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SalaryPosted Date: Mar 21 2024
External API Expert – 12 Months Fixed Term Contract
Closing Date for Applications – 4th April (COB)
This position is responsible for provision of a technically focused oversight of primary third party manufacturing on behalf of the Primary and Small Molecule and External Supply Franchises, including leading products moves in the external network, Root Cause Analysis, Technical Risk Assessments, supporting supplier selection, maintaining robust primary supply chain through proactive interventions, continuous improvement and technical management of proposed changes. The role will provide support and management of both API and intermediate manufactured products supplied into GSK sites & CDMOs on global basis.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
In this role you will:
- Delivery of technical projects.
Identification of opportunities for technical continuous improvement with third party processes, working with other functions in the PQTS+ Organisation to ensure projects are scoped, benefits assessed and project progress tracked to ensure successful delivery.
- Supplier Selection and Source Change.
Provide technical input into supplier selection process, reviewing supplier capability and assessment of risk, planning and delivery of Technology Transfers to new third party suppliers, understand the Procurement strategy of each material in own portfolio and input into the definition of this. Inputs technical details to registration documents.
- Troubleshooting and Issue Resolution.
Support Root Cause Analysis activity at third party suppliers as required, ensure that any troubleshooting issues are promptly resolved by ensuring relevant expertise is secured to manage the issue via appropriate use of technical knowledge, skills and with use of GPS tools as appropriate or through a request for resource from functional SMEs via the Third Party team Leader.
- Product Lifecycle Management.
Product owner for outsourced GSK IP APIs. Facilitation of technical risk activity with suppliers, identification or potential risks and working with suppliers to identify acceptable mitigation plans, review supplier process validation exercises and continued process verification data, ensures effective monitoring of performance management data from registered stages produced by third party manufacturers. Review of supplier technical change controls, working with other PQTS+ functions to ensure appropriate review and communication to stakeholders, customer sites and regulatory assessment as required.
- EHS Responsibilities.
Understand the EHS Systems documents and Operating Procedures relevant to job role. Ensure risk assessments, risk communication and action planning are completed in accordance with Risk Management System (RMS). Ensure that all incidents and accidents are reported to determine root cause and that any subsequent CAPA’s are closed out in a timely manner. Lead by example to demonstrate the right EHS behaviours and encourage others to improve safety culture. Be aware of personal safety and EHS guidance when present on a third party manufacturing site.
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- BSc, BPharm, BEng
- Technical knowledge depth/breadth in all aspects of API manufacture. Preferably a PhD / Post Graduate qualification in chemistry / process engineering, or a demonstrated track record in the Pharmaceutical Industry in a technical role.
- Extensive knowledge of chemistry & scale–up experience, with proven track record in delivering innovative, robust solutions in manufacturing.
- Substantial knowledge in API manufacture and experienced in Technology Transfer of chemical processes, working with R&D, with a proven track record in successful New Product Introduction (particularly for NPI activity) an advantage.
- Knowledge of current and emerging Regulatory advances (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9) for API and drug product manufacturing.
- Applicable knowledge of core secondary unit operations.
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- PhD or MEng / MSc / BSc
- Job requires high level of technical knowledge, ability to influence at all levels across GSC (Primary) sites, Global Technical, API & Mat Sci cluster, PD, Dose Form CoE’s and Network Strategy and high level of influencing of 3rd party personnel and sites.
- High degree of change and uncertainty, ability to work in virtual, cross functional teams, reporting to technical leads.
- Ability to matrix manage project teams remotely will be required.
- Role requires teamwork and engagement with other centres of excellence (& shared services), where required, such as Material Science and also External Supply, Procurement, Network Strategy, Quality, Safety and Engineering.
- High degree of flexibility in being able to travel to support appropriate Network priority, and able to work for periods away from home site.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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 neurodiversity, 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.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
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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