Takeda Pharmaceuticals
Cell Therapy QA Manager
Takeda Pharmaceuticals, Boston, Massachusetts, us, 02298
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that
the information I provide in my application will be processed in line with
Takeda’s
Privacy Notice
and
Terms of Use .
I further attest that all information I submit in my employment application
is
true to the best of my knowledge. Job Description
Job Title : Cell Therapy QA Manager Location : Cambridge, MA About the role:
The Cell Therapy QA Manager will report to the Director Cell Therapy Product Quality. You will lead and execute GMP QA operational activities associated with Takeda’s internal GMP cell therapies manufacturing facility. You will ensure compliance to regulations and Takeda procedures for internal cGMP manufacturing and testing of clinical-phase cell therapy programs. Directly manage the development of cGMP quality operational processes which support clinical-phase cell therapies. You will be specifically focused on GMP QA support for manufacturing operations. How you will contribute:
Employ GMP QA expertise and principles during the development, manufacturing, testing and disposition of clinical-phase cell therapies to ensure product quality and achieve our goals. Be a GMP QA subject matter expert responsible for well-documented and compliant resolution of deviations, investigations and CAPAs in field of responsibilities. Interact with quality team members and your team to support site goals, projects, and issue resolution. Manage internal quality improvement programs in responsible area: evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs. Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance in field of responsibilities. Issue, review GMP documentation (e.g., batch records, SOPs, job aids) needed for internal manufacturing operations. Review batch record documentation, ensure compliance and accuracy, and make final disposition decision of cell therapy investigational material for use in Takeda-sponsored clinical studies. Participate in daily onsite quality guidance and collaborate throughout the company, using quality and manufacturing expertise to troubleshoot problems, interpret data, and applying risk-based approach for ongoing manufacturing operations and related quality events. Represent QA in site operations from thaw of starting material to drug product filling and labeling. What you bring to Takeda:
Bachelor’s Degree in Biology, Microbiology, Chemistry or related field. Master’s Degree in Microbiology, Biology, Chemistry or related field preferred 4+ years of experience in cGMP Quality Assurance Working knowledge of cell or gene therapy product testing, manufacturing or development Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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 deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is
an important factor
as you consider the next step in your career. We are committed to
equitable
pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA
U.S. Base Salary Range: 96,600.00 - 151,800.00
The estimated salary range reflects
an anticipated
range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education
attained
, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be
in accordance with
state or local minimum wage requirements for the job location. U.S. based
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
U.S.
based employees
may be
eligible to
participate
in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and
well-being
benefits, among others. U.S.
based employees are also eligible to receive, per calendar year, up to
80 hours
of sick time, and new hires are eligible to
accrue
up to
120 hours of paid vacation. 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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt Yes #J-18808-Ljbffr
the information I provide in my application will be processed in line with
Takeda’s
Privacy Notice
and
Terms of Use .
I further attest that all information I submit in my employment application
is
true to the best of my knowledge. Job Description
Job Title : Cell Therapy QA Manager Location : Cambridge, MA About the role:
The Cell Therapy QA Manager will report to the Director Cell Therapy Product Quality. You will lead and execute GMP QA operational activities associated with Takeda’s internal GMP cell therapies manufacturing facility. You will ensure compliance to regulations and Takeda procedures for internal cGMP manufacturing and testing of clinical-phase cell therapy programs. Directly manage the development of cGMP quality operational processes which support clinical-phase cell therapies. You will be specifically focused on GMP QA support for manufacturing operations. How you will contribute:
Employ GMP QA expertise and principles during the development, manufacturing, testing and disposition of clinical-phase cell therapies to ensure product quality and achieve our goals. Be a GMP QA subject matter expert responsible for well-documented and compliant resolution of deviations, investigations and CAPAs in field of responsibilities. Interact with quality team members and your team to support site goals, projects, and issue resolution. Manage internal quality improvement programs in responsible area: evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs. Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance in field of responsibilities. Issue, review GMP documentation (e.g., batch records, SOPs, job aids) needed for internal manufacturing operations. Review batch record documentation, ensure compliance and accuracy, and make final disposition decision of cell therapy investigational material for use in Takeda-sponsored clinical studies. Participate in daily onsite quality guidance and collaborate throughout the company, using quality and manufacturing expertise to troubleshoot problems, interpret data, and applying risk-based approach for ongoing manufacturing operations and related quality events. Represent QA in site operations from thaw of starting material to drug product filling and labeling. What you bring to Takeda:
Bachelor’s Degree in Biology, Microbiology, Chemistry or related field. Master’s Degree in Microbiology, Biology, Chemistry or related field preferred 4+ years of experience in cGMP Quality Assurance Working knowledge of cell or gene therapy product testing, manufacturing or development Important Considerations
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
Work in a cold, wet environment.
Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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 deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is
an important factor
as you consider the next step in your career. We are committed to
equitable
pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA
U.S. Base Salary Range: 96,600.00 - 151,800.00
The estimated salary range reflects
an anticipated
range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education
attained
, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be
in accordance with
state or local minimum wage requirements for the job location. U.S. based
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
U.S.
based employees
may be
eligible to
participate
in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and
well-being
benefits, among others. U.S.
based employees are also eligible to receive, per calendar year, up to
80 hours
of sick time, and new hires are eligible to
accrue
up to
120 hours of paid vacation. 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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt Yes #J-18808-Ljbffr