Downstream Manufacturing Associate

Takeda; Lexington (VA); On-site; USD 59,237,000 - 93,677,000; Full time

Job summary

Takeda in Lexington, MA is seeking a Downstream Manufacturing Associate to support production across Cell Culture, Purification, and Solution & Equipment Preparation areas. You will perform routine and critical manufacturing activities under general supervision, ensuring safe, compliant execution of processes.

The role requires a high school diploma or an Associate’s degree in Life Sciences/Engineering, with biotech certification preferred.

Qualifications

• High school diploma or 0-4 years related industry experience, or an Associate’s Degree in Life Sciences/Engineering.
• Biotech Certificate preferred.

Responsibilities

• Perform cGMP manufacturing operations in accordance with SOPs, batch records, and form preparations.
• Execute routine and critical production activities safely and accurately.
• Enter and maintain accurate data in LIMS, MODA, and other business systems.
• Review GMP documentation and identify updates or improvements.
• Prepare and test samples as required.
• Initiate work orders and perform equipment assembly/disassembly, cleaning, standardization, and changeovers.
• Support equipment and process qualifications, validation activities, and continuous improvement initiatives.
• Complete required training on time and provide an annual performance self‑assessment.

Skills

Aseptic technique

Batch records

GMP knowledge

Computer skills

LIMS data entry

Education

High school diploma / Associate degree

Biotech certificate

Tools

LIMS

MODA

Job description

Job Description

About the role:

As a Downstream Manufacturing Associate, you’ll play a vital role in producing high-quality clinical and commercial products. Working under general supervision, you’ll perform routine and critical manufacturing activities across Cell Culture, Purification, and Solution & Equipment Preparation areas. You’ll operate production equipment in accordance with established SOPs, ensuring safe, compliant, and efficient execution of manufacturing processes.

How you will contribute:

• Perform cGMP manufacturing operations in accordance with SOPs, batch records, and form preparations.
• Execute routine and critical production activities safely and accurately.
• Troubleshoot basic process issues and elevate deviations appropriately.
• Complete batch records, logbooks, and form preparation requests.
• Enter and maintain accurate data in LIMS, MODA, and other business systems.
• Review GMP documentation and identify required updates or improvements.
• Prepare and test samples as required.
• Initiate work orders and perform equipment assembly, disassembly, cleaning, standardization, and changeovers.
• Support equipment and process qualifications, validation activities, continuous improvement initiatives, and tiered visual management.
• Complete required training on time, maintain a personal development plan, and provide an annual performance self‑assessment.

What you bring to Takeda:

• Normally requires a high school diploma and 0-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field.
• Biotech Certificate preferred

Proficient in Aseptic Technique

• May be required to perform as a subject matter expert for equipment and/or 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 computer skills

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:

• Please be aware that this position is considered “Essential Personnel.” This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary. To ensure “Essential Personnel” are safe during inclement weather situations Takeda 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 prior to any potential inclement weather situation.
• 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.

Stooping or bending to check or trouble‑shoot equipment operations.

Ability to climb ladders and work platforms.

• Ability to stand for 6 hours in a production suite.

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

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.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Lexington - BIO OPS

U.S. Hourly Wage Range:

$20.77 - $32.63

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.