Manufacturing Associate ; Manufacturing​/Quality 1st Shift

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 media, buffer and solution preparation areas of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties will include the operation, maintenance, cleaning and sanitization of media and buffer equipment such as stainless‑steel mix tanks including transfer lines, standalone mixing units, use of water‑for‑injection (WFI) point‑of‑use taps.

Other duties will include the cleaning and preparation of work spaces and biosafety cabinets. The incumbent should be proficient in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in‑process testing equipment (pH / conductivity meters and osmometers). Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in the media, buffer and solution preparation areas.

Business needs may also require cross training and operations in flex areas.

• In depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of media, buffer and solution formulation including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), weighing and dispensing of raw materials and intermediate solutions, material sampling for applicable analytical testing, filter integrity testing, etc.
• Responsible for the operation and maintenance of ancillary equipment such as pH / conductivity meters, osmometer, 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.
• 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.

• 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.
• Good communication and social skills.
• Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required.

Requires physical demands of lifting 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.

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.