17 days old

Associate Director, Product Development, Cell Therapy

Millennium Pharma, Inc.
Boston, MA 02109
  • Job Code
    R0014507

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takedas Privacy Notice, Privacy Policy and Terms of Use.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Associate Director, Product Development, Cell Therapy in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

Join Takeda Cell Therapy enthusiastic and collaborative team and contribute to the overall success of our novel cell therapy product development and commercialization. The Associate Director of Product Development in the Cell Therapy team will be responsible for cryopreservation and stability of cell therapy product and manufacturing process development and optimization to support cell therapy product development from preclinical to BLA submission. The candidate should have proven ability to successfully provide technical excellence and leadership to work across functional teams to drive our cell therapy product from development to commercialization and lead lifecycle management.

POSITION ACCOUNTABILTIES:

  • Provide technical expertise to develop formulation and manufacturing process to support clinical trials from Phase I to BLA filing
  • Provide leadership and technical expertise for CMO selection, audit, onsite manufacturing oversight and addressing regulatory queries, etc.
  • Support product technical transfer team, in partnership with the tech transfer Project Manager and across function project team members (Quality, Analytical, cGMP Production, Regulatory, etc.) to ensure timely clinical supply manufacturing including production batch record review, onsite oversight, change controls, and deviation investigation, etc.
  • Provide technical expertise to define and execute process validation strategy to ensure commercial manufacturing readiness and smooth knowledge transfer to commercial teams
  • Support complex and multi-functional Lifecycle management activities such as 2nd generation product formulation and manufacturing process optimization, and provide technical expertise to address product quality related deviations
  • Collaborate with Automation and cGMP experts to identify and build in-house capacity to enable cell process and fill/finish optimization with new manufacturing technologies
  • Collaborate with regulatory and cross-functional teams to define and support regulatory submission filing strategy for INDs, briefing books and BLAs, etc., and serve as technical SMEs to support interactions with health authorities including authoring and reviewing regulatory documents, participating regulatory meetings and providing support for onsite regulatory inspections

EDUCATION, EXPERIENCE AND SKILLS:

  • PhD in Pharmaceutical Chemistry, Chemical Engineering, Bioengineering, or related fields with 8+ years or MSc/BSc with 10+ years of relevant biopharmaceutical industry experience
  • Strong experience as a product and technical lead in developing late stage biopharmaceutical products and commercialization
  • Strong technical understanding and experience in biopharmaceutical product lifecycle management
  • Proven record of technical leadership and cross-functional influence
  • Experience in risk identification and management
  • Working knowledge in cell therapy formulation/process development and manufacturing of cell therapy is preferred
  • Experience in a fast-paced biotech/pharma company and handle multiple projects simultaneously
  • Strong knowledge about cGMP and ICH guidance
  • Strong scientific and technical mastery including strong technical writing and presentation skills
  • Extensive experience in authoring and reviewing relevant regulatory documents, including INDs and BLAs and solid understanding of current regulatory guidelines

KNOWLEDGE AND SKILLS:

  • Proven ability to distill complex plans across multiple programs into an intuitive, simple and clear communication to facilitate prioritization and resourcing
  • Strong interpersonal and leadership skills with the ability to motivate the teams, and resolve conflict situations
  • Highly collaborative team player fostering open communication and facilitates mutual understanding and cooperation among all stakeholders
  • Able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
  • Excellent communication skills and ability to influence stakeholders and leaders across multiple functions.

TRAVEL REQUIREMENTS:

  • Up to 30%, as needed. Some international travel may be required.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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

    Empowering Our People to Shine

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

#LI-KS1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2019-11-25 Expires: 2019-12-24
Sponsored by:
Farm Credit Services of America Logo
Sponsored by:
Bank of America Logo

Featured Jobs[ View All ]

Featured Employers

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Associate Director, Product Development, Cell Therapy

Millennium Pharma, Inc.
Boston, MA 02109

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast