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Director, Immunoanalytical - United States  

Company managed [?] Still accepting applications

Posted on : 31 March 2017

Project Description

BASIC SUMMARY:
  • 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.


Qualifications
Education:  Masters Degree in immunology, biochemistry or a related scientific discipline required. PhD preferred.
Experience:  
  • 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.

 
Other: 
  •  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.


PHYSICAL DEMANDS:
  • 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.


WORK ENVIRONMENT:
  • 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.


COMMENTS:
This position will require occasional travel.


Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet