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Staff Engineer Cell Culture Process Development

応募後で応募 求人ID R0065651 掲載日 05/10/2022 Location:Lexington, Massachusetts

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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Staff Engineer Cell Culture Process Development where you will contribute to the development and characterization of cell culture processes used in the production of protein therapies. You will participate in process transfer to internal and external manufacturing facilities and support manufacturing activities. You will also be expected to independently execute studies and provide technical leadership to project teams, outside partners and contract organizations.. As part of the Bioprocess Development Organization, you will report to Director, Process Development.

How you will contribute:

  • Execute cell culture development experiments to develop cell culture processes for the production of investigational and commercial products.

  • Oversee execution of laboratory experimentation using bench top bioreactors, small scale expansion systems and high throughput systems. Activities include optimizing process controlling strategies, process characterization and evaluating overall process robustness.

  • Oversee data analysis and communication of results within presentations and formal process development reports. Manage all activities associated with execution of experimentation and will participate in a team to design experiments and discuss results.

  • May support global CMC team activities though acting as technical representative and providing input to CMC team activities and decisions.

  • Interact with both internal and external manufacturing sites and supporting cell culture specific activities, such as technical transfer and process oversight.

Minimum Requirements/Qualifications:

  • Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 8+ years relevant industry experience

  • Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 6+ years relevant industry experience

  • PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience

  • Bachelors or Masters: Extensive experience in CMC pharmaceutical development for active pharmaceutical ingredients and drug products under cGMP's

  • Sound knowledge of current Good Manufacturing Practices (cGMP)

  • Previous experience with the use of contract facilities

  • Experience working in a multi-disciplinary team environment

  • PhD: Demonstrated mastery of subject or area related to field

  • Experience with mammalian-based fed batch culture processes and operation of laboratory scale stirred tank bioreactors

  • Experience in statistical methodologies, such as Design of Experiments (DOE), to promote process modeling for application towards the development, characterization and robustness of a process.

  • Familiarity with large scale manufacturing, technical transfer activities and working within quality systems is preferable.

  • Late stage process development experience, such as process characterization, is preferable.

  • May require approximately 5-10% travel.

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.

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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

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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