Director, Chromatography

Director, Chromatography

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to get innovative medicines to market faster and help patients as quickly as possible. Our world-leading bioanalytical labs have been supporting pharmaceutical and biotech companies around the world for more than 50 years.

Due to steady and sustainable expansion, we are looking for a full-time Director, Chromatography based on-site in Lincoln, Nebraska, USA. In this role you will play a crucial role in driving and leading the development and implementation of regulatory quality chromatographic methods to progress sponsor drug developments programs. If you are passionate about using your bioanalytical expertise and leadership to improve patients lives then we would love for you to join our dynamic team.

This role will focus on providing management, including technical and scientific leadership, to the Method Development, Instrumentation and Bioanalytical Principal investigator teams to foster collaborative and cohesive teams while promoting and nurturing a culture of collaboration, integrity and respect. Also, the role will conduct and measure performance evaluations, through SMART goal setting and regular feedback to team members ensuring high performance, productivity and equitable development opportunities.

This role is responsible for ensuring that the assigned laboratory meets its planned revenue and operating margins and client timelines, including quality and turnaround times

The role will develop and implement strategic, equipment and resourcing plans for the chromatography laboratory. Also, 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 efficiency of operations, working collaboratively with the global Bioanalytical Services (BAS) Division and other stakeholders such as QA. This role will ensure all work is performed according to GLP / GCP and EHS principles and local and global controlled documents are followed.

The role will work with BAS Senior Management team to investigate potential growth opportunities for the company. In addition, increase Celerions presence in the Bioanalytical community through collaborations, active involvement in meetings and industry consortia and by presenting at scientific meetings and author scientific publications in peer reviewed journals.

In relation to Business Development and Client Relations, this role will support BAS Leadership in driving new business to meet the department and company objectives; act as a Subject Matter Expert (SME), supporting Business Development in client capability presentations as required; and provide input and feedback on new opportunities and provide key assumptions to price proposals.

This role will have a robust understanding of the business and regulatory directions and trends related to the bioanalytical industry and provide value-added solutions / suggestions to the client. Additional responsibilities will include participating in client and regulatory audits, and supporting the department leadership in driving customer satisfaction and relationship building

Requirements

• Ph.D. or M.Sc. degree in analytical or organic chemistry or related field with a minimum of 10 years of related industry experience in regulated bioanalysis supporting nonclinical studies and clinical trials
• Possess a 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) required
• Experience in utilizing scientific software systems and statistical tools

Celerion Values : Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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