Title:
QC Microbiologist 2
Company:
Ipsen Biopharm Ltd
Job Description:
We are currently recruiting for a QC Microbiologist 2 to join our Microbiology team. This position is a fixed term contract (FTC) for twelve months. The successful candidate will be working on a “4 on, 4 off” shift pattern, as part of a team of six, involving days and based at our Wrexham site in North Wales, reporting to the QC Microbiology Process Leader.
Ipsen is a rapidly growing global biopharmaceutical company focused on innovation and specialty care with sales growth of 21.1% in 2021. Ipsen aim to make a sustainable difference by significantly improving patients’ health and quality of life through differentiated and innovative medicines in oncology, neurosciences and rare diseases.
At Ipsen Wrexham, we focus on neurosciences and support ‘end to end’ Biopharmaceutical Development from Discovery, through Development, to Commercial Manufacture, a unique breadth within the UK.
The successful applicant will have thorough working knowledge of US/EU cGMPs, Aseptic techniques and Gowning. Can identify and communicate non-compliances and actively suggest solutions and drive new initiatives. Promote accuracy and precision in daily laboratory practices whilst adhering to relevant SOP’s and standards (safety, environmental, GLP and regulatory), and highlight and correct discrepancies with minimal supervision.
Main Duties & Responsibilities
The QC Microbiologist 2 will be actively involved in all aspects of microbiological testing and be conversant with GLP, GMP and regulatory requirements. Review and approve batch documentation and associated OOS’s. Fully contribute to investigational work and actively compile and execute project work.
Your role will also include:
Perform environmental Monitoring of Clean Rooms and controlled environments in accordance with current testing schedules and manufacturing activities.
Perform microbiological testing of raw materials, in-process and final product for microbial contamination within required time frames.
Provide training in all key microbiological methodologies.
Review and execute validation studies and project work.
Review and report test results within company lead times. Responsible for completion of batch data and all associated OOS/OOT and UE records for designated batches.
To be considered for this role, you will ideally have a degree in Microbiology or equivalent in a Biological Science subject. Relevant experience in a microbiology laboratory within a pharmaceutical company is ideal along with supervisory experience.
We are looking for candidates who have the following key technical competencies:
Aseptic Technique.
Aseptic Gowning.
Training curricula / job specific training modules will be performed as per the Site Training Procedure 060023-SOP.
Thorough working knowledge of US/EU cGMPs as applied to Biopharmaceutical testing and their practical application.
Experience of working in a matrix organization.
If you think this sounds like the right opportunity for you then don’t wait, apply today and become part of the team improving the lives of patients globally!
#LIOnsite
To all agencies: please no phone calls or emails to any employee of Ipsen in relation to this opening. All resumes submitted by search firms/employment agencies to any employee at Ipsen via email or any form of communication/method will be deemed the sole property of Ipsen, unless such search firms/employment agencies were engaged by Ipsen for this position and a valid agreement with Ipsen is in place. In the event a candidate who was submitted outside of the Ipsen agency engagement process is hired, no fee or payment of any kind will be paid.
IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.