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Manufacturing Assoc. II
Job Number: 2022-42342
Category: Biotechnology
Location: Fall River, MA
Shift: Day
Exempt/Non-Exempt: Non Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MAB-South Coast - W416890
Job Type: Full-Time
Salary Grade: 05
Union Code: Non Union Position-W25-Non Unit Classified
Num. Openings: 1
Post Date: Dec. 24, 2022

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 cGMP guidelines.  

MAJOR RESPONSIBILITIES:

  • Perform and may supervise manufacturing activities for a variety of clinical and commercial products which ma include bioreactor operation, purification, filling, packaging, and labeling
  • Perform manufacturing activities of licensed and clinical products in an aseptic environment
  • Perform autoclaving, cleaning and sterilization operations 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
  • Performs additional job related duties as required

REQUIRED QUALIFICATIONS:

  • Requires a bachelors degree in a scientific discipline, preferably biology, with a minimum 2 years of relevant experience, or equivalent
  • Ability to follow instructions precisely , recognize deviations, and recommend corrective action within scope of training
  • Prior experience in a cGxP regulated environment. Working knowledge of CFR 21
  • Capable of moderately complex troubleshooting
  • Computer literate and proficient in MS Word, Excel and other relevant electronic systems
  • Strong problem solving, time management and organizational skills.  Demonstrated ability to multitask
  • and consistently meet deadlines
  • 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 and to train 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 manufacturing
  • Experience in the following areas is preferred: aseptic filling, cell culture, purification
  • 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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