Manufacturing Associate IV

Job description

Overview

 

GENERAL SUMMARY OF POSITION: 

 

The Manufacturing Associate IV is responsible for manufacturing, assembling, and labeling of clinical and commercial biologic products.  Operate manual, semi-automated and automated production equipment.  Perform all functions under cGMP guidelines.

 

Responsibilities

MAJOR RESPONSIBILITIES:

 

  • Perform and may supervise manufacturing activities for a variety of clinical and commercial products which may include cell banking, bioreactor operation, purification, visual inspection, filling, packaging, and labeling
  • Perform manufacturing activities of licensed and clinical products in an aseptic environment
  • Perform autoclaving, cleaning and sterilization operations as needed
  • Ensure maintenance of records and logbooks
  • Tabulate data and prepare reports
  • Train personnel in manufacturing processes and ensure training records are up-to-date
  • Serve as liaison with other departments such as compliance, facilities, engineering, supply chain, and process development and quality groups
  • Executes and reviews records/documents and ensures compliance with cGMPs
  • Write SOPs, batch records, technical reports and other cGMP documents as required
  • Ensure media, glassware, equipment and other required items are ready for production
  • Participates in incident deviations and remediation
  • Propose production schedules to meet production needs and coordinates schedules during shut-down periods
  • Make recommendations in improving and streamlining production operations
  • Manage on-site inventory for day to day operations
  • Troubleshoot procedures and equipment. Collaborates with Mfg. Compliance to conduct root cause investigations of problematic manufacturing runs and makes recommendations to improve runs
  • Takes an active role in the organizational aspects of the Manufacturing department such as ordering and equipment repair
  • When required hires, manages and trains staff, plans and assigns duties to meet departmental and organizational objectives. Provides guidance and direction to staff; establishing expectations, defining roles, supporting career development and managing performance
  • Perform additional job related duties as required
Qualifications

REQUIRED QUALIFICATIONS:

 

  • Requires a bachelor’s degree in a scientific discipline, preferably biology
  • Minimum 7-9 years of relevant experience or equivalent
  • Experience in the following areas is required: aseptic manufacturing
  • Ability to follow instructions precisely, recognize deviations, and recommend corrective action
  • Prior experience in a cGxP cGMP regulated environment. Strong working knowledge of 21CFR
  • Demonstrated ability to train and supervise others
  • Ability to conduct complex troubleshooting
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems meet deadlines
  • Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
  • Demonstrated initiative through past experience

 

 

 

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Job No:
Posted: 10/14/2020
Application Due: 12/13/2020
Work Type:
Salary: