Manufacturing Associate I

Job Title: Manufacturing Associate I
Job Location: Pearl River, NY
Job Duration: 12+ Months

Pay Range: $24-$26/hr 

Shift- 1 st - Mon - Fri 7am to 330pm

POSITION OVERVIEW:
Primary responsibility of the incumbent will be operation of general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the large-scale recombinant protein production operations of the cGMP commercial manufacturing facility.
Requires good documentation skills and attention to detail. Duties will include the operation, maintenance, cleaning and sanitization of large-scale cell culture bioreactors and associated operations such as media preparation, infection and harvest. Activities will include executing techniques such as large-scale bioreactor cell expansion with the use of stainless-steel vessels including transfer lines, ancillary equipment (tube welders, tube sealers, peristaltic pumps), use of water-for-injection (WFI) point of use taps, etc.

Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. Proficiency in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (cell analyzer, microProduct) required. The incumbent should have the ability to identify, troubleshoot and participate in the resolution of operational and equipment problems as they arise in the large-scale Bioreactor and Media Preparation areas with minimum supervision and effective communication to management.

Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in the assigned areas. Business needs may also require database entry, cross training and operations in flex areas.


RESPONSIBILITIES:
• In depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of large-scale bioreactor cell expansion and protein production including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), material sampling for applicable analytical testing, filter integrity testing, etc.
• Perform cell analysis and data interpretation of cell culture samples with the use of the cell counter, including operation of microProduct for contamination checks.
• Responsible for the operation and maintenance of ancillary equipment such as floor scales, turbidity meters, tube welder, tube sealer, peristaltic pumps, etc.
• Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
• Technician should have the ability to manage and analyze manufacturing data.
• Ability to take initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
• Ability to present and explain techniques and results of manufacturing processes with outside departmental personnel.
• Ensure good documentation practices (GDP) in execution and reviews of production records.
• Responsible for all required cGMP training including additional training assigned by their manager.
• Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
• Follows established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
• Work a flexible work schedule, weekends and holidays as required, and as needed by department.
• Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.
• Other duties as they are required.

REQUISITE EDUCATION/SKILLS:
• High School degree with at least 2 years of work experience, or training within a cGMP manufacturing environment
• General knowledge of cGMP, GDP, SOP’s
• English fluent, both written and spoken
• Good communication and social skills
• Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job and include the ability to stand over intervals of several hours at a time, ability to bend, squat, and reach, and ability to lift, push, or pull various amounts of weight up to approximately 50 lbs. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May involve work with hazardous materials.

Based on production schedules, different start time scenarios may occur, requiring a flexible work schedule for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including 2nd shift or split shift hours, extended day hours and weekends. This role requires frequent work on weekends depending on production demands.