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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

The Cell Therapy Laboratory Operations Manager will be responsible for managing and conducting the daily laboratory operations for blood products, primarily leukopaks, ensuring accurate sample processing, quality control testing and data reporting is achieved. This individual will also serve as the subject matter expert for cell therapy processing/manufacturing/analysis (i.e. sterile welding, centrifugation, cryopreservation, cell isolation, viability testing, cell count testing) in the US, performing the processing, conducting future trainings, and at some point, expanding the cell therapy laboratory operations team.

Primary Responsibilities:

+ **Leads All Aspects of Laboratory Operations and Planning**

+ Manage laboratory budgets, including procurement of materials and allocation of resources

+ Coordinate laboratory activities and projects, ensuring timely completion and accuracy

+ Collaborate with other departments to integrate laboratory activities with organizational objectives

+ **Leukopak Processing After Collection:**

+ Pipetting: Accurately transfer small volumes of leukopak samples using pipettes to ensure precise measurements for downstream applications.

+ Sterile Welding: Use sterile welding techniques to connect tubing and containers in a sterile environment, preventing contamination during leukopak processing.

+ Centrifugation: Separate different components of the leukopak by spinning the samples at high speeds in a centrifuge, isolating cells from plasma and other components.

+ Cryopreservation: Preserve leukopak samples by freezing them at very low temperatures, ensuring long-term viability of the cells for future use.

+ **Perform Leukopak Quality Control Analysis:**

+ Appearance: Inspect leukopak samples for any visual abnormalities or contamination.

+ Viability Testing: Assess the health and viability of cells within the leukopak using specific assays to ensure they are suitable for further processing or research.

+ Cell Count Testing: Perform cell counts to determine the concentration of cells in the leukopak, ensuring accurate and consistent results.

+ **CLIA Designee Responsibilities:**

+ Oversee and ensure compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations during quality control analysis (medium complexity tests).

+ Maintain high standards of accuracy and reliability in laboratory testing procedures.

+ **Draft and Perform Regular Updates of SOPs:**

+ Create and regularly update Standard Operating Procedures (SOPs) for leukopak processing and quality control analysis.

+ Ensure SOPs are comprehensive, clear, and reflect current best practices and regulatory requirements.

+ **Support Donor Qualification:**

+ Assist in evaluating potential donors for leukopak collections, including performing cell count analysis to ensure donor suitability.

+ Assist in selecting donors for leukopak collection requests based on specific customer requirements and donor qualifications.

+ **Maintain and Update Leukopak Donor Master File:**

+ Regularly update the master file with results from external laboratories and other relevant data.

+ Ensure the master file is current and comprehensive.

+ **Perform Root Cause Analysis for Deviations or Complaints:**

+ Investigate and identify the root causes of any deviations or complaints related to processed leukopaks.

+ Implement corrective actions to prevent recurrence and improve processing quality.

+ **Team Leadership/Development:**

+ Identify future resource needs and supervise future cell therapy laboratory operations personnel.

+ Responsible for all personnel functions including hiring, assignment and direction of work, development and training of staff, disciplinary action and termination, and maintenance of all personnel records

+ Actively delegates, monitors, and holds responsible the laboratory operations team for their performance.

+ Coaches and leads the laboratory operations team through effective feedback.

+ **Training and Education:**

+ Serve as a subject matter expert and provide training/guidance as needed to other donor centers and their processing staff

Knowledge, Skills, and Abilities:

+ Knowledge and compliance of local, state and federal regulations to include but not limited to GCP/GCLP, 21 CFR Part 1271, CLIA/CAP and HIPPA

+ Intermediate to advanced computer skills in Microsoft Word, Outlook, Excel, Teams

+ Excellent interpersonal and communication skills

+ Must be flexible and able to multi-task in a fast-paced environment, and be a team player

Education and Experience:

+ Bachelor’s degree or equivalent in medical technology or clinical laboratory science from an accredited institution

+ Licensed MLT

+ Eligible to serve as a CLIA laboratory supervisor via education and experience

+ SBB (Specialist in Blood Banking) certification highly preferred

+ Minimum 3 years of clinical laboratory experience (BS), OR minimum 6 years of clinical laboratory experience (AS or AAS)

+ Experience working in blood banking preferred

+ Experience supervising and mentoring others preferred

+ Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

This position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 531902

**Type:** Regular Full-Time

**Job Category:** Manufacturing