Manufacturing Associate

Position Description:

We are seeking a disciplined, energetic, and fast learning candidate to join our Manufacturing team as Manufacturing Associate I for a second shift.  Manufacturing Associate I is responsible for completing production orders in accordance with the daily production schedule. Job responsibilities include the manufacturing of biological reagents and finished products such as reagent formulations, antibodies conjugation, components lyophilization, and filling and assembly of final products. Experience working under ISO 13485 and/or current Good Manufacturing Practice (cGMP) in a biotechnology or pharmaceutical industry is highly preferred.

Work Schedule:

This position is for the following schedule: 10 am to 6:30 pm Thursday, Friday, Saturday, Sunday, and Monday. 

Second Shift Expectations:

• Minimal supervision is provided over the weekend; candidates must demonstrate experience working independently and making sound decisions in a manufacturing environment.
• Strong organizational skills and self-motivation are essential to maintain productivity and quality standards during off-hours.
• Effective communication skills to provide regular updates and document activities for review by weekday supervisors.
• Commitment to safety, quality, and continuous improvement, even when working independently.

Responsibilities:

• Perform standardized lyophilization of critical components for downstream manufacturing.
• Formulate biochemical and chemical reagents in accordance with manufacturing records, Standard Operating Procedures, and Quality System regulations.
• Support manufacturing activities such as filling and packaging, label printing, etc.
• Follow Good Documentation Practices to maintain detailed and accurate records for the manufacturing of reagents/products.
• Track inventory of consumables and raw materials. Perform routine cycle count to ensure inventory accuracy.
• Perform general laboratory maintenance such as basic equipment calibration and maintenance, general cleaning of facility, cleaning of labware, and routine laboratory housekeeping.
• Assist in troubleshooting of manufacturing issues.
• Participate in product validation for new product/processes introduction from R&D into Manufacturing.
• Participate in internal and external safety and quality inspections.
• Maintain a safe working environment and compliance with all safety laboratory practices.

Required Qualifications:

• A B.S. or B.A. degree in Biology, Chemistry, or equivalent.
• Minimum one year of relevant experience in reagents manufacturing with lyophilization experience highly desired.
• Must have demonstrated good biochemistry laboratory skills.
• Strong organizational skills, detailed oriented, and problem-solving skills.
• Must have demonstrated ability in following standard operating procedures and maintaining clear and accurate records.
• Experience working independently with minimal supervision, especially during weekend or off-hour shifts.
• Must be a strong team player, motivated, and willing to learn new techniques and concepts in a fast-paced environment.
• Experience in ISO 13485 and GMP environment a plus.
• Strong verbal and written communication skills.

Physical Requirement:

• Able to lift up to 25 lbs. 
• Position requires working in a standing position for long periods of time on a daily basis.

The base salary range for this full-time position is $72,000 - $85,000 + bonus + equity + benefits. Our salary ranges are determined by work location, job-related skills, experience, and relevant education or training. The ranges displayed on each job posting reflect the minimum and maximum target for new hire salaries but are subject to change if the leveling of the role is adjusted. Your recruiter can share more about the specific salary range during the hiring process.