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Director, Head of Technical transfer and Process Validation

応募後で応募 求人ID R0063367 掲載日 04/06/2022 Location:Lexington, Massachusetts

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Job Description

Director, Head of Tech Transfer and Process Validation

Takeda Pharmaceutical

Lexington MA

About the role:

Join Takeda as the Head of Tech Transfer and Process Validation where you will manage all clinical program tech transfer into MASS BIO OPS and all process validation activities (PV stage 2) and will manage commercial program tech transfer out of MASS BIO OPS (dual sourcing) and continued process verification activities (PV stage 3) . You will also provide project leadership to new product intro/tech transfer into MASS BIO OPS. As well as, guide the tech transfer process which provides speed to FIH and first to market. Oversee MA BIO OPS tech transfer business process and achieve its continued improvement . As part of the Tech Transfer and Process Validation team, you will report to the Head of Technical Services and work with a variety of groups within the faciltiy.

How you will contribute:

  • You will guide and coach TT leads and teams to meet program timeline/milestone requirements. Also, to lead TT governance team discussions.
  • You will build connection with PS Biologics/Cell therapy team to facilitate joint TT governance and owns clinical long-range planning for Mass Bio Operations.
  • You will develop an process validation team; Provide strategic leadership to the PV function.
  • You will develop managers, team lead and junior staff members for technical and leadership development.
  • You will establish and implement appropriate PV strategies for stage 2 and 3 process validation to include strategies for mixing study, resin/membrane reuse, and hold time study. Achieve continuous improvement to increase efficiency.

Minimum Requirements/Qualifications:

  • BS Degree in Science or Engineering with 10or more years of relevant experiences and 7or more years in a leadership/managerial position.
  • Expertise in leading multiple tech transfer of biological molecules (Mabs and recombinant proteins to internal MFG facilities and external CDMOs
  • .Knowledge of Biologics upstream/downstream process development, working knowledge of analytical method development and method transfer
  • Experience with staff management, able to develop people and teams
  • Experience leading multiple tech transfers to all facility for early stage and late-stage clinical production and PPQ campaign for market application.
  • Technical experience in cell culture and purification.
  • Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI)
  • Experience defining process validation strategy, process validation master plan, process validation protocol and reports

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
  • Flexible Work Paths
  • Tuition reimbursement

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.



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.


USA - MA - Lexington - BIO OPS

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Full time