Manufacturing Technician

Job Description

Job Description:Purifies proteins in a regulated FDA licensed and ISO certified facility and performs cross-functional activities associated with downstream production runs in collaboration with Bulk Fill and QC testing groups. The role may include special projects such as process development and validation activities where scientific research principles are applied.

Primary responsibilities:
Purify recombinant proteins to ensure commercial product demands are met:
1. Works as part of the purification team to perform purification, filtration, and centrifugation operations according to standard operating procedures.
2. Executes laboratory operations including dispensing of chemicals, volumetric and gravimetric measurements, making accurate dilutions, and preparing solutions.
3. Performs SAP duties that include cycle counting, reservations, issuing to process orders, and charging of expiring raw materials.
4. Performs equipment preventative maintenance tasks, column packing, and column testing procedures.
5. Ability to multi-task and become proficient at purifying 14 different proteins and make conjugates.
6. Responsible for ordering raw materials and components, as required.
7. Maintains a safe and well-organized work environment and complies with safety procedures.

Follow regulatory requirements:
1. Adheres to valid manufacturing procedures, manufacturing operations, and current good manufacturing practices (cGMP) and ISO requirements.

Documentation:
1. Responsible for the completion and review of batch records and logbooks, which requires legible, clear, and concise data entry.
2. Completes all training documentation within a pre-defined timeframe.

Analytical Testing:
1. Analyzes in-process samples generated from purification activities.
2. Operates lab equipment such as pH meters, balances, centrifuges, spectrophotometers, HPLC systems, and densitometers.
Skills:Must have an understanding of protein purification processes.
• Experience following and writing instructions.
• Very good verbal and written communication skills.
• Computer knowledge required with experience using MS Word and Excel.
• Able to document work accurately and has excellent organizational skills.
• Experience with preparation of reagents following instructions.
• Delivers quality products and services on time to all customers.
• Must be attentive to detail.
• Effectively manages time.
• Considers how all daily manufacturing activities impact product quality.
• Monitor processes and products to identify opportunities for continuous improvement.
• Able to lift and push up to 35 lbs.

1. Works well in a team environment to manufacture production lots.
2. Complies with cGMP and ISO requirements.
3. Maintains accurate documentation related to manufacturing processes.
Education:BA/BS in the sciences (Biology, Engineering, or related field) or 2 years of relevant experience
Languages:English Read Write Speak

Qualifications

Additional Information

Best Regards,Anuj Mehta
973-967-3402