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). Please note that this role may require working a 16/5 shift pattern.
This role will be responsible for supporting activities related to the three sub-groups operating within the ADL CAS team as outlined below:
- Analytical Support activities involving Analytical Method Troubleshooting, Analytical Method Lifecycle (Method Development, Qualification, Validation, Remediation) and Analytical support for Process Development (PD) activities at the site.
- Forensics & Defects activities involving forensic identification of Drug Product defects and maintain and produce extensive defect panels used to support automated and manual visual inspection of vial (liquid / lyophilised) and syringe packaged drug products.
- International Analytical Support activities involving analytical method transfers to external parties and supporting shipment of critical reagents and standards to global partners.
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.
Key Responsibilities:
- Analytical method troubleshooting, qualification, validation, bridging, transfer.
- 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.
- Plan and implement procedures and systems to maximise operating efficiency.
- 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:
- 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.