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BBG Advanced Therapies is a full-service biomanufacturing organization that delivers comprehensive, cell and cell-based manufacturing solutions for advanced therapies. Leveraging its showcase facility designed to be compliant with FDA, EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on translating and refining early-stage processes to scale for commercial readiness.

Pay Rate: Hourly $26.90- $32.00/ Annually $55,952.00-$66,650.00

Job Title: Blood & Tissue Manufacturing Technologist, BBG AT Processing Lab

Revision: 0001

Job Code: 704218

Shift: Tuesday-Saturday 8:30am-5:30pm

FLSA: OT Eligible

Hybrid? N

Dept.: BBG Advanced Therapies Processing

Business Unit: BBG Advanced Therapies

CPF Level: P2

General Summary

Responsible to perform component modification, Component sampling, cord blood testing and quality control testing, all tissue processing, and all quarantine (blood, plasma and tissue) procedures.

Maintain knowledge of all current Standard Operating Procedures (SOPs) required to perform effectively.

Ensure all products are processed in accordance with (SOPs) and governing regulatory agencies.

Maintain accurate records and documentation as well as recognize unusual test results and resolve discrepancies.

Maintains all technical activities to include training and performance of high complexity routine laboratory procedures.

Maintain excellent communication with the department and throughout the organization.

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).

Support, communicate and reinforce the mission and vision of the enterprise.

Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Major Duties and Responsibilities

Essential Tasks

Competently perform all assigned departmental duties to include performing Pre‐Analytical tasks [receipt, qualification, and modification of components, tissue and samples] and testing on blood and tissue products.

Perform laboratory testing through performance of high complexity, routine, and special laboratory procedures.

Perform complex mathematical calculations, evaluate test results in an accurate and timely manner, and recognize and report unusual test results.

Responsible for the review and approval of all test results.

Analyze quality control data and resolve discrepancies that may occur in reporting these tests.

Perform STBTC laboratory quarantine procedures (blood, plasma and tissue).

Accurately maintain all record and documentation of quarantine products (blood , plasma and tissue).

Operate required equipment utilizing established protocols and within quality control limits.

Perform calibrations, quality control, and maintenance on equipment used in the performance of duties.

Recognize equipment malfunctions and/or technical problems and take appropriate steps to resolve.

Use independent judgment and/or knowledge to resolve complex problems.

Perform product labeling and investigate any issues which prevents labeling.

Perform computer entry of component modifications accurately.

Perform processing, analytical testing, packaging and labeling of cord blood product, associated cord blood sample(s), PBSC product(s) and PBSC associated sample(s), according to procedures of NMDP, AABB, FACT, FDA, ISO, FDA, organizational and cGMP‐cGTP

Utilize the data management system to include Excel, Word, and MAC.

Assist with training of new employees as needed and maintain annual training competencies for the testing laboratory.

Recognize unusual results and difficulties encountered in all phases of laboratory performance to include purchased goods, environmental, mechanical and product related.

Assist and develop testing procedures in accordance with NMDP, AABB, AATB, FACT, ISO, FDA, organizational and cGMP‐cGTP standards.

Assist with validation of all procedures performed thus providing for the safety and efficacy of products to include preventative maintenance.

Attend meetings, seminars, and other workshops as required.

Be knowledgeable and follow established South Texas Blood & Tissue Center laboratory guidelines, policies and procedures for biological and chemical safety.

Abide by all safety regulations.

Maintain a close working relationship with all Manufacturing Laboratory management and staff.

Assist with mentoring of new employees and/or volunteers.

Performs other duties as assigned.

Non‐Essential Tasks

Run departmental errands if needed.

May have interaction and/or exposure with various groups, VIPs, and/or media.

Assist in other Component Laboratory areas as directed.

Education

Requires a Bachelor’s Degree from an accredited college or university with major course work relative to the field of assignment.

The required major is Medical Technology (MT), Clinical Laboratory Science (CLS), or equivalent.

Experience

Requires two or more years of clinical laboratory experience, to include but not limited to: testing, equipment maintenance/validation and quality control.

Knowledge

Must acquire a working knowledge of quality and laboratory systems.

Must recognize and facilitate resolution of unusual results or difficulties encountered in all phases of laboratory work.

Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies.

Must have a working knowledge of equipment and procedures for various laboratory techniques.

Skills

Must be prepared to identify root causes of problems and select the best course of action when circumstances require.

Must have strong computer skills.

Must be capable of evaluating, interpreting and reporting accurate/valid test results by current testing methodologies.

Must have excellent written and oral communication skills.

Must maintain competency in skills required for Apheresis Platelet manufacturing, Component QC, Product Quarantine, and labeling.

Must have strong manual dexterity and technical abilities in the use of Texas Cord Blood Bank (TCBB) processing and testing equipment.

Must be competent in processing and testing equipment required in a clinical laboratory.

Abilities

Must be a self‐starter and self‐directed worker.

Must be able to keep information confidential.

Must be able to make good sound judgment decisions.

Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports.

Must be neat in appearance and well groomed.

Must be professional, detail oriented, self‐motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently.

Must perform well in repetitive work situations.

We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!

All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:

• Competitive salary

• 100% Employer Paid Life Insurance

• 401(k) with Employer Contribution

• 100% Employer Paid Long-term Disability Plan

• Paid Time Off (PTO)

• 100% Employer Paid AD&D

• Extended Illness Benefits (EIB)

• 100% Employer Paid Employee Assistance Program

• Incentive Compensation Plan

• Group Health Medical Plan with prescription coverage

• Shift Differentials

• Variety of Voluntary Supplemental Insurances

• Paid Holidays

• Voluntary Dental Coverage

• Educational Assistance Program

• Voluntary Vision

BBG Advanced Therapies, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please clickhere (http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf) . BBG Advanced Therapies maintains a Tobacco & Drug-Free Workplace.