GMP Purification & Tech-Transfer Associate

Bionova Scientific LLC; United States; On-site; USD 34,440 - 41,328; Full time

Job summary

Bionova Scientific LLC in Fremont seeks a Manufacturing Associate to join the Purification/Manufacturing group, supporting GMP manufacturing and tech transfers. You will perform hands-on experiments and help implement processes, working within cross-functional teams to meet project goals.

The role requires 1–2 years of related experience, familiarity with cGMP standards, and the ability to manage multiple tasks while maintaining training records and documentation.

Qualifications

• Associate degree with 1–2 years of relevant experience in biopharma manufacturing.
• Working knowledge of cGMP compliance and purification processes.
• Experience with process monitoring software and equipment software (UNICORN, Pi Historian).
• Creative thinker capable of identifying more efficient solutions.
• Demonstrated ability to work independently and cross‑functionally.
• Ability to prioritize assignments and manage multiple projects.

Responsibilities

• Execute complex unit operations in GMP manufacturing suites (chromatography, TFF, depth filtration, virus filtration, buffer preparation).
• Maintain and update training records in compliance with policies.
• Support equipment troubleshooting, pilot-scale material generation, and non-GMP toxicology material generation.
• Author, review, and approve technical documents per project needs.
• Document work according to cGMP and cGDP; adhere to regulations and standards.
• Maintain cleanroom standards and housekeeping according to SOPs.
• Identify minor equipment issues and notify leads/managers.
• Contribute to quality activities such as investigations and deviations.
• Perform other duties, including flexible shift work.

Skills

cGMP knowledge

Cross-functional work

Prioritization

Independent worker

Analytical thinking

Education

Associate degree

Tools

UNICORN

Pi Historian

Job description

Bionova Scientific LLC in Fremont seeks a Manufacturing Associate to join the Purification/Manufacturing group, supporting GMP manufacturing and tech transfers. You will perform hands-on experiments and help implement processes, working within cross-functional teams to meet project goals.

The role requires 1–2 years of related experience, familiarity with cGMP standards, and the ability to manage multiple tasks while maintaining training records and documentation.