Chemistry Manufacturing Lab Technician

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Title

Chemistry Mfg Technician I

Schedule

1st shift, M-F

Description

The Technician will be responsible for preparing small-scale and large scale buffers to support internal manufacturing operations as well as product sales. Additional responsibilities include performing a variety of production support activities such as running SDS-PAGE and IEF gels, executing ELISA assays, and conducting mycoplasma testing as needed. The ideal candidate will have experience performing buffer preparation calculations, sterilizing liquids, and operating autoclaves. Routine duties will also include washing and sterilizing glassware, maintaining the buffer preparation area, monitoring inventory levels, ordering chemicals and supplies, and completing accurate and compliant batch records.

As a key member of the Manufacturing team, this individual will collaborate closely with Tissue Culture, Purification, Conjugation, Inventory Control, BMIA, MCI, Process Development, Purchasing, and Planning groups. The successful candidate will support buffer manufacturing and additional production tasks as required.

The ideal candidate is a reliable team player who is highly organized, detail-oriented, and able to communicate effectively both verbally and in writing. The position requires the ability to multitask, work independently, and perform in a fast-paced environment while consistently meeting deadlines.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prepare small- and large-scale buffers and reagents following established batch records.
• Perform buffer preparation calculations, pH adjustments, and filtration steps.
• Sterilize liquids and operate autoclaves; wash and sterilize glassware.
• Maintain the buffer preparation room, ensuring cleanliness and compliance with GMP standards.
• Run SDS-PAGE and IEF gels.
• Perform ELISA assays and mycoplasma detection assays when required.
• Complete accurate and compliant batch records and logbooks.
• Monitor inventory of chemicals, consumables, and supplies; initiate orders as needed.
• Support additional manufacturing or lab operations as directed.
• Other projects or responsibilities may be required.

Minimum Qualifications

• Associate's Degree in Biology, Biochemistry, Chemistry, or other related area.
• 0-6 months of relevant experience in a laboratory and/or biotech manufacturing working environment.
• Demonstrated ability to be detail-oriented, organized, work well independently and in small work groups and the ability to adhere to timelines.
• Knowledge of Good Documentation Practices.
• Knowledge of aseptic techniques in biosafety cabinet.
• Ability to pipette small and large volumes.
• Ability to perform simple math calculations.
• Ability to communicate effectively both orally and in writing.

Preferred Qualifications

• 2 years of relevant experience in a laboratory and/or biotech working environment.
• Working experience in Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.
• Advance pipetting skill is highly preferred.
• Familiar with raw material supply receiving and inspection process.

Required Skills

• Buffer preparation
• Buffer preparation calculations
• pH adjustments
• Filtration
• Operating autoclaves

Preferred Skills

• Sterilizing liquids
• Washing glassware
• Sterilizing glassware
• Maintaining buffer preparation area
• GMP compliance
• SDS-PAGE
• IEF gels
• ELISA assays
• Mycoplasma detection assays
• Batch record completion
• Logbook completion
• Inventory monitoring
• Chemical ordering
• Consumable ordering
• Supply ordering
• Aseptic techniques
• Pipetting small volumes
• Pipetting large volumes
• Simple math calculations
• Effective oral communication
• Effective written communication
• ISO 13485 knowledge
• cGMP regulation knowledge
• Raw material supply receiving
• Raw material inspection