Global QC Director - Biopharm
Site Name: UK - London - Brentford, USA - Pennsylvania - King of Prussia Posted Date: Jul 12 2021 Please note, this role is ideally based in our Upper Merion site (Pennsylvania, US) but we can also consider strong candidates at a range of international locations, including GSK offices and sites in the UK, US, Ireland and Europe. In this role, you will act as a key partner of GSK R&D, ensuring that Biopharm analytical methods developed for Pharma are fit for purpose. The position manages the Bioipharmaceutical analytical aspects of the product lifecycle, setting standards for Biopharm analytical testing in GSK, in collaboration with R&D. This means you will own the “big picture” for analytical testing, including design of transfer testing processes, approval of protocols, investigations, problem solving and improvements etc. to arm each analytical testing group, managed separately, with the best tools to support their own partners. Process change, standardisations and the like will also be applied to our external partners, requiring you to engage with the external network too. You will directly lead a team of around 4, with an indirect group of over 30, who themselves will contribute to submission writing, manage international transfers for in-state testing, and support the definition of specifications for products. As the leader, you oversee, develop and empower these individuals, but take personal responsibility for the greater analytical strategy for Pharma - working in partnership with R&D to define what this is and how it is delivered. This role is the overall lead for analytical large molecule in GSK Pharma. Your work will enable many international labs, contributing significantly to the analytical roadmap, digitalisation, future-proofing the organization, supporting launch of new products and the release of our critical portfolio. Through analytical success, you play a direct role in the success of GSK's product pipeline and the lives of the patients at the receiving end. Key Responsibilities include, but are not limited to: PSC Owner for Biopharm analytical standards and platforms, collaborating with R&D to ensure design intent is met and assays are fit for purpose (validation/integration/ robustness) Monitoring method robustness and acting as the decision maker post DG8 To Co-chair Specification board and Biopharm Analytical Governance Board you're your counterpart from R&D Overseeing (protocol preparation/acceptance criteria definition/project management) method transfers to internal and external nodes during lifecycle, as well as commercial stability and In-Country testing Connects & harmonizes with the Biolab network Commercial third-party oversight, ensuring each program has a Commercial Analytical Workstream Lead with lifecycle ownership for all analytical methods E2E network ops and strategy leadership including demand consolidation, supplier relationship management Leading PSC input into analytical technology roadmap, in collaboration with R&D, MSAT and PSC stakeholders Supporting sites, LOC testing facilities, External Biopharmaceutical testing providers in managing the analytical aspects of product lifecycle. Leading a team of analytical experts who work closely with R&D project teams to develop and ensure delivery of PSC requirements. To approve analytical sections of the BLAs / MAAs for biopharmaceutical product. Approval of comparability protocols. Post approval regulatory analytical writing and HA interactions About You: This role required collaborative working across many global partners in R&D and Manufacturing, as well as External suppliers to GSK. As such, the technical knowledge must be supported by fantastic people skills and the ability to develop and maintain positive relationships. This will require adept communication skills - such as knowing how to tailor and communicate sophisticated scientific information appropriate to your audience - as well as cultural sensitivity when working across international borders. You'll also be communicating up on many occasions, so the ability to influence senior stakeholders and to drive change through them is a must. This combination of knowledge and communications should combine into serious credibility, making you someone who is considered a company, if not industry, expert in Biopharma Analytical Techniques. CLOSING DATE for applications: Wednesday 21st July (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. Why You? Basic Qualifications: B.Sc Qualification in a Biochemistry, Biotechnology, Biochemical Engineering, Analytical Chemistry or related scientific discipline Minimum 10 years' experience in Biopharmaceutical, or Vaccine, analytical development Experience with a biopharmaceutical API's, mammalian and microbial processes Experience in Biopharm or Vaccine Quality Control Experience of Global GMP, Regulatory and Pharmacopoeia requirements Preferred Qualifications: M.Sc or PhD Qualification in a Biochemistry, Biotechnology, Biochemical Engineering, Analytical Chemistry or related scientific discipline Experience with Quality Control for commercial products Experience in both Development and Quality Control Experience of the product development process for Biopharm and Sterile therapeutic areas Why GSK? At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers. When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. 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