Associate Specialist (Cell Therapy Manufacturing)

About the role

Support the start-up and cGMP operation of the new cell therapy manufacturing facility. Collaboration is key, and you will work together frequently with Process Development, Clinical Operations, Materials Management, and Quality Teams.

Responsibilities

• Author and execute manufacturing batch records, work instructions and/or SOPs, with a focus on 'right the first time'.
• Author and maintain bill of materials.
• Assist with batch record reconciliation and timely documentation.
• Document all activities to meet cGMP requirements.
• Assist with deviations/non-conformances/OOS investigations.
• Routinely monitor, clean, prepare and operate sophisticated automated cell processing, cell expansion and filling equipment in Grades A & B cleanroom environment.
• Train other personnel on aseptic processing, equipment operation, cGMPs, documentation, technical theory, or other tasks.
• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as needed.
• Participate in tech transfer activities.
• Support process development of platform processes, contributing to the plans and designs of studies/experiments.
• Modify or improve processes and systems, depending on purpose of experiments.
• Provide technical instruction to the team and allocate administrative work where possible—assigning tasks to other manufacturing staff, leading activities on the manufacturing floor, communicating product status at shift change, troubleshooting processing and equipment issues.
• Ensure a safe work environment in accordance with standards.

Requirements

• Bachelor's degree and 0-3 years of general cGMP manufacturing experience.
• Master's degree and 0-2 years of general cGMP manufacturing experience.
• Basic knowledge in biologics manufacturing process, cell culture and/or vector products.
• Technical proficiency in aseptic technique and working with manufacturing equipment in open and closed systems.
• Working knowledge of automated manufacturing equipment and/or process analytical technologies.
• Proficiency in Microsoft Word, Excel and data analysis.
• Previous manufacturing or process development experience with cell therapy or vector products.
• Dynamic individual with the ability to communicate and engage others.
• Independent and self-starting; ability to work with minimal supervision.
• Demonstrate flexibility and willingness to change ways of working/identify opportunities to improve processes within cGMP clinical manufacturing environment.
• Good communication skills (essential for cross-functional and multi-room collaboration).
• Adaptability.
• Aseptic technique/on-the-floor manufacturing experience.

Schedule

Fully onsite, Wednesday – Saturday, 7:00 AM – 5:30 PM (first 30–45 days: 8:00 AM – 5:00 PM).

Benefits

• Healthcare Insurance: Eligible employees and dependents receive coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) Plan: Synectics offers all employees aged 21 or older the opportunity to invest in the 401(k) Plan on the first of the month following at least one calendar year of employment.