Global QC Director - Biopharm
Site Name: UK - London - Brentford, USA - Pennsylvania - King of Prussia Posted Date: Jun 4 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: Sunday 20th June (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. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.