Reports to: Director, Analytical Sciences
Direct Reports: 4-6
MAIN PURPOSE OF JOB
We are seeking a highly motivated and experienced analytical development scientist to join our Chemistry, Manufacturing and Controls (CMC) organisation. You will lead the development and establishment of release, stability, and characterisation assays to support our exosome product pipeline including the development of new assay platforms. You will have experience in the qualification/validation of a broad range of assays for biotherapeutic products according to ICHQ2 guidelines to ensure the quality, safety, and efficacy of these products. We are looking for an individual with a desire to continue to work ‘hands-on’ in the laboratory whilst leading a team of development scientists delivering all aspects of analytical development activities from the development and refinement of Analytical Target Profiles (ATP’s) through to establishment of robust assays in support of the analytical control strategy, qualification/validation, IND/IMPD/CTA filing and ultimately successful MAA/BLA filings.
We are looking for an individual who will thrive in a agile environment, be able to lead, motivate, and innovate and relish the sense of accomplishment each day brings in our exciting and growing company.
- Lead and further develop a team of analytical development scientists as well as developing analytical methods ‘hands-on’.
- Support method lifecycle activities for analytical methods including pre-qualification, assay transfer, design of validation studies, designing assay maintenance programs, and developing assay controls and trending programs.
- Proactively drive improvements in Quality within the Analytical Development group and ensure adherence to Quality processes.
- Work collaboratively with wider analytical development groups to jointly establish effective analytical capabilities and processes, including cross-training between groups for efficient working.
- To work collaboratively with Research, Cell Line Development, Process Development, Translational and Clinical departments to develop and establish new techniques and recommend alternative approaches and potential solutions to analytical issues.
- Provide analytical support to Research teams, Cell Line Development, Process development and pre-clinical manufacturing.
- Oversight of external CMC analytical activities at CRO’s and CMO’s.
- Deliver analytical development reports ensuring timely completion and quality of documentation.
- Ensure a healthy and safe working environment and compliance to COSHH, GMO/ACDP requirements.
Education and Qualifications:
• PhD or BSc/MSc in Chemistry, Biochemistry, Biotechnology, Food Science, Biological or a related field.
A highly motivated ambitious senior scientist with:
- Ability to work independently and lead others.
- Good conceptual, analytical thinking, problem solving, and organisational skills.
- Ability to work in a high paced team environment, meet deadlines, and prioritise work from multiple projects.
- Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
- Ability to balance multiple priorities and projects at the same time and be able to change priorities as needed by the business.
Experience & knowledge
- Direct industrial laboratory experience in biologics and/or cell/viral product bioanalytical development following PhD or 8+ years direct industrial laboratory experience as above following BSc/MSc.
- The candidate will have broad experience in developing a broad range of assays to measure content, purity and impurities of biologics in order to ensure quality, efficacy and safety for patients.
- Experience in the development for assay and purity of gene-based products.
- The ideal candidate will also have experience in generating, interpreting and mining “omics” datasets such as proteomics, genomics and glycomics.
- Experience in bringing and applying new technologies suitable for assay development such as immunoassay platforms, electrophoresis, U/HPLC, imaging.
- Experience in developing, transferring, qualifying, validating methods in a regulated environment.
- Sound understanding of regulatory agency guidance associated with analytical methods for biologics and assay qualification/validation.
- Working knowledge in utilising statistical approaches such as design of experiments (DoE) in developing potency assays to identify sources of assay variability, developing operating ranges within an assay procedure to ensure minimum assay variability.
KEY BEHAVIOURAL ATTRIBUTES – ALL STAFF
People with Purpose – We are innovative and creative in the way we work and deliver. We treat each other with respect and dignity and work collaboratively to learn from each other’s strengths.
Driven to Deliver – We strive to deliver our objectives, and then look for our next challenge. We recognise our achievements and celebrate our successes.
Agile and Accountable – We respond to challenges impacting our progress and find creative and innovative solutions to overcome obstacles. We are brave and not afraid to change our approach to achieve a positive outcome in optimum time.
Candid and Constructive – We communicate with honesty and transparency throughout the team. We value giving and receiving constructive feedback to each other and our partners.