
Sr Group Leader - R&D Bioanalytics
- Göteborg
- Permanent
- Heltid
- Reviews and approves study protocols, project status reports, final study reports and other project related technical documents.
- Allocates, schedules and manages laboratory resources for group's project activities and updates project status and revenue projections. Reviews timesheet reports for billing accuracy.
- Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits.
- Responds to clients questions and needs; leads client technical meetings.
- Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget.
- Identifies new opportunities within client base and ability to work with business development to pursue opportunities.
- Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.
- Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.
- Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs.
- Regularly communicates to staff quality related issues and items for staff
- Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar
- 2 + years management experience
- 8 + years previous experience that provides the knowledge, skills, and abilities to perform the job
- Experience within bioanalytics, immunochemistry, chromatography services
- Technical capabilities with LCMS, ligand binding techniques
- Ability to train and mentor junior staff
- Ability to cultivate a collaborative work environment with a team and across business areas
- Effective written and oral communication skills as well as presentation skills
- Proven problem solving and troubleshooting abilities
- Understanding of basic financial terms and definitions as it applies to the business
- Ability to independently develop project proposals/plans
- Project and time management skills
- Proven ability to identify and implement common efficiencies across multiple programs/projects
- Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs
- Proven ability to cope with a dynamic work environment
- 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.