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Job Description

Job Title: Associate Director, Cell Therapy Quality Control

Location : Cambridge, MA

About the role:

• The Associate Director, Cell Therapy Quality Control (CT QC), is responsible for overall cGMP compliance, operation, and continuous improvement of an internal Cell Therapy QC Analytical Laboratory, and the personnel involved in QC technology transfer, method validation and QC testing of cell therapy medicinal products used in Takeda clinical studies.

• You will be directly responsible for a team of QC subject matter experts and manages Quality Control Analytical operations which support development, manufacturing and testing of new cell therapies.

• The Associate Director, CT QC develops strategic direction and ensures execution of continuous improvement through idea development, plan creation, implementation, and championing project management methodology for projects of high complexity and risk.

How you will contribute:

• Responsible for operational management of the QC analytical laboratory in the R&D Cell Therapy Manufacturing Facility according to cGMP and Takeda quality standards.

• Provide strategic direction and expertise for analytical method technology transfer, phase appropriate method validation, analytical equipment qualification, reagents qualification, stability testing, and in-process and final product testing.

• Develop a QC team by establishing QC industry best practices, training, testing performance expectations, data integrity and review programs.

• Provide strategic direction and expertise to lead analytical method troubleshooting and lead investigations into Out-of-Specification and Out-of-Trend results and other testing discrepancies.

• Represent QC analytical aspects of cell therapy programs and decisions during audits, health authority inspections and to site/function senior leadership.

• Collaborate with other individuals and teams across the site in fulfillment of both department and site goals, including colleagues and counterparts across other areas within QC, QA, Manufacturing, Operations, Supply Chain Management, Facility and IT. Work with members from Regulatory Affairs, Human Resources, and other important support functions.

• As this is a leadership position with direct reports, a core function of the role pertains to the recruitment, onboarding, development, management, motivate and retention of employees.

• You will be responsible to support department budget compliance and coordinating any budgetary corrections or adjustments.

• Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance.

• Develop solutions to complex Quality issues which potentially impact cell therapy manufacturing and testing to ensure patient safety, and compliance with cGMP regulations and Takeda quality expectations.

• Provide leadership to ensure well-documented, and compliant resolution of quality investigations and implementation of corrective actions that maintain a continual state of cGMP compliance.

• Additional responsibilities as assigned.

Technical/Functional (Line) Expertise

• A comprehensive understanding of cell therapy development, manufacturing, and testing.

• Experience with cGMP regulations, Quality Control expectations and requirements, and industry best practices.

• Strong scientific and working knowledge of immunological and cell culture-based methodology such as flow cytometry, PCR (polymerase chain reaction), ELISA ( enzyme-linked immunosorbent assay) and sequencing.

• Experience in technology transfer and method validation.

• Experience with laboratory/facility design and subsequent construction/commissioning is a plus.

Leadership

• Strong interpersonal skills including ability to enable trust, build relationships, constructively challenge conventional thinking, influence stakeholders, lead and partner in a team setting, share information and deliverables.

• Effective communication skills including verbal, written and proven ability to influence, lead, and motivate others

• Exemplify the Takeda Values: Integrity, Fairness, Honesty & Perseverance

• Organizationally able to and lead change, deliver strong results and build the confidence as well as trust of stakeholders

Decision-making and Autonomy

• Ability to make informed, data-driven, difficult, robust, rationalized and timely decisions.

Interaction

• Experience interacting and collaborating with cross-functional global team

• Experience partnering and engaging with contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs).

Innovation

• Have flexible and creative problem-solving skills.

• Anticipate potential problems and risks related to quality expectations and regulatory compliance, create action plans, and implement solutions.

Complexity

• Responsible for effectively managing QC testing schedules and strategies

• Provide recommendations to the Director of Quality to make informed decisions regarding laboratory issues and overall QC test performance, monitoring and trending

• Provide leadership initiative and situational ownership in the event of unplanned test issues (e.g., out-of-specification and anomalous results)

• Monitor and meet established goals and projects.

What you bring to Takeda:

Minimum requirements:

• Bachelor's Degree in Biology, Chemistry or related field

• 7 years of experience in cGMP Quality Control

• Prior supervisory or management experience

• Preferred requirements:

• Doctor's Degree in Biology, Chemistry or related field

• Working knowledge of cell or gene therapy product testing, manufacturing or development

• You will support biopharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities and analytical laboratories (this list is not exhaustive).

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• 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.

This posting excludes Colorado applicants.

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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