Manufacturing Associate III, Drug Product/Fill Finish - Lexington, MA

    • Job Tracking ID: 85430-279585
    • Job Location: Lexington, MA
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: 01/23/2019
    • Years of Experience: Not Applicable
    • Starting Date: ASAP
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Job Description

Position Description/Summary

Responsible for cGMP manufacturing operations at the Brammer Lexington site Drug Product (DP) Fill/Finish operations.

Responsibilities include:

  • Performing basic to complex activities on the fill finish line for production of Drug Product.
  • Performing critical downstream activities in preparation for fill finish of Drug Product.
  • Documentation of all activities in Batch Records, Logbooks, Forms, Etc.
  • Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
  • Identifies, escalates and documents events and subtle variances that deviate from normal operation; participate as needed in investigations.
  • Monitor processes using automated production systems and controls with limited supervision.
  • Equipment preparation activities including, parts cleaning, autoclaving, and room clearance.
  • Demonstrates ability to troubleshoot basic mechanical operations.
  • Post-Fill tasks will include visual inspection, secondary packaging, and environmental monitoring.
  • Daily Aseptic processing within a controlled isolator environment and within a BSC.
  • Conducts training for less experienced personnel
  • Work in accordance with site and company EHS programs.
  • Work in accordance with regulations, detailed protocols, Batch Record’s, SOP’s and Work Instructions.
  • Prepare and process components, materials and equipment for aseptic fill finish activities, operate filling equipment and perform aseptic manipulations, able to inspect finished vials and perform labeling activities to support shipment.

Work Hours:

  • The incumbent will onboard and support project activities Monday through Friday, 8:00 AM to 5:00 PM. The position may transition to a 12-hour day time rotation as the site becomes operational.
  • May require overtime to work evenings, weekends or holidays, as required to meet project timelines.

Experience and Skills

Requirements:

  • Must be able to work in a fast-paced environment.
  • A strong attention to detail.
  • Work towards solutions to given problems and operate under cGMP requirements.
  • Work cross-functionally with support groups such as Facilities, Engineering, Contamination Control, Quality Control and Quality Assurance.
  • Qualify to work in aseptic environments to complete required production activities.
  • Maintain facility and room inspection readiness.
  • Ability to lift at least 50lbs.
  • Ability to aseptically gown and/or sterile gown as needed.

Knowledge, Skill and Requirements

Minimum Qualifications:

  • Bachelor’s Degree with 1-3 years of industry related experience in cGMP manufacturing.
  • High School diploma and 2-4 years’ industry related experience in cGMP manufacturing.
  • Independently motivated and can work within a cross-functional team

Preferred Qualifications:

  • Bachelor’s Degree with 2-4 years of Drug Product experience in cGMP manufacturing.
  • High School diploma with 3-5 years of Drug Product experience in cGMP manufacturing.

 

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.