Commercial Attribute Sciences - Senior Associate

Berkley Group; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Berkley Group Ireland is seeking a Senior Associate in Commercial Attribute Sciences (CAS) within Process Development to join our Dublin site. The role covers forensic investigation of defects in drug product manufacture, maintenance of defect panels, and cross‑functional support to Attribute Sciences programs.

The successful candidate will document analytical data, assure data integrity, comply with SOPs, and contribute to regulatory readiness. Eligibility to work in Ireland/EU is required.

Qualifications

• Hold a third level qualification (Degree) in Analytical Chemistry/ Biochemistry or related discipline.
• 3-6 years of experience in the Pharmaceutical Industry.
• 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.

Responsibilities

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture at company 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 characterization of automated / semi-automated / manual finished drug product visual inspection equipment.
• Act as support for the Attribute Sciences function on cross functional teams/programs
• Timely documentation of Analytical data in the electronic notebook system.
• Understanding 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.

Skills

Analytical chemistry

Biochemistry

Communication skills

Regulatory inspections experience

Team collaboration

Problem-solving tools

Analytical method development/validate

Change control/variation management

Statistical tools/multivariate分析

Education

Bachelor's degree in Analytical Chemistry or Biochemistry or related

Job description

Global Biotechnology company based in south Dublin, Ireland - looking for Commercial Attribute Sciences - Senior Associate. This job specification outlines the general responsibilities associated with the role of Senior Associate within the Commercial Attribute Science (CAS) Dept. of Process Development at company site.

The role

• Leads / assists forensic investigation and identification of defects arising from drug product manufacture at company 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 characterization of automated / semi-automated / manual finished drug product visual inspection equipment.
• Act as support for the Attribute Sciences function on cross functional teams/programs
• Timely documentation of Analytical data in the electronic notebook system.
• Understanding 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.

Have You:

• 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.
• 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.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.