Senior Manufacturing Scientist

Job Description

Senior Manufacturing ScientistPermanentEdinburgh£35,000-£40,000Kelly Services, working with a global Biotech company are keen to speak with Senior Manufacturing Scientists to work at our clients site in Edinburgh. Reporting to the Laboratory Manufacturing Manager the post holder will be a highly motivated and experienced cell culture specialist supporting and delivering on the generation of our current products. The role is primarily laboratory based along with some supervisory aspects. This will involve the culture of human induced pluripotent stem cells, their differentiation to terminally derived specific cell type products, in conjunction with the manufacture ofassociated cell culture media reagents, all of which are a core part of the business. This will involve working in our well-equipped modern laboratories following our SOP controlled processes. The role will take on the responsibility for the organisation andexecution of the manufacturing master production schedule, as directed by the Laboratory Manufacturing Manager, and is a key member of the operations team, demonstrating excellent organisational skills combined with the ability to forward plan, assimilatescientific / technical knowledge and drive a Continuous Improvement/Right First-time culture. The incumbent will ideally have a minimum of 4 years experience, ideally, working in ISO or cGMP commercial laboratories and will show initiative and pro-activenessin their accountabilities. Areas of responsibility Liaise closely with Laboratory Manufacturing Manager in planning manufacture/production schedules and ensure that these are adhered to such that manufacture/production meets customer expectations. Liaise with Laboratory Manufacturing Manager in Capacity Tracking and staff assignment to workflow. Coordinating workflow with Laboratory Manufacturing Manager on all product manufacture or projects Work to current ISO 9001 (2015) standards, in terms of SOPs, manufacturing batch records and any required traceability, taking responsibility for all Quality Documentation relating to technical transfer and manufacturing of products and services using Q-Pulse QMS. Understanding KPIs for the manufacturing department to measure performance and aid continuous improvement ethos. Be able to develop and implement standard operating procedures (SOPs) to ensure consistent and compliant application of policies and programs throughout the laboratory. Engage in problem solving and root cause analysis sessions. Organise general lab/manufacturing duties (e.g., production, inventory of supplies, waste disposal, safety measures, cleaning) Use of Odoo ERP System relating to product manufacture and projects. Ensure compliance with Health & Safety standards (company policies, rules and regulations) Providing technical support to clients /customers if required Inventory Management, planning and purchasing of materials/ laboratory supplies to maintain constant production in specified timeframes working with Supply chain / Inventory colleagues. Some weekend work and travel between company sites will be required. Primary objectives

1. Work independently and efficiently to organise and perform high quality cell culture. To include generating, expanding, maintaining and banking cellular material in a timely fashion following approved SOP controlled processes ensuring that all productsmanufactured in house are of high quality and consistent across different batches.
2. Ensure that all laboratory work is accurately recorded in batch history records in sufficient detail such that it can be reproduced/repeated by another scientist.
3. Ensure that new products are correctly technically transferred from R & D to Operations
4. Tracking and management of saleable Inventory; establishing minimum stock levels, monitoring levels, linking in manufacture/production runs with expected demand.
5. Partake in and organise laboratory/equipment maintenance and cleaning as required.
6. Report any equipment failures to Laboratory Manufacturing Manager and assist with resolving the issues.
7. Assist with managing the day to day running of the lab.
8. Aid investigating NCRs & CAPAs to resolution. Required knowledge, skills, and abilities

The successful candidate will hold a BSc/MSc. in a biological science with 4-5 years of relevant post-graduation laboratory experience and have significant expertise in mammalian cell culture, ideally working in ISO or cGMP commercial laboratories. Possess excellent experience of maintaining and differentiating human induced pluripotent stem cells. Have a thorough knowledge of cell-based assays, immunocytochemistry, Flow analysis, sterility testing and PCR. Possess extensive experience with project management software tools, for example:- Q Pulse, ODOO. Ability to work independently. The candidate will have excellent verbal and written communication skills be Self-motivated, organised with excellent independent troubleshooting ability. Have a working knowledge of ISO 9001 and / or ISO 13485 Quality Management systems Additionally, the candidate should be efficient, proficient, and extremely well-organised (excellent time management is imperative) as well as comfortable working in a fast-paced team environment. Excellent communicator who takes a dynamic and pro-active approach to finding effective ways to achieve deliverables. Communication and people skills are key to the success of the department. The post holder must communicate widely with personnel at all levels within the Business, with suppliers and customers as required. The post holder is expected to engage in and promotepositive communication within the team and the company as whole. Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kellys Privacy Statement. For information regarding data protection at Kelly, please visit theKelly website and have a look into the Privacy Statement.As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.