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Manufacturing Associate II
Job Number: 2019-33183Category: 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: June 9, 2019
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
- Requires a bachelor’s 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