What are the responsibilities and job description for the Senior Director Immunoassay position at Resolian?
Responsibilities
Manage performance and professional development of staff
Oversight and leadership of multiple managers, departments, or sites as appropriate
Guide and make decisions on scientific, operational, and regulatory issues, as appropriate
Perform tasks on a site or global level
Implement programs and drive process improvement to assure financial and budget expectations are met
Establish department objectives
Track revenue and assist with financial planning and budgeting
Develop capabilities and resources to meet present and future needs
Develop and execute strategic plans to meet business growth objectives
Support Business Development in development of new and existing clients
Establish Key Performance Indicators to identify opportunities for improvement
Participate in client and regulatory audits as required
Implement programs and drive process improvement
Oversee staff recruitment, training, and progression
Ensure employee adherence to regulatory compliance for data integrity and assigned SOPs
Other tasks as assigned
Skills, Education & Qualifications
Ph.D. degree in biology or related major, with 10 years' of working experience in bioanalytical CROs or bioanalysis in a pharmaceutical or biotechnology company.
Strong scientific knowledge of bioanalysis of biomarker, ADA, Nab and PK using LBA technologies.Knowledge of PCR and flowcytometry technology is a plus
Strong knowledge and understanding of regulatory requirements; GLP, GDP, GCP, 21CFR Part 11.
Excellent knowledge and understanding of the pharmaceutical industry.
Extensive experience in managing / conducting studies to support projects.
Excellent communication skills (writing and speaking).
Extensive experience in ELN and LIMS.
Able to lead, mentor, inspire and develop scientific staff.Ability to set and lead strategy for growing a group.
Able to guide trouble shooting for problematic projects (method development, validation and sample analysis) with the team.
Able to develop and implement research strategies and align with organizational goals.
Able to foster scientific excellence and build scientific reputation internally and externally.
Ability to identify opportunities and respond quickly to client requests and expectations.
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