Analytical Engineer

About the role

You'll join BioLamina's Quality Control department and plan and perform analytical testing of our development samples and support quality control with testing of our finished products. Your results support process development and product release. Our quality management system is certified to ISO 9001:2015, and we're working toward higher quality standards.

What you'll do

• Plan analytical testing and perform routine and non-routine testing of development samples, bulk and finished products against approved operational instructions, specifications and SOPs, mainly with ELISA-based methods.
• Run supporting methods as needed: functionality testing, SDS-PAGE, Western blot, protein concentration measurement (such as A280) and HPLC.

• Perform analytical method development and execute method transfer and validation experiments according to approved protocols.
• Record, review and report results following good documentation practice (GDP) and data integrity principles

• Report deviations and OOS results, and lead investigations, root cause analysis and troubleshooting.
• Write and update SOPs, methods and forms, and train and supervise analysts.

• Maintain, calibrate and check lab equipment
• Participate in internal and external audits.

• Follow and maintain the lab's health and safety rules, including risk assessments.

Requirements

• A master's degree (or equivalent) in Biomedicine, Biomedical Laboratory Science, Biotechnology or a related field
• Hands-on experience with ELISA, SDS-PAGE, protein concentration

• Experience with analytical method development, transfer or validation
• Fluent English, spoken and written

• Good computer skills, including MS Office and an eQMS

Meriting:

• Experience with QC work in a GMP- or ISO-regulated setting and familiarity with ISO 9001 and GDP
• Experience with Western blot, HPLC, cell culture

Personal qualities

As a person you are precise, structured and detail-oriented, able to work on your own and in a team and able to handle several tasks at once and meet deadlines. You are comfortable guiding and supervising colleagues, and you are a clear communicator who looks for solutions and better ways of working

Why BioLamina?

You'll join a growing, international life science company whose products help bring new treatments closer to patients. Our values – Respect, Excellence, Accountability, Collaboration and Heart – guide how we work together.