Associate Research Scientist, Fsp

4 weeks ago

Stevenage, United Kingdom Thermo Fisher Scientific Full time

Who is PPD?

PPD is a leading global contract research organization. Our _purpose_ is to improve health. Our _mission_ is to help customers deliver life-changing therapies. Our _strategy_ is to bend the cost and time curve of drug development and optimize value for our customers.
- PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine._

The PPD FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. _We_ deploy the same top-tier talent in ALL engagement models_. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

PPD is currently looking to recruit an Associate Research Scientist to be based on-site at one of our clients in Stevenage, Hertfordshire as part of contracted work from PPD.

The role of the Associate Research Scientist is to work in their Analytical Development Department within the Cell and Gene Therapy Therapeutic area to support the development of suitable analytical methods that can support both process development and manufacturing of cell and gene therapy products

Key responsibilities:

- cGMP analytical support, tech transfer, validation, execution of analytical methods, verification, etc
- Coordinate with FSP group leader and client manager to select, design,and execute experiments
- Effective decision making to achieve desired outcomes of project team through technical or scientific interpretation of results
- Deep technical understanding of the field of interest
- Preparation of oral or written reports to influence strategic decisions
- Ensuring scientific accuracy and excellence
- Communication and engagement through presentations and publications
- Making significant contributions to ensure project/program/platform milestones are achieved
- Proactively seeks solutions for problem solving across teams/departments
- Working and leading within matrix teams
- Maintain awareness of current regulatory considerations for medicinal products
- Ensure safe working environment
- Utilize project management tools to monitor, drive, and report KPIs on team progress in both analytical development and quality control.

Basic Requirements:

- BSc in biology, cell biology, virology, biochemistry or related scientific discipline or a HNC/HND will also be considered
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6+ year) or equivalent combination of education, training, & experience.
- Experience in bioanalytical testing
- Strong organisational and excellent interpersonal communication skills
- Demonstrated excellence in technical writing skills
- Demonstrable ability to work in multi-disciplinary, multi-cultural teams
- Strong GMP background, working in QC environment - ideal
- Ability to work independently with a pro-active approach
- Mammalian cell culture, both primary and cell lines
- Cell isolation, characterization, manipulation and expansion
- Virology
- Vectorology
- Molecular Biology
- Computational biology/bioinformatics
- Vector and cell Formulation
- Upstream processing
- Downstream procession
- CAR-T/TCR processing
- Stem cell processing
- Analytical Development
- Regulatory Documentation
- QbD
- Tech Transfer
- MPD workstream lead
- Proven problem solving and troubleshooting abilities
- Time management and project management skills
- Good written and oral communication skills
- Ability to work in a collaborative work environment with a team
- Ability to train junior staff

Preferred Requirements
- MSc in biology, cell biology, virology, biochemistry or related scientific discipline or a HNC/HND will also be considered
- Experience in tissue culture and flow cytometry
- Experience in qPCR, ddPCR, and immunoassays (e.g. ELISA)
- 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 determination of process residuals (e.g. host cell proteins).
- Experience in qPCR, ddPCR, flow cytometry and immunoassays (e.g. ELISA)
- Experience in primary, stem cell and T-cell culture and transduction with lentivirus.
- Experience of vaccines, biopharmaceutical or cell and gene therapy product development

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