Manufacturing Associate

Role Summary

The Manufacturing Associate will support manufacturing of Artiva’s off-the-shelf cell therapy platforms in our new, state of the art, cGMP facility. The successful candidate will develop and adhere to written procedures (SOPs) related to GMP facility operations, monitoring of equipment and facilities, and manufacturing of cell therapies internally at Artiva. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance and will support manufacturing activities across multiple programs.

Responsibilities

• Assist in setting up cGMP manufacturing suites and equipment/fixtures as needed.
• Perform facility and equipment monitoring activities.
• Assist in authoring manufacturing standard operating procedures and batch production records that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Perform cGMP manufacturing and support operations described in standard operating procedures and batch records across multiple programs.
• Complete documentation required by process tech-transfer protocols, validation protocols, standard operating procedures, and batch records following cGDP standards.
• Perform tasks in a manner consistent with Artiva’s safety policies, quality systems, and GMP requirements.
• Complete training assignments and qualifications to ensure the necessary GMP manufacturing, and process related technical skills and knowledge.

Qualifications

• Bachelor’s degree in relevant science or engineering discipline, or equivalent work experience.
• Minimum 2 years of experience in cGMP biologics or cell culture manufacturing, experience in biotech or cell therapy manufacturing preferred.
• Aseptic gowning and manufacturing in an ISO 7 clean room environment (preferred).
• Cell counting on various platforms (preferred).
• Cell culture and expansion using bag systems, single use large scale bioreactors, and others where applicable. Sartorius systems experience a plus.
• Experience with transduction using Lentiviral vectors (preferred).
• Cell harvesting and washing processes both automated and manual. Experience with kSep a plus.
• Cell selection and depletion techniques using Miltenyi CliniMACS Prodigy (preferred).
• Fill finish and Cryopreservation processes and equipment in both bags and vials. AT-vialing a plus.
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

Skills

• Strong documentation and record-keeping abilities.
• Ability to work in a fast-paced, GMP-regulated environment.
• Strong attention to detail and adherence to SOPs and batch records.

Education

• Bachelor’s degree in a relevant science or engineering discipline or equivalent work experience.

Additional Requirements

• Will require working with cells and cell lines of human origin as well as viral vectors.
• Position may require occasional weekend or evening work at Artiva.