USA - Manufacturing Associate I (Manufacturing/Quality) 1st Shift (contract)

Sanofi; Pearl River (NY); On-site; USD 40,000 - 65,000; Full time

Job summary

Ein etabliertes Unternehmen in der Pharmaindustrie sucht einen engagierten Manufacturing Associate I für eine 10-monatige Vertragsposition. In dieser Rolle sind Sie verantwortlich für die Ausführung von Standardverfahren zur Herstellung von Arzneimitteln in einer cGMP-Umgebung. Ihre Aufgaben umfassen die aseptische Zellkultur, die Vorbereitung von Virusbeständen sowie die Bedienung eines 100L Bioreaktors. Wenn Sie eine Leidenschaft für die pharmazeutische Herstellung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 2 Jahre Erfahrung in einer cGMP-Umgebung oder relevante Schulung.
• Kenntnisse über cGMP, GDP und SOPs.

Responsibilities

• Ausführung von SOPs und Batch-Aufzeichnungen in der Zellkultur.
• Vorbereitung von Virusbeständen in Flaschen und Bioreaktoren.

Skills

Aseptische Techniken

Zellkultur

Dokumentationspraktiken

Kommunikationsfähigkeiten

Education

High School Diploma

Tools

Zellzähler

Mikroskop

Bioreaktor

Job description

USA - Manufacturing Associate I (Manufacturing/Quality) 1st Shift (contract)

Join to apply for the USA - Manufacturing Associate I (Manufacturing/Quality) 1st Shift (contract) role at Sanofi.

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Manufacturing Associate I for a 10-month contract.

Description

POSITION OVERVIEW:

The primary responsibility of the incumbent will be executing standard operating procedures (SOPs) and batch records in the production of Flublok Drug Substance within the dedicated Cell Culture area of the cGMP manufacturing facility. This involves cell maintenance, virus stock generation, and aseptic techniques.

Responsibilities include aseptic cell culture sampling, cell splitting, virus stock preparation, cell scale-up, equipment cleaning, setup and operation of a 100L single-use bioreactor, and troubleshooting in the cell culture area.

Responsibilities

• Execute routine techniques and processes related to insect cell culture maintenance and scale-up.
• Generate virus stock in flasks and bioreactors, using ancillary equipment.
• Perform cell analysis using a cell counter and microscope.
• Collaborate with other departments to resolve manufacturing quality issues.
• Manage and analyze manufacturing data.
• Maintain good documentation practices (GDP).
• Complete required cGMP training.
• Participate in cleaning and sanitation of the cGMP facility.
• Follow SOPs for material, personnel, and equipment flow.
• Work flexible schedules, including weekends and holidays as needed.
• Notify deviations and CAPAs to Compliance and assist in investigations.

Requisite Education/Skills

• High School diploma with at least 2 years of experience in a cGMP environment or relevant training.
• Knowledge of cGMP, GDP, and SOPs.
• Fluent in English, both written and spoken.
• Good communication and social skills.
• Understanding of BEVS manufacturing process is a plus but not required.

Additional Details

• Seniority level: Entry level
• Employment type: Contract
• Job function: Research, Analyst, and IT
• Industry: Pharmaceutical Manufacturing