Senior Research Specialist II応募後で応募 求人ID R0097210 掲載日 05/30/2023 Location:Social Circle, Georgia
About the role:
The Senior Research Specialist II, reports to the the Associate Director – Manufacturing Science Albumin. You will provide process support to the Manufacturing Process by investigating and troubleshooting technical issues within the Social Circle purification manufacturing departments. You will assist your quality and manufacturing partners in maintaining process compliance, aiding in the implementation of yield and process improvements, and supporting process validation activities.
How you will contribute:
Contribute to technical feasibility analysis of complex research and design concepts and make sound technical recommendations.
Solve routine and complex design and scientific tasks. Select sound techniques to make design recommendations.
Support commercial manufacturing operations to meet fulfillment targets (lot release timing).Complete CAPA tasks to ensure on time release of lots; product impact assessments, corrective and preventive actions and root cause investigations.
Evaluate and prepare complex product impact assessments for process exceptions.
Conduct studies and improvement projects for product quality, process robustness, product yield and cycle time based on recent technical knowledge.
Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time.
May provide training and guidance to junior members within the discipline. Provide advice and assistance to team members regarding unique problems.
Design new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
Maintain current knowledge of relevant QSRs and other regulatory requirements to ensure compliance in all research, data collection and reporting activities.
In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines. Establish leadership in science and technology through presentations at national and international conferences as well as publication of research articles in peer reviewed journals
Adhere to quality system, understand and apply applicable corporate, divisional and departmental procedures. Knowledge of related regulations and guidance (e.g., USP, ICH, and regional compendia) to facilitate compliance.
Present information to auditors
May work on small scale experiments
Author and execute process validation protocols and final reports (e.g. process performance qualification, mixing study, hold study, etc). Coordinates and supports training and execution of validation activities. Evaluate results relative to protocol requirements, definitions and/or study goals. Provide analytical interpretation of result from studies to stakeholders.
Requires a bachelors' degree preferably in science, engineering, or related scientific field with 8+ years of related experience. Advance degree preferred.
Knowledge of FDA-regulated manufacturing environments.
Knowledge of GMPS FDA guidelines
Experience with process validation and regulatory submission
Discuss normally encountered technical and project management issues, both verbally and in written form.
Knowledge of GMPs, FDA guidelines and process validation.
Manage multiple cross-functional teams simultaneously.
Experience with Minitab or other statistical software.
Lead teams and work as a collaborative team member.
Experience with DOE (Design of Experiments), six sigma, and lean manufacturing
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 paid time off for vacation, sick leave, and volunteering
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional development and training opportunities
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. In this role, 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, as necessary.
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 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.
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.