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Manufacturing Associate IV
Job Number: 2022-41292Category: Biotechnology
Location: Mattapan, MA
Shift: Day
Exempt/Non-Exempt: Non Exempt
Business Unit: MassBiologics
Department: MassBiological Labs - MassBiologics of UMass Chan - W416800
Job Type: Full-Time
Salary Grade: 07
Union Code: Non Union Position-W25-Non Unit Classified
Num. Openings: 1
Post Date: Nov. 24, 2022
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.
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
REQUIRED QUALIFICATIONS:
- Bachelor's degree in a scientific discipline, preferably biology, or equivalent experience
- 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
- Ability to work effectively both independently and as a member of a team
PREFERRED QUALIFICATIONS:
- Experience in the following areas preferred: aseptic filling, cell culture, purification