Extractables and Leachables Risk Assessor, Open to flexible working

Stevenage, Hertfordshire
28 Apr 2021
16 May 2021
Contract Type

Exciting opportunity for an enthusiastic individual to join a trace analysis and extractable and leachable (E&L) team in an industry leading bio pharmaceutical company.

The successful candidate will primarily undertake E&L focussed risk assessments using Failure Mode and Effects Analysis (FMEA) to provide key information in support of the company's diverse development portfolio of medicinal products. The successful candidate will work with a high level of autonomy and contribute to analytical projects (from initial risk assessments through to final report) as well as inputting into the development of trace level control strategies for individual projects, contributing to regulatory submissions and overseeing completion of work packages placed at CROs. T he successful candidate must be a high calibre graduate or a PhD with at least 5 years' experience performing FMEA based risk assessments with a knowledge of the biopharmaceutical industry .

Primary responsibilities include:

  • Conducting and documentation of FMEA risk assessments for biopharmaceutical drug substance and drug product manufacturing processes, container closure systems and dosing devices.
  • Identification and design of technical work packages to support risk mitigation activities
  • Authoring of technical documentation
  • Project management and contribution to regulatory submissions

Key requirements:

  • BSc or PhD in Chemistry , Materials Science or related field
  • Strong communication, project management and interpersonal skills
  • Ability to work independently and problem solve with a track record of generating high quality data and reports
  • Previous experience conducting FMEA risk assessments

Additional skills:

  • Development of trace level control strategies for individual projects
  • Understanding of analytical chemistry , in particular, the control of trace level extractables and leachables
  • Knowledge of biopharmaceutical single use systems

Company Details:

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.

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.