Manufacturing Associate Level 3
On-site · Portsmouth, New Hampshire, United States
Job Summary
Manufacturing Associate III responsible for operating, monitoring, and troubleshooting upstream bioprocessing equipment to support GMP-compliant production of therapeutic proteins. Performs CIP/SIP and production processes following SOPs, cGMP, and GDP; conducts advanced lab tasks such as sampling, pH, and conductivity testing; reviews batch records and supports deviation initiation; trains and supports other associates on manufacturing tasks and process knowledge; and maintains equipment through cleaning and sanitization. Requires 3+ years of upstream bioprocessing experience (5+ years preferred) with strong GMP knowledge, technical writing, and problem-solving skills. This is an onsite, 12-hour night shift position on a rotating schedule, at Lonza’s Portsmouth site, focusing on quality, safety, and continuous improvement within a collaborative team.
Required Qualifications
- 3+ years of upstream bioprocessing experience required
- Experience in GMP manufacturing or a regulated biopharmaceutical environment
- Strong understanding of cGMP, documentation practices, and process flow
- Ability to troubleshoot equipment and support investigations
- Attention to detail with strong problem-solving and decision-making skills
Desired Qualifications
- 3+ years of upstream bioprocessing experience
- 5+ years in the biotech industry preferred
- Experience in GMP manufacturing or a regulated biopharmaceutical environment
- Strong understanding of cGMP, documentation practices, and process flow
- Ability to troubleshoot equipment and support investigations
- Strong communication skills, including technical writing
- Attention to detail with strong problem-solving and decision-making skills
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