Testing Laboratory Opportunities

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Job Description

About Us:

Every day, our BioLife Testing Laboratories’ mission is to ensure the highest quality testing standards for the plasma we collect. The plasma our centers collect will become life-changing medicines for patients in need. Here, a commitment to lab testing quality, customer service to our centers and most importantly our commitment to our patients is expected.

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

What Takeda can offer you:

Takeda offers 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. 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.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.

The Director, Operations is responsible for the BTL-US facilities and operation of the laboratory at the facilities, 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 Operations plans and directs activities of the screening and pooling laboratories by performing the following duties personally or through subordinate managers and supervisors.

ACCOUNTABILITIES

• Plans, coordinates, and directs programs for the testing of BioLife and contract centers source plasma.

• Ensures that systems are in place to assure product quality.

• 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.

• Establish and implement laboratory training programs, which assess knowledge, skills, and abilities, as well as job performance and competency.

• Participates in the annual budgeting process and operates the laboratory within budgetary guidelines.

• Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance.

• Negotiates with outside vendors to ensure appropriate volume discounts, unit pricing, product quality and suitability, and service.

• Provides technical direction and expertise to new BioLife projects or product lines requiring laboratory support and evaluation.

• Advise management, quality assurance, regulatory, and technical personnel of laboratory activities.

• Prepares reports and technical papers.

• Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping and Kaizen.

• Provides leadership in problem identification, investigation, and resolution.

• Directly supervises laboratory operations managers, oversees supervision of general laboratory supervisor, area coordinators, and laboratory staff.

• Works in conjunction with BioLife Quality Assurance Senior Management team in the implementation, monitoring, and maintenance of the laboratory quality systems.

• Interviews, hires, and oversees performance of laboratory staff.

• Ensures that proper training is received and documented.

• 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.

• Other duties as assigned or necessary for operation of laboratory.

DIMENSIONS AND ASPECTS

• Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. 

• Demonstrate work history of above average performance and attendance.

• Excellent interpersonal skills and communication skills including written, verbal and oral presentations.

• Result oriented with ability to adapt to changing priorities.

• Attention to detail and organizational skills with analytical and problem solving skills.

• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.

• Walking, standing, observing others performing work assignments. 

• Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning.

• Ability to work in an office / production environment. 

• Ability to manage a departmental budget.

• Ability to adapt to changing priorities.

Leadership

• Integrity

• Fairness

• Honesty

• Perseverance

• Putting the patient at the center

• Building trust with society

• Reinforcing our reputation

• Developing the business

Decision-making and Autonomy

• Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.

Interaction

• 100-200 direct and indirect reports

• Interfaces with employees of various educational backgrounds and levels within the company.  Must be able to communicate effectively with all these various business partners.

Complexity

• 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.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology).

Desired:

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.

BioLife Compensation and Benefits Summary

For Location:

USA - AL - Hoover

U.S. Base Salary Range:

169,400.00 - 266,200.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - AL - Hoover

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes