Drug Product Manufacturing Technician (Level III)
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A speciality biopharmaceutical company is currently seeking a Drug Product Manufacturing Technician (Level III) to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.
Job Responsibilities:
- Collaborate with the DPM Team Leaders and DP Manufacturing team ensure the requirements of the DP manufacturing schedule are achieved in a safe and cGMP/regulatory compliant manner.
- Establish and lead the manufacturing team to achieve the DP manufacturing schedule by engaging, motivating, and empowering them.
- Assist in the training of staff members, ensuring that Manufacturing Technicians are properly trained for their job functions and that the training is documented in a compliant manner.
- Act as an SME author/reviewer and/or approver for written procedures, SOPs etc., in span of expertise.
- Ensure the DP manufacturing suite and equipment are maintained in a state of Inspection readiness at all times.
- Training, coaching, and mentoring less experienced members of staff.
- Contribute to the smooth technical transfer of new processes/product into manufacturing.
- Identify process improvement and waste elimination opportunities to help create and maintain a lean, flexible, and agile manufacturing facility.
- Deputise for DPM Team Leader as required.
- Engage in pre- and post-production activities, including performing line clearances of the manufacturing areas.
- Clean and prepare areas for production, including equipment preparation using autoclaves, VPHP chamber, and washers.
- Oversee weighing and compounding activities, including the set-up of filters.
- Oversee aseptic manipulations outside the filling suites.
- Oversee the coding and labelling of vial and syringe products using the dedicated equipment.
- Monitor the environmental and building monitoring systems.
- Complete all batch related documentation, including forms and logbooks.
Skills and Requirements:
- BSc or Diploma in a Technical Discipline (e.g. pharmacy, biotechnology, biochemistry, engineering or a related field).
- Minimum of 5 years' experience in (bio)pharmaceuticals.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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