External Manufacturing Investigator, Open to flexible working
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
The External Supply Investigator (ESI) is responsible for managing the relationship with the external partners manufacturing Cell and Gene therapy products for GSK, ensuring adherence to the contract terms while maintaining a positive relationship with the partner. The ESI is also responsible for implementing relationship-specific KPls and monitoring performance against them.
Key Responsibilities include, but are not limited to:
- Managing activities and/or services provided by external suppliers/contractors, including support of negotiation of timelines, costs, and deliverables for such work packages
- Develops relationships with internal partners and external suppliers whilst maintaining the highest level of professional and ethical conduct
- Significant external influencing required ensuring alignment of GSK business requirements with supplier's expectations. Ensures protection of GSK IP in all Supplier interactions
- Influences organizational thinking and/or research and development activities by leveraging their scientific or technological expertise
- Provide person in plant support for key activities at external partners
- Leads joint teams with external parties tasked with manufacture and testing/release of CGT products
- Effectively communicates across extended matrix teams comprising CGT, QA, Program/ Project Teams/ GSK Procurement organizations, and external supplier organizations
- Contributes to global outsourcing policies and third-party oversight for CGT / R&D
- Participates in performance reviews of preferred suppliers. Coordinates, manages & reports Key Performance Indicators (Performance measures) on a regular basis
- Proactively defines and implements CGT CMC and sourcing plans, critically evaluating these against business requirements to ensure project objectives are met
- Develops contingency plans and proposes alternative strategies as appropriate
- May be required to provide direct oversight of development/ cGMP activities and may support due diligence activities with some travel required
- Initiates and implements continuous improvements in ways of working
- Responsible for monitoring the integrity and quality of partner derived data ensuring it is suitable to support robust manufacturing/ testing and associated GSK regulatory filings
- Reviews and approves 3rd party investigations and change control
- Provides technical advice and interfaces with development group when needed for troubleshooting
Closing Date for Applications: Friday 7th May 2021
Please take a copy of the Job Description, as this will not be available post closure of the advert.
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.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors of Science or Engineering
- Reasonable experience in a GMP setting
- Experience in Leading, Writing and Reviewing Investigations and Change Controls
If you have the following characteristics, it would be a plus:
- Masters Degree in Science or Engineering
- Experience in GMP manufacturing setting
- Cell processing and or cell culture experience
- Understanding of Bioassays such as cell count, viability, and flow assays
- Project Management Experience
- Contract negotiations with 3rd Parties
- Prior 3rd party oversight experience
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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