KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Downstream Processing Expert will be varied however the key duties and responsibilities are as follows:
1. You will drive implementation of effective purification strategies and technologies; from new drug candidate selection, to pre-clinical (pharmacology & toxicology), clinical development, transfer to Manufacturing, and commercial product manufacture.
2. Support effective DoE for process design/optimisation, implementation of appropriate control strategies (QbD) in co-ordination with analytical and process development requirements. Support implementation of appropriate life-cycle strategies, process validation and regulatory documentation to support product development plans, briefing documents and CMC documentation, as required, to ensure successful regulatory approvals.
3. Lead from the bench by implementing new ways of working to increase throughput while maintaining data integrity and traceability.
4. Support indirect (matrix) staff management as required, leading and developing people (through role model behaviours, training, mentoring and coaching); building functional capability & expertise, technical skills & know-how; helping to motivate and empower Bioprocess team staff to perform their roles.
To be successful in your application to this exciting opportunity as the Downstream Processing Expert we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific discipline with relevant and extensive Biopharmaceutical R&D industry experience in purification process development.
2. Proven Biopharmaceutical industry experience in developing purification processes ideally using AKTA or UF/DF
3. A working knowledge and practical experience with regulatory / quality aspects associated to Biopharmaceutical production is highly desirable.
Key Words: DSP | Process Development | GMP | Downstream | DoE | QbD | Purification | AKTA | TFF | UF / DF | Protein | Antibody | Biopharmaceutical | Biotechnology | Pharmaceutical |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.
Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.Report this job