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Job Description

About the role:

Join us as a Manufacturing Sciences Senior Research Specialist II at Takeda. You will focus on supporting the manufacturing processes and solving technical issues within the Social Circle purification manufacturing departments. Your responsibilities include assisting quality and manufacturing partners in ensuring process compliance, implementing improvements in yield and process, and supporting process validation activities. You will report to the Associate Director of Manufacturing Science Albumin at our Covington, GA manufacturing site.

To excel in this position, it is crucial to have hands-on experience supporting manufacturing processes in large- or small-scale experiments and a knowledge of protein purification techniques such as column chromatography and filtration systems.

How you will contribute: 

·       Act as an expert in protein purification, with a preference for experience in plasma proteins, providing technical support for complex manufacturing scale investigations and process improvement projects.

·       Create new approaches to complex problems by adapting and modifying standard technical principles. Integrate new methods and technologies to enhance our products/processes.

·       Act as a subject matter expert with technical and practical knowledge in column chromatography, filtration systems, and protein purification techniques.

·       Evaluate and prepare detailed product impact assessments for process exceptions.

·       Support commercial manufacturing operations to meet fulfillment targets, ensuring lot releases. Complete Corrective and Preventive Actions (CAPA) tasks to ensure lot releases, including product impact assessments and root cause investigations.

·       Work independently to initiate and conduct studies and improvement projects focused on product quality, process robustness, product yield, and cycle time using up-to-date technical knowledge. Also, provide training and guidance to junior team members within the discipline, offering regular guidance on unique issues.

·       Have in-depth knowledge of GxP and related regulations and provide expert insights to facilitate efficient product registration. Participate in reviewing such regulations.

·       Follow the quality system and apply applicable corporate, divisional, and departmental procedures, ensuring compliance with related regulations and guidance (e.g., USP, ICH, and regional compendia).

·       Present information to auditors and collaborate with manufacturing and global subject matter experts to identify process improvement opportunities. Also collaborate with appropriate teams to implement improvement projects, including providing validation support and writing submissions. May be involved in small-scale experiments.

·       Collaborate with Manufacturing to promote important metrics such as yields and capacity.

·       Author and implement process validation protocols and final reports (e.g., process performance qualification, mixing study, hold study). Coordinate and support training and execution of validation activities. Evaluate results relative to protocol requirements, definitions, and study goals, providing analytical interpretation to partners.

·       Promote the use of DMAIC tools in problem resolution and projects.

·       Analyze scientific and statistical data using statistical analysis to draw appropriate conclusions.

Minimum Requirements/Qualifications:

·       Requires a bachelor's degree in science, engineering, or a related scientific field, with 6+ years of related experience.

·       Advanced degree preferred. (MS, Ph.D)

·       Knowledge of FDA-regulated manufacturing environments.

·       Has practical and theoretical knowledge in plasma protein purification and biochemistry.

·       Solve routine technical problems.

·       Communicates technical and project management issues verbally and in writing.

·       Familiar with GMPs, FDA guidelines and process validation.

·       Experience with Design of Experiments (DOE), Six Sigma, and lean manufacturing.

·       Available to work shifts, including nights, weekends, and holidays, to support project execution on an infrequent basis (< 5%).

·       Ability to work in a clean room environment for extended periods.

·       Ability to wear personal protective equipment (such as hard hats, safety shoes, safety glasses, and ear plugs) due to safety requirements in specific areas.

Travel on an infrequent basis (< 5 %)

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
• Paid time off for vacation, sick leave, and volunteering
• Community Outreach Programs and company match of charitable contributions·      
• Family Planning Support
• Professional development opportunities
• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.
• 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 to 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.

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