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Downstream GMP Scientist/Operator
3 months ago
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Downstream GMP Scientist/Operator Apply locations Stevenage, United Kingdom time type Full time posted on Posted 2 Days Ago job requisition id JR1618Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.
We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together
Tasks and Responsibilities:
- Execute the delivery of GMP and engineering batches for customer gene therapy programs.
- Writing / adapting of relevant SOPs and documentation for specific DSP manufacturing operations and processes according to existing guidelines, including presentation of GMP operations processes and procedures in audits and inspections by regulatory authorities and customers.
- Responsible for completing production records to principles of ALCOA+ prior to quality review.
- Become competent in the operation of DSP equipment.
- Ensure timely completion of deviations, investigations and change controls and be able to lead investigations, identify root causes and propose SMART CAPAs.
- Act as a dedicated equipment owner, including trouble-shooting issues, ensuring equipment is serviced as per supplier agreements and remains in a validated state through periodic validation review.
- Liaise with Catapult regarding facility maintenance, upgrades, and training.
- Any other duties commensurate with the role and the above responsibilities.
What Is Important To Us:
- A degree (or equivalent) in a life sciences (or related) field.
- Sound knowledge of biotechnological processes & GMP manufacturing.
- A good understanding of the required industry standards for GMP manufacturing of investigational medicinal products.
- Experience in working within production for the manufacture of ATMPs is highly desirable but not essential.
- Experience of single use manufacturing and pilot scale or large-scale bioprocessing equipment.
What We Offer:
- Employment in a company that offers real added value and manufactures medicines for seriously ill patients.
- To be part of the ATMP growth and success story, participating in the development of a great company culture based on teamwork, empowerment and opportunity for personal growth.
- A holiday entitlement of 28 days plus public holidays.
- Flexible working conditions
- An above market pension provision increasing with length of service.
- Private medical health care and benefits scheme.
- Plus other additional benefits.
