Manufacturing Associate I

Job description

Overview

 

GENERAL SUMMARY OF POSITION:

 

Manufactures, assembles, and labels clinical and commercial biologic products. Operates manual and semi-automatic, and automated production equipment. Performs all functions under the cGMP guidelines.  

Responsibilities

MAJOR RESPONSIBILITIES:

  • Perform  manufacturing activities for a variety of licensed and clinical and commercial products which may include bioreactor operation, purification,  filling, packaging and labeling
  • Perform manufacturing activities of licensed and clinical products in an aseptic environment
  • Perform autoclaving, cleaning and sterilizationoperations as needed
  • Maintain records and logbooks
  • Assist in the tabulation of data and report generation
  • Serve as backup for routine EM activities
  • Assist in the training of manufacturing technicians
  • Prepare media and buffers and maintains the corresponding batch and solution records
  • Perform visual inspection of final product vials
  • Perform additional job related duties as required
Qualifications

REQUIRED QUALIFICATIONS:

  • Requires a bachelor’s degree in a scientific discipline, preferably biology with a minimum 0-2 years of relevant experience or equivalent
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
  • Ability to adapt to a cGxP regulated environment
  • Ability to troubleshoot within scope of training
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong time management and organizational skills
  • Demonstrated ability to multitask and consistently meet deadlines
  • Ability to apply scientific and technical principles to problem solving
  • Possesses  well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
  • Excellent written and verbal communication skills. Ability to communicate effectively with others
  • Demonstrated initiative through past experience
  • Ability to work effectively both independently and as a member of a team
  • Experience in the following areas is required: aseptic gowning
  • Experience in the following areas is preferred: manufacturing
  • No travel required, standard work hours may require weekend and off shift hours as required
  • Must be able to lift 50 lbs minimum using proper lifting technique

 

 

 

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Job No:
Posted: 9/9/2020
Application Due: 12/8/2020
Work Type:
Salary: