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Senior Development Associate – Technical Operations Downstream

応募後で応募 求人ID R0067188 掲載日 05/16/2022 Location:Brooklyn Park, Minnesota

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Job Description

About the role:

Join Takeda as a Senior Development Associate- Technical Operations Downstream where you will lead tech transfers of products into the facility at bench and pilot scale and subsequently to commercial scale. You will manufacture technical support including batch records, deviations, change controls, investigations, life cycle management, scale down modeling, satellite cultures, process validation, data tracking and trending, and supporting CMC regulatory filings. This is a senior role that has the ability to influence decisions within the technical operations group and broader site. As part of the Technical Operations team, you will report to Senior Manager Technical Operations and work with other members of the Technical Operations group.

How you will contribute:

  • You will act as primary owner responsible for maintaining, operating, troubleshooting equipment and instrumentation used in technical operation lab.

  • You will train others on how to operate laboratory equipment.

  • You will prepare protocols, technical reports, presentations, and project summaries.

  • You will present and discuss data and experimental conclusions at group departmental meetings and internal seminars, demonstrating and understanding of the scientific rationale of the experimental designs.

  • You will effectively work with others outside of technical operations.

  • You will make detailed observations, perform important analysis of data, interpret results, and suggest next steps.

  • You will participate in technology transfer, scale up, and product lifecycle management activities.

  • Provide Manufacturing/QC support including record review, on-floor support, investigations, and satellite runs.

  • You will ensure that procedures, lab equipment, data, documentation, activities etc. within the lab are well-controlled and suitable for their intended use.

  • Perform tracking, trending, and statistical analysis of Manufacturing/QC data.

  • Perform literature searches to identify relevant information that can be incorporated in experimental design.

Minimum Requirements/Qualifications:

  • Bachelor's degree in a scientific discipline with 8+ years of experience in the development and manufacturing of biotherapeutics; or Master's degree in a scientific discipline with 6 or more years of experience in the development and manufacturing of biotherapeutics.

  • You will have knowledge of biopharmaceutical processes and methods.

  • Experience with regulatory requirements related to manufacturing and process development.

  • You will have prior experience in GMP manufacturing support.

  • Experience with data tracking and trending, principal component analysis, and DOE (statistical software experience).

  • You will have prior experience with SIP/CIP operations.

  • Self-motivated, developmentally oriented person with a continuous improvement mindset.

  • You will have the ability to explain scientific concepts/train others.

  • You will act as Project Leader in conducting own experiments.

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. #GMSGQ #ZR1 #LI-MA1

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

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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