Scientist, Cell and Gene Therapy – (on-site Stevenage, UK

Submission for the position: Scientist, Cell and Gene Therapy – (on-site Stevenage, UK - (Job Number: 169910)PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

PPD has an exciting opportunity to join us onsite at one of our clients in Stevenage, Hertfordshire as part of our innovative Functional Service Provider (FSP) programme, as an employee with PPD.

You will be dedicated to the client projects, working within their teams, systems and processes on behalf of PPD.

The role of this Analytical Support Analyst/Scientist is to contribute to the QC and analytical development laboratory, providing routine analytical support for both process development and manufacturing of cell and gene therapy products.

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit http://www.ppdi.com/.

Key responsibilities:

• Analytical testing to support clinical manufacturing, as well as process and analytical development activities.

• Support laboratory and equipment maintenance

• Facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory, and responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures.

• Executes and write up scientific experiments in a timely manner and with high quality

• Maintain detailed laboratory records in accordance with GMP

• Support training of colleagues in QC and Product Development

• Review and compilation of results

• Performing work assignments accurately, timely and in a safe manner

• Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines

• Participate in the validation of test methods and equipment used in analysis to meet regulatory requirements

PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success.

PPD has an exciting opportunity to join us onsite at one of our clients in Stevenage, Hertfordshire as part of our innovative Functional Service Provider (FSP) programme, as an employee with PPD.

You will be dedicated to the client projects, working within their teams, systems and processes on behalf of PPD.

The role of this Analytical Support Analyst/Scientist is to contribute to the QC and analytical development laboratory, providing routine analytical support for both process development and manufacturing of cell and gene therapy products.

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit http://www.ppdi.com/.

Key responsibilities:

• Analytical testing to support clinical manufacturing, as well as process and analytical development activities.

• Support laboratory and equipment maintenance

• Facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory, and responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures.

• Executes and write up scientific experiments in a timely manner and with high quality

• Maintain detailed laboratory records in accordance with GMP

• Support training of colleagues in QC and Product Development

• Review and compilation of results

• Performing work assignments accurately, timely and in a safe manner

• Training on routine operation, maintenance and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines

• Participate in the validation of test methods and equipment used in analysis to meet regulatory requirements

Basic Requirements

• BSc in biology, cell biology, virology, biochemistry or related scientific discipline or a HNC/HND will also be considered• Experience in one or more of the following: Immunoassays (ELISA), Molecular(e.g qPCR, ddPCR) and/or Biological assays(e.g cell based assays, Flow cytometry)• Strong organizational and excellent interpersonal communication skills• Individual should be capable of writing reports related to work completed in laboratory.• Demonstrated excellence in technical writing skills• Demonstrable ability to work in multi-disciplinary, multi-cultural team• 2-4 years of analytical testing experience in an industrial setting

Preferred Requirements• Experience in analytical testing in support of recombinant viral vector production, stem cell and T-cell therapies• Experience in assays that measure infectious and physical viral titre, cell counting and viability, immunophenotyping of cells, and/or determination of process residuals (e.g. host cell proteins).• Experience in vaccines, biopharmaceutical, or cell and gene therapy product or analytical development• Experience in a GMP or GxP regulated environment• Experience in authoring and revising SOP’s, Guidelines, and Reports

What we offer:PPD offers a benefits package that includes among others, a comprehensive health plan, retirement plans, and other incentives. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves!

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Basic Requirements

• BSc in biology, cell biology, virology, biochemistry or related scientific discipline or a HNC/HND will also be considered• Experience in one or more of the following: Immunoassays (ELISA), Molecular(e.g qPCR, ddPCR) and/or Biological assays(e.g cell based assays, Flow cytometry)• Strong organizational and excellent interpersonal communication skills• Individual should be capable of writing reports related to work completed in laboratory.• Demonstrated excellence in technical writing skills• Demonstrable ability to work in multi-disciplinary, multi-cultural team• 2-4 years of analytical testing experience in an industrial setting

Preferred Requirements• Experience in analytical testing in support of recombinant viral vector production, stem cell and T-cell therapies• Experience in assays that measure infectious and physical viral titre, cell counting and viability, immunophenotyping of cells, and/or determination of process residuals (e.g. host cell proteins).• Experience in vaccines, biopharmaceutical, or cell and gene therapy product or analytical development• Experience in a GMP or GxP regulated environment• Experience in authoring and revising SOP’s, Guidelines, and Reports

What we offer:PPD offers a benefits package that includes among others, a comprehensive health plan, retirement plans, and other incentives. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves!

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Submission for the position: Scientist, Cell and Gene Therapy – (on-site Stevenage, UK - (Job Number: 169910)