Manufacturing Associate III

Job Summary

The primary responsibility of the Manufacturing Associate III is to ensure the successful completion of cell therapy products. Ensure all processes and procedures are followed in full compliance with cGMP, CFRs and site quality systems, policies, and procedures. The MFG Associate III will be part of a cohesive team responsible for the quality manufacturing of our products.

General Responsibilities 

• Perform all tasks associated with the manufacturing of clinical drug product and follow the instructions described in standard operating procedures, protocols, test records, training records and batch records.
• Accurate and timely completion of documentation generated and required by protocols, test runs, training runs, standard operating procedures, and batch records.
• Accurate and timely review of documentation generated during manufacturing production.
• Adhere to tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Work as part of a dedicated and committed team to execute multiple cGMP production runs in close collaboration with support business units.
• Adhere and maintain aseptic technique practices during processing of products to ensure the integrity, viability, and sterility of finish drug product.
• Required to work in a cleanroom environment (ISO5/7) for prolonged periods of time; specialized gowning such as double gloves, hair net, masks, safety glasses, sterile coveralls and shoe covers.
• Ability to perform cell counting (manual/automated), perform error free calculations of cell concentrations, dilutions.
• Off hours or weekend work will be required at times depending upon the needs of the company.
• Be flexible and adaptable to production schedule needs, procedural changes, batch record enhancements to ensure timely production is met.  
• Assist MFG leads and Senior Associates with sustaining inventory levels of supplies and monitors and tracks trends to identify gaps.
• Proposes/lead continuous improvement projects.
• Initiate deviation investigations. 
• Drafts revisions of SOPs.
• Perform other duties as assigned.

*The company reserves the right to add or change duties at any time.

Job Qualifications & Skills 

• BS degree in relevant Science or Engineering discipline preferred, plus 2-3 years of experience in biotech/pharma. 
• AA degree in relevant Science or Engineering discipline, plus 4-5 years experiences in biotech/pharma.
• Expected to demonstrate expertise and breadth of knowledge on process flow and in executing a variety of production activities based on education, training, and hands-on production experience.
• Ability to trouble-shoot complex and non-routine equipment events, may initiate and assess deviations, review batch production records, and logbooks.
• Intermediate to Advanced level of experience in a biotech manufacturing setting preferred.
• Strong written and verbal communication skills are required.
• Strong attention to detail and ability to follow specific procedures and instructions.
• Supports validation efforts and assists in the authoring and implementation of Change Controls, Deviations, and CAPAs associated with manufacturing equipment, processes, and utilities. 
• Weekend work, holiday and/or Overtime maybe required.
• Capability to lift over 20lbs

*Candidates must be authorized to work in the U.S

Benefits & Perks

• Competitive compensation
• Medical, Dental and Vision Insurance
• Matching 401K
• Business casual work attire