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Biological Manufacturing Associate

6 April 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 tissue processing, cell isolation and cell banking for use in further manufacturing and performs facility and equipment cleaning and operations. This position will spend a vast amount of time learning specific techniques and procedures in order to form a comprehensive understanding of processes and work flows. This position may support Manufacturing Development which requires technical writing and data analysis. This position works in the Clearwater, Florida office and will adhere to GMP guidelines and ensure 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.

  • Performs tissue dissection and enzymatic dissociation.
  • Performs cell counting and banking by cryopreservation.
  • Performs cleaning, maintenance, monitoring of the clean room, ancillary facilities, supplies, and equipment.
  • Maintains inventory of banked cells, components and supplies.
  • Performs and documents work in compliance with GMP, Quality Assurance and Quality Control standards, regulations and technical safety and internal procedures.
  • Reviews and updates existing Standard Operating Procedures, and authors new SOPs as assigned.
  • Documents all work in appropriate batch records, electronic databases, and forms or logs.
  • Performs duties for special projects as assigned.
  • Additional responsibilities may include equipment calibration, reading environmental plates, ordering/requesting inventory, and shipping of cells/product.
  • Supports training of new staff.

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 comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

REQUIRED QUALIFICATIONS

  • 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, bead baths
  • Use of liquid nitrogen cryo-storage equipment
  • Microsoft Office, Word and Excel
  • Algebra level math and basic statistical methods

BENEFICIAL QUALIFICATIONS

  • Working in a Biologic ISO 7, class 10,000, clean room environment
  • Experience working within Quality Systems
  • Proficient 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
  • Experience with technical writing and data trending

ATTRIBUTES OF SUCCESS

Active Learning Collaboration Detail Oriented Accountability Organization Interactive Communication

Critical Thinking Self Motivated Adaptability Multitasking Time management

WORK ENVIRONMENT/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 CLEARWATER

REPORTS TO MANUFACTURING ASSOCIATE DIRECTOR

MANAGES OTHERS NO

EDUCATION/YEARS’EXPERIENCE ASSOCIATE’S DEGREE WITH 3+ YEARS’ EXPERIENCE

BACHELOR’S DEGREE WITH 0+ YEARS’ EXPERIENCE

RELATED DEGREE PROGRAMS BIOLOGY, MICROBIOLOGY, BIOTECHNOLOGY

WORK EXPERIENCE REQUIREMENT GMP CONTROLLED THERAPEUTIC MANUFACTURING ENVIRONMENT

A combination of experience and/or education will be taken into consideration.

Noveome is an Equal Opportunity Employer.

Basic Information

Voluntary Self-Identification

Veteran Status

Gender

Ethnicity

Disability

Accommodation

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