
Senior Scientist - Chromatography
- Göteborg
- Permanent
- Heltid
- Trains on routine operation, maintenance, and theory of complex analytical instrumentation, SOPs, and regulatory procedures and guidelines.
- Independently performs and gives guidance on a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing.
- Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs.
- Independently troubleshoots equipment & instruments. Mentors’ others in troubleshooting when applicable.
- Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria. Navigates the OOS/OOT/Atypical investigation process. Leads investigations and Root Cause Analysis and proposes CAPAs.
- Performs work assignments accurately, and in a timely and safe manner.
- Independently manages QC responsibilities. Communicates project status to project leader and helps to identify gaps and anticipates roadblocks in project team workflow.
- Coordinates laboratory activities of other team members in conjunction with the lab supervisor.
- Assists with the study design & protocol authoring. Leads data evaluation and study close-out.
- Independently completes QA facing tasks. Authors and leads more complex quality records (eg. quality records which may require more in-depth investigation to identify true root causes, quality records requiring cross-departmental input and/or collation of data etc.
- Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
- 5 + years previous experience that provides the knowledge, skills, and abilities to perform the job
- Subject matter expert in LCMS
- Experience within bioanalytics, chromatography services
- Technical capabilities with LCMS
- Intermediate knowledge of general chemistry and separation science
- Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
- Full knowledge of technical operating systems
- Ability to independently optimize analytical methods
- Ability to independently perform root cause analysis for method investigations
- Proven technical writing skills
- Proven problem solving and troubleshooting abilities
- Effective written and oral communication skills as well as presentation skills
- Time management and project management skills
- Ability to mentor others on technical operating systems
- Ability to independently review and understand project proposals/plans
- Ability to work in a collaborative work environment with a team
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.