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Upstream Production Associate

GENERAL DESCRIPTION/FUNCTION:

This role is responsible for supporting the overall GMP cell culture manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II GMP manufacturing.

Lifting up to 40 lbs., unassisted may be required at times.
Shift work and/or weekend work may be required at times

Duties & Responsibilities:

Support GMP Manufacturing including:

May act as shift leader during operation of cell culture processes (media/buffer prep, seed prep, culturing, harvest equipment and CIP)
Generating internal or external documents (SOPs, BRs)
Taking the lead role in troubleshooting process and equipment problems
Recommending equipment, supply purchases within the production areas
Developing creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
May work in Process Development to transfer production projects into GMP Production
Working closely with production management to initiate new manufacturing projects and help develop processes/techniques to meet contract objectives
Working closely with various departments and offers assistance as needed
Interacting with clients during initial and subsequent manufacturing campaigns
Participating in facility expansion and equipment validation
Assisting management with GMP and Safety training of manufacturing staff
Other duties as assigned

Skills & Technical Expertise:

Have excellent understanding and knowledge of cell culture techniques and processes
Experienced in using disposable single-use bioreactors (WAVES, Xcellerex)
Extensive experience in producing Master and Working cell banks
Experience and a thorough understanding in coordination of manufacturing activities with other departments (QA, QC) to maintain internal and project schedules
Ability to produce results in a fast-paced environment, under minimal supervision while leading junior staff
Able to work in a team setting and independently under minimum supervision
Creative individual with excellent trouble shooting skills

Supervision:

May act as lead in operation of cell culture processes
Work independently under general supervision to meet company goals

Measurement of Performance:

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
Timeliness and accuracy in completion of projects and paperwork (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Offers suggestions for correcting problems and for improving operations
Exercises good judgment in dealing with operational problems
Understanding of theory, rationale behind tasks performed
Demonstrated understanding and adherence to policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions

Education and Previous Experience:

High School Diploma plus 7+ years of experience in cell culture production (mammalian, insect) – OR –
BS in a Life Sciences discipline and 4+ years of relevant experience – OR – MS in a Life Sciences discipline and 2+ years of relevant experience
Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work with cell culture reactors and with processes to produce bulk biologics (proteins, antibodies, etc.)
Have the knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
Well-versed in Good Manufacturing Practices (GMPs)
Mature professional capable of independent work

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