Associate Specialist (Cell Therapy Manufacturing)

Description:

• Position will 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.

• Author and execute manufacturing batch records, work instructions and/or SOPs, with a focus 'right the first time'.

• Author and maintain bill of materials.

• Assist with batch record reconciliation and timely documentation.

• Documentation of 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.

• May modify or improve processes and systems, depending on purpose of experiments

• Provides technical instruction to the team and allocates administrative work where possible -assigning tasks to other manufacturing staff, leading activities on manufacturing floor, communicating to staff about product status at shift change, troubleshooting processing and equipment issues.

• Ensures a safe work environment in accordance with standards.

• Weekend work may be required.

Qualification:

• Bachelor's or Master's degree in life sciences, engineering, or a related field

• 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 (will be working in different rooms and cross functionally so this is really important for success)

• Aseptic technique/On the floor manufacturing experience

• Working Days/Hours: M-F for first 30-35 days; afterwards shift should be Wednesday-Saturday 0700-1730

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities