My client is a leading pharmaceutical company focusing on developing live biotherapeutic products from the human gut microbiome. So far, my client has two clinical stage programmes in IBS and IBD as well as a strong pipeline of pre-clinical programmes in autoimmunity, inflammation, oncology and CNS disease.
Due to recent expansion, my client is looking for a programme scientist to help provide subject matter expertise to help bridge the gap between pre-clinical to regulatory by providing scientific support to the manufacturing, clinical and regulatory teams. Report writing, and presentation skills play a key part with this role as there will be meetings held with numerous stakeholders related to the business.
Experience / Qualifications Required
• Bachelor’s degree in microbiology, biological sciences or related discipline
• At least 2 years’ experience working in biological sciences or on microbiome derived products
• Expertise in scientific programmes from preclinical to product development
• Excellent report writing skills
• Excellent communication skills and ability to work well within a team
Key Areas of Responsibility
• Provide scientific support to the manufacturing, clinical and regulatory teams, bridging the gap between pre-clinical to regulatory in providing scientific knowledge of the product;
• Understand the needs of regulatory, clinical, manufacturing and research regarding candidate strains to co-ordinate activities between the departments;
• Support the drafting of regulatory documents with scientific input pertaining to the candidate strain(s) such as Investigator’s Brochure and IMPD with the team;
• Provide scientific knowledge regarding the candidate strain(s) at key meetings, Scientific Advice meetings with the regulators, meetings with clinical CRO’s, clinical Site Initiation Visits;
• Provide scientific expertise in product development activities, such as antibiotic resistance testing, media, bacteria specific knowledge, preclinical studies;
• Collection, analysis and presentation of scientific information pertaining to the products;