By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job Title: Manufacturing Associate

Location: Alewife/Lexington (USA)

About the role:

With general guidance you will perform routine and important manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs for producing clinical and commercial products.

How you will contribute:

80% - You will perform cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps. Primary responsibilities include the Following:

• Troubleshoot and resolve basic process related issues
• recognize and escalate deviation
• Implement important and routine activities to support production
• Perform Batch Record, Logbook and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS) , MODA.
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed to documentation
• Participate in tiered visual management system and support CI programs
• Complete required training.

10% - You will manage equipment and support facility related projects by:

• Initiate work orders
• Assembly and disassembly of process equipment
• Perform scheduled cleaning of equipment
• Perform standardization of equipment
• Support change over activities
• Execution of equipment and process qualifications and validation

10% - Staff Technical Training

• Maintain training requirements
• Develop personal development plan
• Provide annual performance self-assessment on development plan

What you bring to Takeda:

Essential:

• Normally requires a high school diploma and 2 or more years related industry experience or an associate degree in Life Sciences/Engineering field with 1 year of GMP Manufacturing experience.

Desired:

• Biotech Certificate preferred

Experience with general aspects of the job with a broad understanding of the detailed aspects of the job.

• May perform as a subject matter expert for equipment and Systems
• You are proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures
• Have excellent communication and troubleshooting skills
• Full Awareness of current Good Manufacturing Practices
• Proficient computer skills
• Will work holidays and overtime as required
• May adjust work schedule to meet production demands
• Proficient in Aseptic Technique
• Work cohesively in a team environment
• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
• Own and gain entry to biotechnology/pharmaceutical manufacturing areas
• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force
• Ability to stand for 6 hours in a production suite
• Ability to climb ladders and work platforms
• Stoop or bend to check or trouble-shoot equipment operations
• Ability to work around chemicals (alcohols, acids & bases).

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 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. 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 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 the best 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.

#GMSGQ

#ZR1

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

Worker Type

Worker Sub-Type

Time Type