Downstream Manufacturing Associate
$43,202–$67,870 year
On-siteLexington, Massachusetts, United States
Job Summary
Operate production equipment in Cell Culture, Purification, and Solution areas while performing routine and critical manufacturing activities under general supervision. Execute cGMP operations by completing batch records, logbooks, and form preparations, then enter and maintain accurate data in LIMS and MODA systems. Troubleshoot basic process issues, escalate deviations, and support equipment qualifications, validation activities, and continuous improvement initiatives. Work in a controlled environment requiring special gowning, with responsibilities including equipment assembly, cleaning, changeovers, and sample preparation.
Required Qualifications
- High school diploma
- 0-4 years related industry experience
- Associate's Degree in Life Sciences/Engineering field
- Biotech Certificate preferred
- 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
- 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
- Must be available for multiple shifts, including weekends, or supplemental hours, as necessary
- Must be able to work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body
- Must be able to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment
- Must be able to work in a cold, wet environment
- Must be able to work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
- Must be able to stoop or bending to check or trouble-shoot equipment operations
- Must be able to report to work for normal shift during inclement weather (e.g. snow storm) if management deems necessary
Desired Qualifications
- May be required to perform as a subject matter expert for equipment and/or systems
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