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Job Description

Job Title: Senior Manufacturing Associate

Location: Lexington, MA (USA)

About the role:

As a Senior Manufacturing Associate, you will perform routine and non routine manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. You will operate production equipment according to standard operating procedures for producing clinical and/or commercial products and support engineering and validation activities. You will report to the Supervisor, Manufacturing.

The hours for this role are 6:00PM - 6:30AM on a 2-2-3 schedule.

How you will contribute:

• Manage cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps.

• Troubleshoot and escalate process related issues

• Create work orders, initiate and document minor deviations

• Enter data in the Laboratory Information Management System (LIMS), and MODA

• Review manufacturing documentation real-time to ensure compliance and manage events impacting the schedule

• Coordinate sample preparation and testing

• Perform work in a safe manner, notifying management of safety issues and risks

• Participate in tiered visual management system and support continuous improvement initiatives

• Manage equipment and support facility related projects and be a subject matter expert for improvement projects

• Perform standardization, scheduled cleaning, assembly and disassembly and process qualifications and validation for equipment

• Provide technical training for area personnel and act as a qualified trainer

• Identify deviations in process, controls, and guidelines required.

• May work with equipment, technical and supply item vendors

What you bring to Takeda:

• High school diploma and 4-6 years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.

• 3 years Cell Culture/Fermentation experience

• Proficient in computer systems and troubleshooting systems

• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

• Full awareness of current Good Manufacturing Practices

• Proficient in Aseptic Technique

• Experience with business systems such as, LIMs, MODA and other business systems

• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.

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.

• Professional training and development opportunities.

• Tuition reimbursement.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. 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 around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• May require weekend or holiday off shift support as needed

• May adjust work schedule to meet production demands.

• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.

• Gown and gain entry to biotechnology/pharmaceutical manufacturing areas.

• Stand for 6 hours in a production suite, climb ladders and work platforms.

• Stooping or bending to check or trouble-shoot equipment operations.

• Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g. snow storm) you may report to work for their normal shift if management deems necessary. To ensure "Essential Personnel" are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event). These details will be provided by management before any potential inclement weather situation.

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.

This posting excludes Colorado applicants.

#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.

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