Biotechnologist Associate

TalentBurst; Portsmouth (NH); On-site; USD 40,000 - 70,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Manufacturing Associate, der therapeutische Proteine unter cGMP-Bedingungen herstellt. In dieser spannenden Rolle sind Sie für die Ausführung von Prozessrezepten, die Überwachung von Geräten und die Durchführung grundlegender Laboraufgaben verantwortlich. Sie werden in einem dynamischen Umfeld arbeiten, das Ihnen die Möglichkeit bietet, Ihre Fähigkeiten in einem hochregulierten Bereich zu entwickeln. Wenn Sie eine Leidenschaft für die Herstellung von qualitativ hochwertigen Produkten haben und in einem Team arbeiten möchten, das sich der Exzellenz verpflichtet hat, dann ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Grundlegendes Verständnis von cGMP-Compliance und aseptischer Technik.
• Erfahrung in der Dokumentation und im Umgang mit Produktionsprozessen.

Responsibilities

• Einrichten und Überwachen von Produktionsprozessen in einer sauberen Umgebung.
• Dokumentation von Produktionsdaten gemäß GMP und GDP.

Skills

Aseptische Technik

Dokumentationsfähigkeiten

Mechanisches Verständnis

Computerfähigkeiten

Fähigkeit, SOPs zu befolgen

Job description

Job Title: Manufacturing Associate

Location: Portsmouth, NH, 03801

Duration: 12+ months

Shift: 12 HOUR SHIFTS - DAYS 7PM-7AM

Description:

The Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. Associates are expected to execute process recipes, follow written procedures (SOPs), monitor equipment and processes, perform basic laboratory tasks, including pH, conductivity, sampling, and conduct routine sanitization tasks to maintain facility and equipment. They are expected to attain a basic understanding of cGMP compliance while training under close supervision, demonstrating aseptic technique in handling of products and materials.

Responsibilities:

1. Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations.
2. Report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
3. Attain qualification for all assigned tasks and maintain individual training plan.
4. Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
5. Maintain facility and equipment through routine cleaning and sanitization, support 6S programs.
6. Must be willing to gown and work in a 'clean room' environment.
7. Perform administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects.
8. Perform other duties as assigned.

Successful Backgrounds:

Candidates with the following backgrounds have had success in manufacturing at Lonza:

1. Food service
2. Cooks (can follow recipes)
3. Pharmacy techs
4. Mechanical aptitude
5. Robotics
6. Computer skills (this is ever more important as our suites are more and more automated)
7. EMTs
8. Tech Support
9. Anything in which they need to follow SOPs, Guidelines, industry regulations
10. Sig Sauer employees
11. Security guards
12. Nurses/nurses aids