Manufacturing Associate II (Upstream)

MANUFACTURING ASSOCIATE II (UPSTREAM)

Location - Vacaville, CA (Onsite)

Reports to -Manufacturing Manager, Upstream

Job Type - Full-time

FLSA - Non-Exempt

Company Overview

Polaris Pharmaceuticals, part of Polaris Group, is a multinational biotechnology company focused on the discovery, development, and manufacturing of innovative therapies, with a primary focus on oncology. The company’s lead therapeutic candidate, pegargiminase (ADI-PEG 20), is currently in late-stage clinical development across multiple cancer indications.

Polaris operates across the full drug development lifecycle, from research and clinical development to cGMP manufacturing. With facilities in the United States and Asia, the company combines scientific innovation with integrated development and manufacturing capabilities to advance therapies for patients worldwide.

Job Summary

The Manufacturing Associate II (Upstream) supports cGMP manufacturing operations for biologics production. This role executes upstream processing activities including cell culture, fermentation, media preparation, filling and related cleanroom operations. The position works closely with MSAT, Quality, and Facilities/Engineering teams to ensure safe, compliant, and efficient production of drug substances and intermediates. The successful candidate will operate in a cGMP cleanroom environment, follow standard operating procedures (SOPs), and maintain accurate documentation in accordance with Good Documentation Practices (GDP). The role will support ongoing commissioning and validation activities and will provide overall manufacturing operations support that includes yet is not limited to; equipment testing, SOP/batch record generation, and validation protocol execution support. The role will be responsible for executing a combination of engineering and GMP clinical batches with supporting staff. The manufacturing II role will be an integral contributor tasked with building a diverse and technically strong team for future successful GMP operations.

Key Responsibilities

• Execution of upstream manufacturing operations (e.g., media preparation, cell culture/fermentation, harvest, cell lysis, and filtration)
• Assist with the installation, commissioning, and validation of equipment within the facility.
• Operation, cleaning, and maintenance of manufacturing equipment.
• Raw material preparation and dispensing.
• Collection of in-process samples for QC testing.
• Participation in validation or engineering runs as needed.
• Accurate documentation in batch records and logbooks in compliance with cGMP.
• Initiation and support of deviations investigation, CAPA, and change control activities.
• Cross-functional collaboration with Quality, MSAT, Facilities, and Engineering teams.
• Assist/write SOPs (standard operating procedures), batch records, and other GMP documentation.
• Display ability to identify and escalate potential GMP issues, as required.
• Available to participate in flexible shifts (Day, Swing, Weekends, Holidays) as directed by the facility start up and future production schedules.

Required Qualifications

• Associate or Bachelor’s degree in biology, biotechnology, engineering, or related scientific discipline.
• Minimum of 2 years of experience in GMP or biopharmaceutical manufacturing.
• Knowledge of cGMP manufacturing and documentation practices.
• Strong communicator with ability to work effectively both independently and as part of a team.
• Adhere to manufacturing procedures and documentation as well as identifying clarifications or updates when required.
• Maintain a high level of quality and compliance with regards to all aspects of manufacturing.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• Experience working in a cleanroom or aseptic manufacturing environment preferred.
• Experience with upstream processes such as cell culture, fermentation, or media preparation.
• Experience with continuous improvement platforms and history of identifying changes with positive impact to safety, product quality, and/or operational efficiency.
• Ability to clearly define events and associated process conditions during nonconformance or safety escalation efforts.
• Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities.
• Knowledge of Trackwise, LIMS, PI data preferred.

Physical / Work Environment

• Ability to work in a cleanroom environment and qualify for aseptic gowning.
• Ability to stand for extended periods and perform repetitive tasks.
• Ability to lift approximately 25–40 lbs.
• Ability to wear required PPE including gowning, gloves, and masks.
• This is an on-site role working in a cGMP regulated manufacturing facility.

Salary Range

• The compensation range for this position is $30–$35 per hour, depending on experience and qualifications.

Benefits

Polaris Pharmaceuticals offers a comprehensive benefits package, which may include:

• Medical, dental, and vision insurance
• 401(k) retirement plan
• Paid time off and company holidays

Equal Employment Opportunity Statement

Polaris Pharmaceuticals is an Equal Opportunity Employer. We are committed to building a diverse and inclusive workplace and do not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable federal, state, or local laws.