Downstream Manufacturing Associate
Takeda•Lexington, MA
•Onsite
About The Position
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.
Requirements
- Normally requires a high school diploma and 0-4 years related industry experience or an Associate’s Degree in Life Sciences/Engineering field.
- Proficient in Aseptic Technique
- 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
Nice To Haves
- Biotech Certificate preferred
- May be required to perform as a subject matter expert for equipment and/or systems
Responsibilities
- 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 escalate 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.
Benefits
- 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
- well-being benefits
- up to 80 hours of sick time per calendar year
- up to 120 hours of paid vacation for new hires
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
