Manufacturing Associate, Downstream - Temporary and Full Time

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

Position Summary

The Manufacturing Associate will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific Fremont location. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide‑range of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The role will provide hands‑on execution of complex experiments in a team setting and support GMP and manufacturing activities.

Essential Duties and Responsibilities

• Execute complex unit operations in GMP manufacturing suites (chromatography, TFF, depth filtration, virus filtration, buffer preparation) under the oversight of qualified staff.
• Maintain and update training records in compliance with company policies.
• Support equipment troubleshooting, pilot‑scale material generation, and non‑GMP toxicology material generation.
• Author, review, and approve technical documents (tech‑transfer protocols, production batch records, training materials, manufacturing SOPs, regulatory filings) per project needs.
• Document work according to cGMP and cGDP, adhere to established regulations and cGMP standards.
• Maintain cleanroom standards, practices, and housekeeping according to SOPs.
• Identify minor equipment issues and notify leads/managers immediately.
• Contribute to quality activities such as investigations, area walk‑throughs, and authoring deviations, CAPA, and change control.
• Perform other duties as assigned, including flexible shift work.

Working Conditions

Position requires work in a laboratory/office setting. The role involves walking, standing, stooping, kneeling, crouching, and occasional lifting or moving up to 20 pounds independently.

Qualifications

• Associate degree with 1–2 years of relevant experience, or a combination of experience or advanced degree, preferably in biopharma manufacturing.
• Working knowledge of cGMP compliance and industry‑standard purification processes (affinity, IEX, SEC, viral inactivation, filtration, depth filtration, TFF, UFDF, etc.) and equipment.
• 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 simultaneously.

Compensation

The base compensation range for this role is between $25 and $30 per hour; actual compensation may vary depending on experience and qualifications.

Equal Opportunity

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other protected characteristic.