecule portfolio (including oligonucleotides, oral solid dose and inhaled products). The holder will be responsible for analytical method development and in-depth characterization of all early Biopharm assets within Biopharm Process Research, enabling early process research workflows including cell line development, upstream and downstream processes as well as formulation and stability studies. The Senior Director will provide leadership to the department, including the development of scientific capability in core areas ensuring resource flexibility across drug substance, drug product and across modalities. Key Responsibilities: Provide leadership, guidance, and strategic direction to a group of analytical chemists on all aspects of analysis for all projects residing within the group. Embrace inclusion and diversity to create and modern and dynamic working environment across the department. Ensure efficient and top-notch development, utilization, and transfer (into GSC or external supplier(s)) of high-quality and optimized analytical methods, and associated specifications for drug substances and/or drug products that meet or exceed the expectations of internal partners and external regulators and that ensure the high and consistent quality and performance of drug substances and/or products. Ensure the right-the-first-time analytical testing of drug substances and/or drug products that allow for the on-time release of drug substances and/or drug products by Quality Assurance for clinical use. Provide high quality analytical data to enable cell line development and early process research workflows for our large molecule portfolio prior to transfer to first GMP manufacture Ensure that technical excellence is maintained within the group and that staff are developed to their fullest potentials by providing coaching, mentoring, and appropriate learning opportunities for staff. Ensure that the group is fully integrated into CMC DDA ambitions Working with all partners across MDS, CMC Regulatory Affairs, and GSC, the department director will ensure on-time delivery of high-quality CMC packages for submissions that meet or exceed the expectations of external regulators and that lead to first-cycle approvals. Implement a continuous improvement plan to ensure that activities performed by the group are in compliance with current regulatory expectations in the markets of interest and are at the leading edge of analytical sciences. Ensure the work conducted by the group is performed in accordance with GSK and external regulatory standards in the markets of interest and is also conducted in accordance with GSK and local EH&S standards. Basic Qualifications/Experience Bachelor of Science in Life Sciences or relevant area Extensive experience with the Pharmaceutical Industry of CMC small molecule drug development of drug substance and oral solid dose products Proven ability to effectively lead a group of analytical or pharmaceutical scientists with extensive scientific knowledge in in the application of analytical techniques to the development of small molecule drug substance and drug products with demonstrated experience in specification setting and selection of analytical methods and a proven track record of regulatory writing and approvals Experience of non-regulated, GLP and GMP processes necessary to develop a medicine ready for commercial release and supply to the clinic with a strong understanding of product development disciplines and relationship of analytical testing to drug development A highly effective leader with demonstrated effective interpersonal, communications, influencing, and negotiation skills across internal and external (e.g. GSC) stakeholders and partner groups with an ability to effectively handle and appropriately escalate issues based on risk in a timely manner, a problem solver, innovative, creative with operational delivery solutions who thrives in a fast-paced environment with potential for significant change and the courage to make tough decisions to enable accelerated product development An ability to effectively coach and mentor group members promoting continuous professional development amongst all staff and seeking out opportunities for staff to further their knowledge and experience Digitally savvy with an ability to drive digital transformation changes to accelerate product development. Preferred Qualifications Experience of the development of multiple modalities e.g. mAbs, bispecific antibodies, oligonucleotides and ADCs Experience of sterile drug product development and inhaled product development *LI-GSK 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. 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