Senior QC Associate - Bioanalytical Lab Lead

Amgen Inc.; Dublin; On-site; EUR 53,000 - 71,000; Full time

Job summary

Amgen Inc. is seeking a QC Senior Associate for the QC Bioanalytical Sciences laboratory at the Amgen Manufacturing site. You will lead, coordinate, and support lab operations and compliance with minimal supervision, driving continuous improvement and Right First Time (RFT).

The role represents QC with internal and external customers and may include additional duties as required. You will work with Cell-Based Potency Bioassays, Immunoassays, and Cell Culture, plan complex methods, review data,

Qualifications

• Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
• Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
• Strong background in Cell-Based Potency Bioassays, Immunoassays and Cell Culture is essential.
• Excellent written and verbal communication skills.
• Experience leading cross-functional teams.
• Knowledge of applicable Regulatory requirements.
• Experience working with Regulatory inspections and interaction with inspectors is preferable.

Responsibilities

• Experience in a wide variety of analytical techniques including but not limited to Cell-Based Potency Bioassays, Immunoassays, Cell Culture and Aseptic Technique.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• Participate in the peer review of analytical data.
• Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
• Lead training of staff on technical aspects of job as required.
• Develop, revise and implement procedures that comply with appropriate regulatory requirements.
• Qualification of analytical equipment and related testing functions.
• Participate in Analytical Method Transfers Compliance with SOPs and Registered specifications.
• Ensure the laboratory is operated in a safe manner.
• Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
• Ensure timely completion of Laboratory Investigations and Deviations.

Skills

Excellent written and verbal\n-?

Experience leading cross-functional\n-

Problem solving methods

Planning/organisation

Teamwork and collaboration

Coaching and motivating

Education

Bachelor's degree in Biology, Biotechnology or related discipline

Tools

Regulatory knowledge tools

Job description

Amgen Inc. is seeking a QC Senior Associate for the QC Bioanalytical Sciences laboratory at the Amgen Manufacturing site. You will lead, coordinate, and support lab operations and compliance with minimal supervision, driving continuous improvement and Right First Time (RFT).

The role represents QC with internal and external customers and may include additional duties as required. You will work with Cell-Based Potency Bioassays, Immunoassays, and Cell Culture, plan complex methods, review data,