Manufacturing Associate I

Position

We are seeking a disciplined, highly motivated, and results driven Manufacturing Associate I to join our Operations team. Qualified candidate will be responsible for the manufacturing of biological reagents and finished products. Experience in reagent formulations under good manufacturing practice (GMP) and good documentation practice (GDP) in a regulated industry are highly preferred.

Responsibilities

• Execute manufacturing formulations in accordance with manufacturing batch records (MPRs), standard operating procedures, and other applicable Quality System policies.
• Perform standardized antibodies dispensing and support lyophilization of critical components for downstream manufacturing.
• Assist in other areas of manufacturing deemed high priority such as special builds, filling and packaging etc.
• Follow good documentation practices to maintain detailed MPRs in manufacturing.
• Track and maintain inventory of consumables and raw materials required for manufacturing.
• Participate in general laboratory maintenance such as basic equipment calibration and maintenance, general cleaning of facility, cleaning of labware, and routine laboratory housekeeping.
• Support troubleshooting to investigate and resolve manufacturing issues.
• Support routine inventory cycle count.
• May participate in product validation for new product/processes introduction from R&D into Manufacturing.
• Maintain a safe working environment and in compliance with all safety laboratory practices.

Required Qualifications:

• A B.S. degree in Biological Science or Engineering with 1 to 2 years of experience in reagent manufacturing and/or quality control.
• 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 manufacturing and quality control records.
• Must be a strong team player, self-motivated, and willing to learn new techniques and concepts in a fast-paced environment.
• Able to work under minimal supervision to deliver expected results.
• Experience in ISO 13485 and GMP environment a plus.
• Previous experience with ERP System preferred.
• 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 $25/hour - $35/hour + 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.