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

MacroGenics

Verified Company

Rockville, United States

3 weeks ago

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 Cell Culture 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

Participate in handson production in the manufacturing of material for clinical trials in a GMP environment, including operating expansion and production reactors, conducting harvest operations, and ordering and accounting for consumption of raw materials and components.
Contribute to the creation and revision of Batch Records, Work Instructions, Standard Operating Procedures, Material Specifications and other GMP documents
Adhere to all SOPs and execute batch records under GMP regulations documenting all manufacturing activities clearly and accurately, including preparation records, testing records, equipment use records, and laboratory notebooks
Maintain adequate supplies and perform routine equipment maintenance
Maintain manufacturing area in a clean, neat, and orderly condition at all times
Participate in a variety of projects designed to improve the quality, and efficiency of the manufacturing team
Follow all related safety rules and procedures when working with hazardous materials

Qualifications

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

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

Bachelor's degree in a related discipline with no experience
Manufacturing Associate II_
High School Diploma or equivalent and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

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

Bachelor's degree in a related discipline and a minimum of one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
Prior experience following GMP rules and procedures
Knowledge, Skills and Abilities_
Knowledge of cell culture techniques
Ability to write and revise technical documents
Ability to lift up to 30 lbs.
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