- Direct the science and business involved in the conduct, direction, and execution of Immunoanalytical operations and studies including PK, ADA, and biomarker quantification. Contribute expertise in the development, validation/qualification, and troubleshooting of these assays, and subsequent management of sample analysis in support of nonclinical and clinical trials.
- Provide oversight and guidance to staff in the conduct of these activities.
- Fluency in current regulatory requirements and expectations is required, and familiarity with data management using Watson LIMS is desirable.
- Contribute to new business development and cross-site activities in support of Immunoanalytical services.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Direct and oversee department activities to ensure achievement of department objectives.
- Provide senior level review of protocols, reports and related documents for appropriate scientific content and interpretation in collaboration with other senior staff.
- Oversee and ensure report timelines are maintained and perform quality assessments to ensure high quality study design and timely reporting.
- Interact with Sponsors, consultants and other outside contacts; interact with government representatives and Sponsors when site visits are conducted.
- Identify key regulatory requirements and guidelines that pertain to preclinical and clinical testing and specialty services that we provide.
- Identify and implement new scientific initiatives and capabilities.
- Promote and facilitate new business development. Evaluate opportunities and recommend other technologies that may be established.
- Ensure departmental policies, practices and procedures adhere to GLP/FDA regulations as they relate to the conduct of preclinical studies. Establish new policies and practices to ensure compliance with all applicable regulations and corporate policies.
- Ensure coordination of study bids, study design and conduct, protocol review, consultant interactions, staffing needs, analysis, and reporting of Laboratory Sciences studies.
- Represent the organization to industry groups, key customers, representatives of government and regulatory agencies and the general public.
- Ensure a positive employee relations position is maintained and that effective communication is maintained to inform employees of plans and progress.
- Anticipate problems and initiate improvements.
- Maintain up-to-date knowledge of current industry practices.
- Contribute to recruitment of scientists.
- Interview and select qualified exempt-level departmental personnel. Recommend, review and approve personnel actions, including hiring, promotions and raises. Partner with Human Resources in the handling of disciplinary issues. Prepare and/or approve appropriate personnel action paperwork.
- Ensure that management training and development needs are identified and programs initiated. Direct the development of departmental orientation and other training programs.
- Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews. Review and approve performance and salary appraisals initiated by direct reports.
- Monitor and determine appropriate levels of departmental overtime. Review and approve vacation/time off requests for direct reports.
- Develop short- and long-range operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel.
- Develop and recommend departmental budget. Authorize expenditures in accordance with budget. Approve budget and expenses of subordinates.
- Ensure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.
- Direct the development and communication of departmental systems, SOPs, policies and procedures. Partner with Human Resources to develop and approve departmental job descriptions; ensure communication of duties and responsibilities to employees.
- Develop business leads to ensure the company’s financial success.
- Train and mentor scientific staff.
- Perform testing facility management duties for the site as delegated by senior management.
- Perform all other related duties as assigned.
Education: Masters Degree in immunology, biochemistry or a related scientific discipline required. PhD preferred.
- 7 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical environment, working to Good Laboratory Practice (GLP) standards. 5 years management experience, including staff management and development, and financial responsibility including budgets.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute.
- Management and problem solving skills. Demonstrated abilities in analytical, quantitative and critical thinking.
- Ability to handle multiple projects, meet deadlines and make executive level decisions.
- Detail oriented, flexible with the ability to work well in a team-oriented environment.
- Proven ability to work in a dynamic, deadline driven environment.
- Proficient project management, presentation, and communication skills.
- Proficient with computers and standard application software.
- Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
- Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to accurately exchange accurate information in these situations.
- Must occasionally move about inside the office to access file cabinets, office machinery, etc.
- General office working conditions, the noise level in the work environment is usually quiet.
- While performing the duties of this job, the employee will occasionally be required to enter the laboratory and/or vivarium and would be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), and/or work near live animals with risk of exposure to allergens and/or zoonotic diseases. The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.
This position will require occasional travel.
Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet