Manufacturing Associate I/ii - Rockville, United States - MacroGenics

MacroGenics
MacroGenics
Verified Company
Rockville, United States

3 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development.

MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.


Summary of Position


The Manufacturing Associate I/II participates in the manufacturing of biopharmaceutical drug product to support MacroGenics' multiple clinical programs in the Protein Purification area.

This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) to ensure that materials manufactured meet required specifications and regulatory requirements.


Responsibilities and Job Duties

  • Participates in handson production in the manufacturing of commercial and clinical material in a GMP environment.
  • Performs purification operations including filtration, chromatography, titrations, column packing, Tangetial Flow Filtration (TFF) and bulk fill.
  • Consumes and scraps solutions, raw materials, consumables and components in SAP.
  • Contributes to the creation and revision of Batch Records, Standard Operating Procedures, Material Specifications, and other GMP documents.
  • Adheres to all SOPs and batch records under GMP regulations to document all manufacturing activities clearly and accurately.
  • Maintains adequate supplies to perform routine equipment maintenance.
  • Maintains manufacturing area in a clean, neat, and orderly condition at all times.
  • Participates in a variety of projects designed to improve the quality, and efficiency of the manufacturing team.
  • Follows all related safety policies and procedures when working with hazardous materials.

Qualifications

  • Manufacturing Associate I_
  • Education & Experience_
  • High School Diploma or equivalent with exposure to science and math coursework and a minimum of two years of related related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
OR

  • Associate degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
OR

  • Bachelor's degree in a related discipline with no experience
  • Manufacturing Associate II_
  • Education & Experience_

Qualifications

  • Education & Experience_
  • High School Diploma or equivalent and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.
OR

  • Associate degree in a related discipline and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.
OR

  • Bachelor's degree in a related discipline and a minimum of one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.
  • Knowledge, Skills and Abilities_
  • Knowledge of protein purification techniques.
  • Ability to write and revise technical documents.
  • Ability to work occasional weekends or overtime as needed.
  • Ability to follow detailed instructions and to maintain accurate records.
  • Ability to work effectively in a team environment.
  • Ability to successfully perform multiple tasks, when required.
  • Skills in problemsolving and troubleshooting.
  • Ability to safely operate production equipment in accordance with established procedures.
  • Ability to lift up to 30 lbs.

Supervisory Responsibilities
None

  • Knowledge, Skills and Abilities_
  • Knowledge of protein purification techniques
  • Ability to write and revise technical documents
  • Ability to lift up to 20 kg
  • Ability to work occasional weekends or overtime as needed
  • Ability to follow detailed instructions and to maintain accurate records and notes
  • Ability to work effectively in a team environment
  • Ability to successfully perform multiple tasks, when required
  • Skills in problem solving and troubleshooting
  • Ability to safely operate production equipment in accordance with established practices

Supervisory Responsibilities
None


Preferred Qualifications

  • Previous GMP experience
  • Ability to use Microsoft Office (Word, Excel)

Statement
**Equal Opportunity Employer/Veterans/Disabled
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