Cell Therapy Mfg Associate I - ACP
Bloodworks Northwest
Office
Seattle, WA, 98104, US
Full Time
Formerly Puget Sound Blood Center and Lane Blood Center, Bloodworks is backed by more than 70 years of Northwest history and 250,000 donors. A national leader in transfusion medicine, Bloodworks has been chosen to serve more than 90 hospitals in Washington, Oregon and Alaska – partnering closely with local hospitals to deliver the highest level of patient care. Patients with traumatic injuries, undergoing surgeries or organ transplantation, or receiving treatment for cancer and blood disorders all depend on our services, expertise, laboratories and research. We are local, nonprofit, independent, volunteer-supported and community-based.
We have a wonderful new job opportunity for a Cell Therapy Manufacturing Associate (CTMA) to join our Advanced Therapies team. As a member of the Advanced Therapies Laboratory, CTMAs perform the technical aspects of receiving, labeling, processing, testing, storing, and distributing cellular products and samples. Additionally, CTMAs perform batch record review, database entry, and activities related to the non-conformance process.
Principal responsibilities include, but are not limited to:
• Operate and maintain laboratory equipment and instruments.
• Process products and coordinate completion of testing (within and outside of Bloodworks), including:
◦ Fractionation, cryopreservation, acquisition and distribution of appropriate samples for testing (microbiology, serology, cell counts, & QC).
◦ Accurately labeling all materials.
◦ Perform QC assays as necessary (enumeration via flow cytometry, colony forming assays, microbiology); and
◦ Ensure adequate stock supplies and equipment required for processing and testing.
• Complete training and competency documentation for advanced cell processing on special equipment and pertinent regulations controlling these products.
• Perform batch record review for completeness and accuracy.
• Perform data entry in paper or electronic database.
• Perform logbook review for completeness and accuracy.
• Perform equipment quality control and assist with validation.
• Initiate departmental deviations and investigations.
• Assist in the revision of departmental SOPs and forms.
• Assist in the execution and completion of approved validation protocols.
GENERAL RESPONSIBILITIES:
• Consistently model Bloodworks’ values; contribute and build upon current practices and procedures in support of values, mission, and goals.
• Ensure department’s actions complies with laws, regulations, and organizational policies and practices.
• Function effectively within the team; participate and contribute constructively to produce results in a collaborative manner; exhibit respect for others as well as willingness to help others.
• Challenge and offer support to peers to ensure all are contributing to the success of the organization.
• Provide timely and honest feedback to team members regarding the functionality of the team.
• Recognize potentially hazardous materials, equipment, and situations and follow safety procedures to minimize risk to self and nearby individuals.
• Responsibly support the department budget.
• Proactively recommend systems, resources, and procedures to achieve department’s success.
• Participate in Bloodworks mandated emergency drills.
• Maintain confidentiality of donor and patient medical, financial, and personal information in accordance with HIPAA and other applicable standards/guidelines.
• Complies with all applicable Standard Operating Procedures (SOP) as written.
• Perform other duties as assigned.
OTHER:
Upon demonstrating proficiency in performing the primary responsibilities, the employee may be eligible for promotion to Cell Therapy Mfg. Associate II. Other considerations may include number of high-risk level deviations, number of pending action items, or specialized certification or training in activities that support additional laboratory services and programs in activities, such as Quality, Lean Six Sigma, and Performance Excellence.
REQUIREMENTS:
EDUCATIONS & EXPERIENCE:
• Must qualify as Testing Personnel, Moderate Complexity Testing, under CLIA personnel requirements found in Subpart M of the Code of Federal Regulations.
• Bachelor of Science in medical technology, laboratory science, chemical, or biological science (or equivalent combination of education and experience).
Specific job skills include, but are not limited to:
• Maintain competency and proficiency in Advanced Therapies Processes and Procedures beyond initial 6 months of hire as Cell Therapy Mfg Associate I.
• Functional proficiency with MS Office applications (Word, Excel, PowerPoint, Outlook, Access).
• Knowledgeable about the safe handling of any potentially infectious material such as blood or other biological specimen blood and tissues.
• Knowledgeable about applicable techniques for laboratory processing, aseptic technique, cryopreservation, storage, and distribution
• Knowledgeable about applicable laboratory assays and testing instruments
• Knowledgeable about applicable regulations, such as cGMP, cGTP, CLIA.
• Knowledgeable about applicable cellular therapy standards and industry organizations, such as AABB, FACT, NMDP.
• Ability to work independently with high degree of accuracy and attention to detail.
• Required mental activities include the ability to read, write, comprehend, and speak English (all used frequently). Other required mental activities involve interpersonal skills, teamwork, decision-making, prioritization, teaching, supervising, multi-tasking, problem solving/analysis, independent judgment/action, performance of basic math, and basic programming.
• Required physical activities include frequent standing, sitting, walking, talking, hearing, reaching, handling, feeling and repetitive motions of hands/wrists. Other required physical activities used less frequently include bending (used occasionally); stooping, kneeling, and climbing, (all used rarely).
• Ability to occasionally push and pull an average of 200 pounds is required.
• Ability to frequently lift and carry an average of 50 pounds throughout the workday is required.
WORKING CONDITIONS:
• This is a highly regulated position and is subject to meeting various regulatory requirements and accrediting agencies standards.
• Job conditions to be expected include regular weekend work and occasional evenings and holidays. Participate in on-call duties per departmental policies.
• As this is an essential position with direct responsibility to donors and/or patients, incumbent should be prepared to work extended shifts, even during periods of inclement weather or other emergencies.
• This position has direct exposure to blood borne pathogens.
