Pharma Manufacturing Associate (2nd Shfit)

Intellyk; Boston (MA); On-site; USD 55,000 - 66,000; Full time

Job summary

Intellyk is seeking a Manufacturing Specialist to lead clincial cell therapy production in a cGMP setting. You will author and review batch records, ensure aseptic technique, and drive right first time execution.

The role requires 5–6 years of cgMP cell therapy manufacturing experience, leadership abilities, and the capacity to work in a cleanroom environment with physical tasks such as moving materials up to 50 pounds.

Qualifications

• Requires 5 to 6 years of cgmp cell therapy manufacturing experience.
• Experience authoring and reviewing batch records and procedures.
• Strong aseptic technique and cleanroom experience.
• Ability to lead and train team members.
• Willingness to participate in tech transfer and SOP development.
• Must be able to stand in cleanroom and move materials up to 50 pounds.

Responsibilities

• Perform clinical product manufacturing for cell therapy according to cGMP standards.
• Demonstrates and assists others with aseptic technique.
• Participate in technology transfer and SOP development with Development and Quality groups.
• Ensure raw materials are identified and available in time for manufacturing activities.
• Coordinate resources with Operations to ensure smooth production.
• Maintain cGMP compliance through consistent execution.
• Lead by example and foster collaboration within the team.
• Work in a cleanroom and office; may move equipment weighing up to 50 pounds.

Skills

Cell therapy manufacturing

Leadership

Document writing

SOP adherence

Batch records

Job description

Job description:

Job Description

Manufacturing Specialist

Requires 5 to 6 years of cGMP cell therapy manufacturing experience. Should have prior document writing experience. Leadership Experience is a big plus. Serves as the floor SME, authors and reviews batch records and procedures the same day, drives right first time execution, supports technical projects and tech transfer, completes an accelerated onboarding.

First Shift: Sunday - Thursday 7am - 3:30PM

• Perform clinical product manufacturing for cell therapy according to cGMP standards - Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, and reporting deviations
• Demonstrates and assists others with aseptic technique
• May participate in technology transfer and final process development from the Development to the Manufacturing group - Occasionally supports the development of Standard Operating Procedures (SOPs) or other documentation for manufacturing in collaboration with Development and Quality groups.
• Ensures raw materials are identified and available in time for manufacturing activities - Transfer raw material inside cleanroom suite using sanitizing reagents
• Supports Operations group to ensure proper coordination of resources
• Ensures cGMP compliance through consistent execution
• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking
• Other duties and projects as assigned to meet departmental requirements
• Works in a cleanroom and office setting
• Must be able to remain in a stationary position 50% during processing activities
• Frequently move about inside the cleanroom to accomplish process tasks
• Occasionally moves lab equipment and materials weighing up to 50 pounds
• Compressed gasses and LN2 are used in this process

Pay: $40.62 - $48.00 per hour

Application Question(s):

• Application Question(s):

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Work Location: In person