Commercial Attribute Sciences – Associate Scientist (Shift Role)

Amgen Inc; Ireland; On-site; EUR 45,000 - 65,000; Full time

Job summary

A leading pharmaceutical company in Ireland seeks an Associate Scientist to join the Commercial Attribute Sciences team. This role focuses on customer complaint analysis, forensic investigations, and ensuring compliance with quality standards. Ideal candidates will have 3-6 years of experience in the pharmaceutical industry and a degree in Analytical Chemistry or a related field. Excellent communication skills and the ability to work in a team-oriented environment are essential. This is a shift role requiring adaptability and attention to detail.

Qualifications

• Minimum 3-6 years of experience in the Pharmaceutical Industry.
• Knowledge of Data Integrity principles and Quality compliance.
• Experience with Regulatory inspections and interactions.

Responsibilities

• Support customer complaint analysis for drug product samples.
• Lead forensic investigations and document findings to cGMP standards.
• Maintain and distribute defect panels for visual inspection training.
• Participate in internal/external audits/inspections.

Skills

Forensic analysis skills

Excellent written and verbal communication

Problem-solving tools/techniques

Team collaboration

Education

Degree in Analytical Chemistry/Biochemistry or related discipline

Tools

Optical Stereomicroscopes

Job description

Commercial Attribute Sciences – Associate Scientist (Shift Role) page is loaded## Commercial Attribute Sciences – Associate Scientist (Shift Role)remote type: On Sitelocations: Ireland - Dun Laoghairetime type: Full timeposted on: Posted Todayjob requisition id: R-232619## **Career Category**Process Development## ## **Job Description**This job specification outlines the general responsibilities associated with the role of Associate Scientist within the Commercial Attribute Science (CAS) Dept. of Process Development at Amgen Dun Laoghaire (ADL). This role will be responsible for primarily supporting activities related to customer complaint analysis as well as other activities associated with the Forensics and Defects function within the ADL CAS team as outlined below:* Customer Complaint analysis involves Return Unit Inspection, Primary Packaging Evaluation, Secondary packaging evaluation for customer complaint Drug Product samples.* Forensics & Defects activities involving forensic identification of Drug Product defects and also maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.The successful candidate will have proven experience acquired in the Pharmaceutical Industry, have a right first-time mindset, be a team player, have excellent communication skills and be focussed on delivering on our customer needs. The successful candidate will also have a strong understanding of Data Integrity principles, Quality and Compliance in the laboratory as well as good presentation/influencing skills. Additionally, the role may involve carrying out additional work functions that are not described in this specification but are associated with their role.***Please note this role is a shift role with a 16/5 shift pattern.*****Key Responsibilities:*** Customer complaint analysis for DP samples.* Leads / assists forensic investigation and identification of defects arising from drug product manufacture at ADL and write up of these investigations to cGMP standards.* Be accountable for the maintenance, distribution and upkeep of extensive defect panels used for the set-up, training and characterisation of automated / semi-automated / manual finished drug product visual inspection equipment at ADL.* Act as support for the Attribute Sciences function on cross functional teams/programs* Timely documentation of Analytical data in the electronic notebook system.* Understanding of data flow in laboratory systems and data integrity.* Participate in the peer review of analytical data.* Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory.* Ensure the laboratory is operated in a safe and environmentally friendly manner.* Ensure ongoing compliance with phase appropriate GMP, including compliance within the LMS training system.* Ensure high levels of Laboratory housekeeping are maintained including inventory control of samples and consumables.* Ensure timely completion of Laboratory Investigations, Deviations , PMAFs* Participate in internal/external audits/inspections as required.* Manage and contribute to the achievements of department productivity and goals.* Engage with the Continuous Improvement Process and MyGreenLab philosophy.**Qualifications:*** Hold, at a minimum a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.* Have 3-6 years of experience in the Pharmaceutical Industry**Knowledge and Experience:*** Forensic analysis skills including use of Optical Stereomicroscopes* Excellent written and verbal communication skills* Experience with Regulatory inspections and interaction with inspectors is preferable.* Experience working with teams and influencing decisions.* Skilled in the use of problem-solving tools/techniques* Experience with developing, validating, troubleshooting, analytical methods.* Understanding of the Change Control and Variation Management Process* Understanding how the use of statistical tools, such as multivariate analysis can aid troubleshooting.* Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating..