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Biological Manufacturing Associate I

9 September 2021

ABOUT NOVEOME BIOTHERAPEUTICS, INC.
Noveome Biotherapeutics, Inc. is a dynamic biopharmaceutical company with an innovative platform technology that represents a paradigm shift in drug development. Unlike most drugs that are single molecules directed at specific indications, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to treat a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.

 

POSITION OBJECTIVE
The Biological Manufacturing Associate I performs cell culture, product collection and filtration for use in finished product manufacturing. This position has responsibility for facility and equipment cleaning and operations. This position will spend a vast amount of time learning specific techniques and processes in order to function in this position. This position will adhere to GMP guidelines and processes are compliant with FDA CFR part 210-211.

 

WHAT YOU WILL DO FOR NOVEOME
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Manufactures cell based products using banked primary cells
• Seeds and maintains small and large scale bioreactor cell cultures
• Performs cell thaw, count, harvest, and banking
• Performs product filtration
• Performs cleaning, maintenance, and monitoring of the clean room facility and equipment
• Assists with inventory of banked cells, cell based products, components, and supplies
• Performs and documents work in compliance with GMP, Quality Assurance, and Quality Control standards, regulations and technical safety procedures
• Participates in review of Standard Operating Procedures
• Documents all work in appropriate batch record, form or log
• Performs duties for special projects as assigned
Please note, as a company rooted in innovation, our positions are consistently evolving and we champion the development of all roles. This job description is not designed to contain a comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

 

WHAT YOU NEED TO KNOW
• Aseptic technique
• Handling of human tissue and cell specimens
• Large and micro volume pipetting
• Basic light microscopy and cell counting methods
• Use of centrifuges, refrigerators, freezers, incubators, balances, peristaltic pumps and mixers
• Use of liquid nitrogen cryo-storage equipment
• Microsoft Office, Word and Excel, Algebra level math and basic statistical methods
WHAT COULD SET YOU APART FROM THE COMPETITION
• Experience working in a Biologic ISO 7, class 10,000, clean room environment
• Experience with Bioprocess filtration, viral clearance methods
• Experience with Quality Systems
• Experience with electronic inventory and documentation databases
• Compliance with FDA CFR part 210-211 cGMP in manufacturing, processing, packing, or holding of drugs and finished pharmaceuticals

 

ATTRIBUTES OF SUCCESS
Active Learning Collaboration Detail Oriented Accountability Organization Interactive Communication
Critical Thinking Self Motivated Adaptability Multitasking Time management

 

PHYSICAL DEMANDS
Works in a GMP biologics clean room with gowning requirements as well as in a business office setting. Characterized as medium work that involves standing and sitting for periods of time. May require carrying, holding, lifting, pushing, and pulling up to 30 lbs. Other activities may include talking, hearing, typing, visual acuity, and writing. Will work in an environment with odors that may be inhaled, works with hazardous chemicals and in close proximity of machines with moving parts.

 

REGULAR SCHEDULE
This is a non-exempt full-time position with a regular schedule of Monday through Friday work hours. Extended hours may be needed on occasion to complete company objectives. This position requires the incumbent to be physically present onsite.

 

WHAT NOVEOME WILL DO FOR YOU
Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks.

 

LOCATION PITTSBURGH
REPORTS TO MANUFACTURING SUPERVISOR
MANAGERS OTHERS NO
EDUCATION REQUIREMENTS ASSOCIATE’S OR BACHELOR’S DEGREE
RELATED DEGREE PROGRAMS BIOLOGY, MICROBIOLOGY, BIOTECHNOLOGY
YEARS EXPERIENCE REQUIREMENTS 0+ YEARS’ EXPERIENCE
CERTIFICATION REQUIREMENTS NONE
A combination of experience and/or education will be taken into consideration.
Noveome is an Equal Opportunity Employer.

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