• MassBiologics
  • $94,360.00 -141,170.00/year*
  • Mattapan , MA
  • Manufacturing
  • Full-Time
  • 8 Almont St


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Overview
GENERAL SUMMARY OF POSITION:
Manufactures, assembles, and labels clinical and commercial biologic products. Operates manual and semi-automatic equipment 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
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.
Ensure maintenance of records and logbooks
Tabulate data and prepares reports
Train lower level personnel in manufacturing processes and ensures training records are up to date
Serve as department liaison with support departments such as compliance, facilities, engineering and quality groups
Review records/documents and ensures compliance with cGMPs
Write SOPs, batch records, technical reports and other cGMP documents as required
Ensure media, glassware 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
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
5 years of relevant experience or equivalent
Ability to follow instructions precisely , recognize deviations, and recommend corrective action
Prior experience in a cGxP regulated environment. Strong working knowledge of CFR 21
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
Strong critical thinking, 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 (up, down, and laterally) 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 manufacturing
Experience in the following areas 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 a minimum of 50 lbs using proper lifting technique
Associated topics: fertilize, forklift, fork lift, lawn, management, manufacture, production management, ship, transplant, watering

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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