The Director of Laboratory Operations is responsible for a US Laboratory facility and operation of this laboratory, in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Director plans of 1988 (CLIA), and applicable Takeda and BioLife policies, procedures and quality initiatives. The Director of Laboratory Operations plans and directs activities of the screening and pooling laboratories by performing the following duties personally or through subordinate managers and supervisors.
1.Plans, coordinates, and directs programs for the testing of BioLife and contract centers source plasma.
2.Ensures that systems are in place to assure product quality.
3.Establishes and oversees quality control functions to insure accuracy and appropriate product and sample testing is performed, completed, and reported in a timely manner. Reviews testing, quality control, and other operational reports to ensure that quality standards, efficiency, and schedules are met.
4.Establish and implement laboratory training programs, which assess knowledge, skills, and abilities, as well as job performance and competency.
5.Participates in the annual budgeting process and operates the laboratory within budgetary guidelines.
6.Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance.
7.Negotiates with outside vendors to ensure appropriate volume discounts, unit pricing, product quality and suitability, and service.
8.Provides technical direction and expertise to new BioLife projects or product lines requiring laboratory support and evaluation.
9.Advise management, quality assurance, regulatory, and technical personnel of laboratory activities.
10.Prepares reports and technical papers.
11.Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence
12.Provides leadership in problem identification, investigation, and resolution.
13.Directly supervises laboratory operations managers, oversees supervision of general laboratory supervisor, area coordinators, and laboratory staff.
14.Works in conjunction with BioLife Quality Assurance Senior Management team in the implementation, monitoring, and maintenance of the laboratory quality systems.
15.Interviews, hires, and oversees performance of laboratory staff.
16.Ensures that proper training is received and documented.
17.Oversees the document control system to ensure that:
Laboratory procedures are reviewed to provide correct and timely distribution.
Document control SOPs are followed.
Annual review of SOPs is performed and changes are implemented in a timely manner.
All procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operation requirements and guidelines, SOP manuals contain current versions of procedures and manufacturer inserts.
Obsolete documents are properly removed from use and archived.
All other duties as assigned.
EDUCATION AND EXPERIENCE
Minimum Degree Required:Â
Bachelor's degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology).
Preferred Degree: Â Â
Bachelor's degree or higher from an accredited college/university in medical technology.
MT/MLT certification preferred
Familiarity with regulated disciplines in a laboratory setting or a pharmaceutical manufacturing/industry environment.
Minimum Ten years experience in a professional or technical capacity in laboratory services or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
8-10 years management experience required.
KNOWLEDGE, SKILLS AND ABILITY:
Strong written and verbal communication skills.
Attention to detail and organizational skills.
Ability to manage a departmental budget.
Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
Ability to adapt to changing priorities.
Walking, standing, observing others performing work assignments.Â
Ability to work in an office / production environment.Â
Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.
USA - GA - Social Circle - Baxter Pkwy
Internal Number: R0031619
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.