Job Description
As a Senior Scientist, you will play a crucial role in leading the development, deployment, and improvement of validation processes within the Quality Control department to ensure maximum performance levels and compliance are maintained.
Position Summary:
The purpose of this position is to serve as a subject matter expert in our Quality Control department, recognized as an industry expert. The candidate will ensure equipment is maintained in a validated state, meeting cGMP requirements.
Responsibilities:
* Lead the team in introducing, validating, and executing methods.
* Review analytical method validations and transfers, write technical protocols, and reports.
* Review and trend data.
* Investigate deviations and address them.
* Supervise assigned tasks and projects.
* Train QC staff.
* Analyze and optimize current lab/business processes in laboratories, supporting implementation activities of technologies and methodologies.
* Assist with scheduling and prioritizing laboratory testing.
* Act as a delegate for the AD of QC Analytical or Microbiology if required.
* C coach and mentor team members, helping with problem-solving and skill development.
* Identify improvements and make recommendations as part of a team to ensure continuous improvement.
* Assist with preparation for internal/customer/regulatory inspections.
* Recruit team members in line with resource requirements and job specifications.
Health, Safety, and the Environment:
* Comply with all EHS policies and procedures.
Quality Compliance:
* Comply with all quality policies and procedures.
Production:
* Provide technical knowledge and support.
* Participate in risk assessments as a Subject Matter Expert (SME).
Qualifications and Skills Required:
* BSC or MSc in biological sciences.
* Minimum 5 years industrial/laboratory experience in GMP Analytical Laboratory.
* Demonstrated ability to introduce, validate, and optimize methods.
* Experience working in cross-functional teams.
* Analyze and optimize current lab/business processes in laboratories, supporting implementation activities of technologies and methodologies.
* Experience with analytical testing using Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, Mass Spectrometry, or other large molecule characterization techniques.
* Knowledge of Analytical Methodologies and sound scientific understanding of Critical Quality Attributes, data analysis, and statistics for setting specifications.
* Team player with peer-to-peer coaching abilities.
* Proficient in Microsoft Office.
* Professional, proactive demeanor.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.