Manufacturing Associate I

Job Description

Title : - Manufacturing Associate I

Location : Pearl River, NY

Duration : Contract until Oct 2026 (Possible extension after 1 year)

Downstream manufacturing role. GMP / Pharma manufacturing experience - must have at least one year. Aseptic / Gowned for 70%-80% of day. Must have good documentation for batch records. Potential for additional year extension.

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 downstream processing (Clarification and Purification) and buffer 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 all downstream processing equipment such as 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. Activities will include executing techniques such as large-scale centrifugation, depth filtration, chromatography column purification and packing, tangential flow filtration, and clean-in-place and steam-in-place of process equipment.

Other duties will include the cleaning and preparation of workspaces 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 turbidity meters). Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in downstream and buffer preparation 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 downstream and buffer preparation 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, 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.
• 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 :

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.

MINAKSHI SANGWAN

Recruiting Lead - US Recruitment

O 732-339-3518

E Minakshi.sangwan@aequor.com