Benefits and Perks:
Employees regularly scheduled for 24+ hours per week are covered by medical, dental, vision, and life insurance, with family coverage also available. Also, able to participate in retirement plans (401a & 401b), consolidated paid leave program (4.8 – 6.8 weeks of time off accrued per year, based on length of service), subsidized backup childcare program, subsidized transit program, educational reimbursement.
Bloodworks Northwest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.
We have a wonderful new job opportunity for a Cell Therapy Manufacturing Associate (CTMA) to join our Advanced Therapies team. As a member of the Advanced Therapies Laboratory, CTMAs perform the technical aspects of receiving, labeling, processing, testing, storing, and distributing cellular products and samples. Additionally, CTMAs perform batch record review, database entry, and activities related to the non-conformance process.
Principal responsibilities include, but are not limited to:
• Operate and maintain laboratory equipment and instruments.
• Process products and coordinate completion of testing (within and outside of Bloodworks), including:
◦ Fractionation, cryopreservation, acquisition and distribution of appropriate samples for testing (microbiology, serology, cell counts, & QC).
◦ Accurately labeling all materials.
◦ Perform QC assays as necessary (enumeration via flow cytometry, colony forming assays, microbiology); and
◦ Ensure adequate stock supplies and equipment required for processing and testing.
• Complete training and competency documentation for advanced cell processing on special equipment and pertinent regulations controlling these products.
• Perform batch record review for completeness and accuracy.
• Perform data entry in paper or electronic database.
• Perform logbook review for completeness and accuracy.
• Perform equipment quality control and assist with validation.
• Initiate departmental deviations and investigations.
• Assist in the revision of departmental SOPs and forms.
• Assist in the execution and completion of approved validation protocols.
GENERAL RESPONSIBILITIES:
• Consistently model Bloodworks’ values; contribute and build upon current practices and procedures in support of values, mission, and goals.
• Ensure department’s actions complies with laws, regulations, and organizational policies and practices.
• Function effectively within the team; participate and contribute constructively to produce results in a collaborative manner; exhibit respect for others as well as willingness to help others.
• Challenge and offer support to peers to ensure all are contributing to the success of the organization.
• Provide timely and honest feedback to team members regarding the functionality of the team.
• Recognize potentially hazardous materials, equipment, and situations and follow safety procedures to minimize risk to self and nearby individuals.
• Responsibly support the department budget.
• Proactively recommend systems, resources, and procedures to achieve department’s success.
• Participate in Bloodworks mandated emergency drills.
• Maintain confidentiality of donor and patient medical, financial, and personal information in accordance with HIPAA and other applicable standards/guidelines.
• Complies with all applicable Standard Operating Procedures (SOP) as written.
• Perform other duties as assigned.
OTHER:
Upon demonstrating proficiency in performing the primary responsibilities, the employee may be eligible for promotion to Cell Therapy Mfg. Associate II. Other considerations may include number of high-risk level deviations, number of pending action items, or specialized certification or training in activities that support additional laboratory services and programs in activities, such as Quality, Lean Six Sigma, and Performance Excellence.
REQUIREMENTS:
EDUCATIONS & EXPERIENCE:
• Must qualify as Testing Personnel, Moderate Complexity Testing, under CLIA personnel requirements found in Subpart M of the Code of Federal Regulations.
• Bachelor of Science in medical technology, laboratory science, chemical, or biological science (or equivalent combination of education and experience).
Specific job skills include, but are not limited to:
• Maintain competency and proficiency in Advanced Therapies Processes and Procedures beyond initial 6 months of hire as Cell Therapy Mfg Associate I.
• Functional proficiency with MS Office applications (Word, Excel, PowerPoint, Outlook, Access).
• Knowledgeable about the safe handling of any potentially infectious material such as blood or other biological specimen blood and tissues.
• Knowledgeable about applicable techniques for laboratory processing, aseptic technique, cryopreservation, storage, and distribution
• Knowledgeable about applicable laboratory assays and testing instruments
• Knowledgeable about applicable regulations, such as cGMP, cGTP, CLIA.
• Knowledgeable about applicable cellular therapy standards and industry organizations, such as AABB, FACT, NMDP.
• Ability to work independently with high degree of accuracy and attention to detail.
• Required mental activities include the ability to read, write, comprehend, and speak English (all used frequently). Other required mental activities involve interpersonal skills, teamwork, decision-making, prioritization, teaching, supervising, multi-tasking, problem solving/analysis, independent judgment/action, performance of basic math, and basic programming.
• Required physical activities include frequent standing, sitting, walking, talking, hearing, reaching, handling, feeling and repetitive motions of hands/wrists. Other required physical activities used less frequently include bending (used occasionally); stooping, kneeling, and climbing, (all used rarely).
• Ability to occasionally push and pull an average of 200 pounds is required.
• Ability to frequently lift and carry an average of 50 pounds throughout the workday is required.
WORKING CONDITIONS:
• This is a highly regulated position and is subject to meeting various regulatory requirements and accrediting agencies standards.
• Job conditions to be expected include regular weekend work and occasional evenings and holidays. Participate in on-call duties per departmental policies.
• As this is an essential position with direct responsibility to donors and/or patients, incumbent should be prepared to work extended shifts, even during periods of inclement weather or other emergencies.
• This position has direct exposure to blood borne pathogens.
Benefits and Perks:
Employees regularly scheduled for 24+ hours per week are covered by medical, dental, vision, and life insurance, with family coverage also available. Also, able to participate in retirement plans (401a & 401b), consolidated paid leave program (4.8 – 6.8 weeks of time off accrued per year, based on length of service), subsidized backup childcare program, subsidized transit program, educational reimbursement.
Bloodworks Northwest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age, protected veteran status, disability status, or any other characteristic protected by law.
Cell Therapy Mfg Associate I - ACP
Office
Seattle, WA, 98104, US
Full Time
August 15, 2025