Associate Manufacturing Operations

Mix Talent; Cleveland (OH); On-site; USD 50,000 - 90,000; Full time

Job summary

Ein dynamisches Unternehmen im Bereich Zell- und Gentherapie sucht einen Manufacturing Operations Associate in Cleveland. In dieser spannenden Rolle sind Sie verantwortlich für die Durchführung von cGMP-Prozessen und die Unterstützung mehrerer Produktpipeline-Initiativen. Sie werden Teil eines engagierten Teams, das sich mit der Herstellung von retroviralen Vektoren und autologen gentherapeutischen Zellen beschäftigt. Ihre Aufgaben umfassen die Durchführung von Zellkulturtechniken, die Optimierung von Prozessen und die Dokumentation. Wenn Sie eine Leidenschaft für Biologika haben und in einem schnelllebigen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• 2-4 Jahre Erfahrung in der GXP-Produktion oder 1-2 Jahre mit einem MS-Abschluss.
• Erfahrung mit Zelltherapien und/oder viralen Vektoren ist hochgradig bevorzugt.

Responsibilities

• Durchführung von cGMP-Prozessen und Unterstützung bei der Prozessoptimierung.
• Zellkulturtechniken wie Zellpassage und Mikroskopie durchführen.

Skills

Aseptische Techniken

Zellkulturtechniken

Projektmanagement

Kommunikationsfähigkeiten

Organisationsfähigkeiten

Education

BS in wissenschaftlicher Disziplin

MS in wissenschaftlicher Disziplin

Tools

Microsoft Office

Job description

Cell and Gene Therapy company is looking for a Manufacturing Operations Associate to join the team in Cleveland, OH. The successful candidate will be responsible for Manufacturing initiatives supporting multiple product pipelines. The candidate will be an integral part of a fast-paced group responsible for the manufacture of retroviral vector and autologous gene-corrected cell therapies. Responsibilities will include executing protocols and manufacturing clinical and commercial material across multiple products as well as supporting process optimization work and document generation. The ideal candidate will have experience in production of biologics in a controlled cGXP setting. Strong aseptic and cell culture technique as well as collaborative work in a team is an integral part of this position.

Essential Duties and Responsibilities:

• Performs cGMP processes within the manufacturing facility in conjunction with manufacturing production records (MPRs) and operates within written procedures.
• Execute studies in support of process optimization and validation.
• Performs cell culture techniques including cell passaging, microscopy, and cell observation.
• Performs retroviral vector transduction and production of retroviral vector.
• Maintains compliance by completing ongoing training.
• Author, review, and provide technical support for manufacturing SOPs, MPRs, and other documents.
• Maintains manufacturing and laboratory equipment through preventive maintenance and routine cleaning.
• Identify, suggest, and manage projects in parallel with manufacturing activities to reach set goals.
• Ability to collaborate with others while maintaining a strong capability in independent, critical thought.
• Strong organizational skills required.
• Must be able to work as part of a team.
• Contribute to activities that support safety and/or lab infrastructure.

Qualifications:

• BS or equivalent in scientific discipline and min of 2-4 years related lab or GXP production experience or MS or equivalent with 1-2 years of experience.Experience with mammalian and/or insect cell culture technology.
• Experience with production processes for cell therapies and/or viral vectors or vaccines is highly preferred.
• Familiarity with aseptic technique and cell culture is strongly preferred.

Other Skills and Abilities:

• Advanced communication and organizational skills.
• Advanced interpersonal skills and the ability to work with individuals across all organizational levels.
• Attention to detail and accuracy.
• Detailed record keeping and data documentation.
• Demonstrated project management skills.
• Ability to read, analyze, and interpret technical procedures, publications, intellectual property and/or government documents.
• Working knowledge of GLP, GDP, GCP, and GMP regulations and their ISO counterparts and ICH Guidelines.
• High level of proficiency with Microsoft Office programs.
• Less than 10% travel. Any travel will be reimbursed in accordance with company policy

Physical Demands:
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Hand-eye coordination and manual dexterity sufficient to operate office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting of up to 50 pounds is required.