AD, QA Evaluations, Integrations, External Services
Kerr Dental
Google Cloud Platform
Director, Chromatography
Celerion
full-time
Posted on:
Location Type: Office
Location: Lincoln • New York • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Drive and lead development and implementation of regulatory-quality chromatographic methods to progress sponsor drug development programs
- Provide management, technical and scientific leadership to Method Development, Instrumentation and Bioanalytical Principal Investigator teams to foster collaboration and cohesive teams
- Conduct and measure performance evaluations through SMART goal setting and regular feedback to ensure high performance and equitable development opportunities
- Ensure the assigned laboratory meets planned revenue, operating margins, client timelines, quality and turnaround times
- Develop and implement strategic equipment and resourcing plans for the chromatography laboratory
- Ensure timely and scientifically robust development, validation and production of chromatographic methods to applicable regulatory standards and client expectations
- Facilitate and promote a proactive quality management culture of continuous improvement and operational efficiency, collaborating with global BAS and QA
- Ensure all work is performed according to GLP/GCP and EHS principles and controlled documents are followed
- Investigate potential growth opportunities with BAS Senior Management and increase Celerion’s presence in the bioanalytical community through collaborations, meetings, presentations and publications
- Support Business Development and Client Relations as a Subject Matter Expert in capability presentations, input to proposals, and pricing assumptions
- Participate in client and regulatory audits and support department leadership in driving customer satisfaction and relationship building
Requirements
- Ph.D. or M.Sc. degree in analytical or organic chemistry or related field
- Minimum of 10 years of related industry experience in regulated bioanalysis supporting nonclinical studies and clinical trials
- Deep understanding and hands-on experience of chromatographic principles, method development and analytical techniques in biological samples
- First-hand experience as a Study Director (SD), Principal Investigator (PI) or Bioanalytical Project Manager for regulated studies within a GLP/GCP compliant environment and experienced in Health Authority regulatory inspections
- Experienced in management, leadership and change management of large teams fostering team building, knowledge sharing and collaboration
- Knowledge of Laboratory Automation, Data Reduction Software (e.g. Analyst), and LIMS systems (e.g. Watson)
- Experience in utilizing scientific software systems and statistical tools
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
chromatographic methodsmethod developmentanalytical techniquesbioanalysisGLPGCPlaboratory automationdata reduction softwareLIMSstatistical tools
Soft skills
leadershipteam buildingcollaborationchange managementcommunicationperformance evaluationstrategic planningquality managementcustomer satisfactionrelationship building
Certifications
Ph.D.M.Sc.
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